Trial Outcomes & Findings for The Plecanatide Chronic Idiopathic Constipation (CIC) Study (NCT NCT01429987)
NCT ID: NCT01429987
Last Updated: 2019-05-28
Results Overview
A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
951 participants
Primary outcome timeframe
12-Week Treatment Period
Results posted on
2019-05-28
Participant Flow
Participant milestones
| Measure |
Plecanatide 0.3 mg
Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
|
Plecanatide 1.0 mg
Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
|
Plecanatide 3.0 mg
Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
|
Placebo
Subjects received placebo orally for 12 consecutive weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
238
|
238
|
238
|
237
|
|
Overall Study
COMPLETED
|
189
|
176
|
202
|
171
|
|
Overall Study
NOT COMPLETED
|
49
|
62
|
36
|
66
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
Baseline characteristics by cohort
| Measure |
Plecanatide 0.3 mg
n=237 Participants
Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 Participants
Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 Participants
Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
|
Placebo
n=234 Participants
Subjects received placebo orally for 12 consecutive weeks
|
Total
n=946 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.8 years
n=5 Participants
|
47.1 years
n=7 Participants
|
47.1 years
n=5 Participants
|
46.3 years
n=4 Participants
|
47.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
203 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
207 Participants
n=4 Participants
|
817 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.
A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
Outcome measures
| Measure |
Plecanatide 0.3 mg
n=237 Participants
Subjects received plecanatide 0.3 mg for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 Participants
Subjects received plecanatide 1.0 mg for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 Participants
Subjects received plecanatide 3.0 mg for 12 consecutive weeks
|
Placebo
n=234 Participants
Subjects received placebo for 12 consecutive weeks
|
|---|---|---|---|---|
|
Overall Responder 9/12 Weeks
|
18.6 % of Overall Responder 9/12 weeks
|
16.8 % of Overall Responder 9/12 weeks
|
19.0 % of Overall Responder 9/12 weeks
|
10.7 % of Overall Responder 9/12 weeks
|
SECONDARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.
The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Outcome measures
| Measure |
Plecanatide 0.3 mg
n=237 Participants
Subjects received plecanatide 0.3 mg for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 Participants
Subjects received plecanatide 1.0 mg for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 Participants
Subjects received plecanatide 3.0 mg for 12 consecutive weeks
|
Placebo
n=234 Participants
Subjects received placebo for 12 consecutive weeks
|
|---|---|---|---|---|
|
Change From Baseline in 12-week CSBM Weekly Frequency Rate
|
1.60 CSBMs per week
Standard Error 0.159
|
1.81 CSBMs per week
Standard Error 0.157
|
2.18 CSBMs per week
Standard Error 0.159
|
1.09 CSBMs per week
Standard Error 0.162
|
SECONDARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.
The number of Spontaneous Bowl Movements experienced per week.
Outcome measures
| Measure |
Plecanatide 0.3 mg
n=237 Participants
Subjects received plecanatide 0.3 mg for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 Participants
Subjects received plecanatide 1.0 mg for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 Participants
Subjects received plecanatide 3.0 mg for 12 consecutive weeks
|
Placebo
n=234 Participants
Subjects received placebo for 12 consecutive weeks
|
|---|---|---|---|---|
|
Change From Baseline in 12-week SBM Weekly Frequency Rate
|
2.20 SBMs per week
Standard Error 0.190
|
2.38 SBMs per week
Standard Error 0.188
|
3.00 SBMs per week
Standard Error 0.191
|
1.35 SBMs per week
Standard Error 0.194
|
SECONDARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.
The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \[BSFS\] from 1 to 7. 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on its surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces (entirely liquid)
Outcome measures
| Measure |
Plecanatide 0.3 mg
n=237 Participants
Subjects received plecanatide 0.3 mg for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 Participants
Subjects received plecanatide 1.0 mg for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 Participants
Subjects received plecanatide 3.0 mg for 12 consecutive weeks
|
Placebo
n=234 Participants
Subjects received placebo for 12 consecutive weeks
|
|---|---|---|---|---|
|
Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period
|
1.28 scores on a scale
Standard Error 0.090
|
1.70 scores on a scale
Standard Error 0.090
|
1.97 scores on a scale
Standard Error 0.089
|
0.87 scores on a scale
Standard Error 0.091
|
SECONDARY outcome
Timeframe: 12-Week Treatment PeriodPopulation: The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.
The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst
Outcome measures
| Measure |
Plecanatide 0.3 mg
n=237 Participants
Subjects received plecanatide 0.3 mg for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 Participants
Subjects received plecanatide 1.0 mg for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 Participants
Subjects received plecanatide 3.0 mg for 12 consecutive weeks
|
Placebo
n=234 Participants
Subjects received placebo for 12 consecutive weeks
|
|---|---|---|---|---|
|
Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score
|
-1.25 scores on a scale
Standard Error 0.142
|
-1.46 scores on a scale
Standard Error 0.142
|
-1.73 scores on a scale
Standard Error 0.143
|
-1.04 scores on a scale
Standard Error 0.144
|
Adverse Events
Plecanatide 0.3 mg
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Plecanatide 1.0 mg
Serious events: 1 serious events
Other events: 79 other events
Deaths: 0 deaths
Plecanatide 3.0 mg
Serious events: 2 serious events
Other events: 92 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Plecanatide 0.3 mg
n=237 participants at risk
Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 participants at risk
Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 participants at risk
Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
|
Placebo
n=236 participants at risk
Subjects received placebo orally for 12 consecutive weeks
|
|---|---|---|---|---|
|
General disorders
Non-cardiac chest pain
|
0.42%
1/237 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/236 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
General disorders
Asthenia
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/237 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/236
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/238 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/236
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/237 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/236
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/237 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/236
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/236 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/236 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/236 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Vascular disorders
Hypertension
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/238
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.00%
0/237
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
0.42%
1/236 • Number of events 1
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
Other adverse events
| Measure |
Plecanatide 0.3 mg
n=237 participants at risk
Subjects received plecanatide 0.3 mg orally for 12 consecutive weeks
|
Plecanatide 1.0 mg
n=238 participants at risk
Subjects received plecanatide 1.0 mg orally for 12 consecutive weeks
|
Plecanatide 3.0 mg
n=237 participants at risk
Subjects received plecanatide 3.0 mg orally for 12 consecutive weeks
|
Placebo
n=236 participants at risk
Subjects received placebo orally for 12 consecutive weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
13/237 • Number of events 13
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
8.4%
20/238 • Number of events 21
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
9.7%
23/237 • Number of events 24
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
1.3%
3/236 • Number of events 3
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.5%
6/237 • Number of events 6
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
3.8%
9/238 • Number of events 9
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
5.1%
12/237 • Number of events 15
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
4.7%
11/236 • Number of events 11
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
5/237 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
5.0%
12/238 • Number of events 13
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
3.4%
8/237 • Number of events 8
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
2.1%
5/236 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Gastrointestinal disorders
Abdominal Distension
|
2.1%
5/237 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
4.2%
10/238 • Number of events 10
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
3.8%
9/237 • Number of events 10
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
2.1%
5/236 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
5/237 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
1.3%
3/238 • Number of events 3
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
5.9%
14/237 • Number of events 14
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
2.1%
5/236 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Infections and infestations
Urinary Tract Infection
|
2.1%
5/237 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
3.8%
9/238 • Number of events 10
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
3.4%
8/237 • Number of events 9
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
2.5%
6/236 • Number of events 6
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Infections and infestations
Upper Respiratory tract infection
|
2.5%
6/237 • Number of events 6
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
2.1%
5/238 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
3.8%
9/237 • Number of events 10
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
2.1%
5/236 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
|
Nervous system disorders
Headache
|
4.2%
10/237 • Number of events 10
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
4.6%
11/238 • Number of events 11
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
3.8%
9/237 • Number of events 9
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
2.1%
5/236 • Number of events 5
In the Participate Flow Module-Overall Study, a total of 951 patients were randomized; 3 patients were not treated. Therefore, only 948 treated patients were included in the population at risk. The total number of 948 patients also applied to Other Adverse Events table.
|
Additional Information
Dr. Patrick H. Griffin
Synergy Pharmaceuticals Inc.
Phone: 212-297-0020
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place