Trial Outcomes & Findings for Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults (NCT NCT01908842)
NCT ID: NCT01908842
Last Updated: 2017-05-10
Results Overview
Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
759 participants
Primary outcome timeframe
Day 3 and Day 15
Results posted on
2017-05-10
Participant Flow
A total of 759 patients were enrolled. One patient who was randomized did not receive study drug, making the participant flow total 758.
Participant milestones
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
Days 1-2: BNX sublingual tablets (blinded induction); Days 3 to 14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
Days 1-2: Buprenorphine (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
Induction
STARTED
|
383
|
375
|
|
Induction
COMPLETED
|
357
|
344
|
|
Induction
NOT COMPLETED
|
26
|
31
|
|
Switch to Other BNX Formulation (Day 15)
STARTED
|
357
|
344
|
|
Switch to Other BNX Formulation (Day 15)
COMPLETED
|
287
|
279
|
|
Switch to Other BNX Formulation (Day 15)
NOT COMPLETED
|
70
|
65
|
|
Day 22: Film (Col 1); Tablets (Col 2)
STARTED
|
287
|
279
|
|
Day 22: Film (Col 1); Tablets (Col 2)
COMPLETED
|
262
|
262
|
|
Day 22: Film (Col 1); Tablets (Col 2)
NOT COMPLETED
|
25
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
Baseline characteristics by cohort
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=383 Participants
Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=375 Participants
Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit
|
Total
n=758 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
35.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
318 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
630 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Height
|
171.5 cm
STANDARD_DEVIATION 9.3 • n=5 Participants
|
172.3 cm
STANDARD_DEVIATION 9.4 • n=7 Participants
|
171.9 cm
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Weight
|
77.1 kg
STANDARD_DEVIATION 18.7 • n=5 Participants
|
78.3 kg
STANDARD_DEVIATION 18.4 • n=7 Participants
|
77.7 kg
STANDARD_DEVIATION 18.6 • n=5 Participants
|
|
Body mass index
|
26.2 kg/m2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
26.3 kg/m2
STANDARD_DEVIATION 5.7 • n=7 Participants
|
26.3 kg/m2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Duration of opioid use
|
10.7 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
10.6 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3 and Day 15Population: Per protocol population
Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.
Outcome measures
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=329 Participants
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=326 Participants
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
Primary Endpoints of Retention in Treatment at Days 3 and 15
Retention at Day 3
|
309 participants
|
302 participants
|
|
Primary Endpoints of Retention in Treatment at Days 3 and 15
Retention at Day 15
|
273 participants
|
269 participants
|
SECONDARY outcome
Timeframe: Days 1 and 2Population: Full Analysis Population - number of enrolled patients at the beginning of the measurement period
Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable
Outcome measures
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=380 Participants
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=373 Participants
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Baseline
|
15.0 units on a scale
Standard Deviation 4.2
|
14.9 units on a scale
Standard Deviation 4.3
|
|
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Day 1 0.5 h post dose
|
10.5 units on a scale
Standard Deviation 4.6
|
10.3 units on a scale
Standard Deviation 4.7
|
|
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Day 1 1.5 h post dose
|
8.8 units on a scale
Standard Deviation 4.6
|
8.3 units on a scale
Standard Deviation 4.5
|
|
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Day 1 3 h post dose
|
6.6 units on a scale
Standard Deviation 5.1
|
6.1 units on a scale
Standard Deviation 5.1
|
|
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Day 1 6 h post dose
|
5.3 units on a scale
Standard Deviation 4.1
|
5.4 units on a scale
Standard Deviation 4.6
|
|
Clinical Opiate Withdrawal Scale (COWS) Scores: Induction
Day 2
|
8.0 units on a scale
Standard Deviation 4.9
|
7.6 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Days 3 through 22Population: Full analysis population - - number of enrolled patients at the beginning of the measurement period
Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable
Outcome measures
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=355 Participants
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=344 Participants
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
COWS Total Scores: Stabilization/Maintenance
Day 3
|
6.0 units on a scale
Standard Deviation 4.2
|
5.9 units on a scale
Standard Deviation 4.4
|
|
COWS Total Scores: Stabilization/Maintenance
Day 4
|
5.2 units on a scale
Standard Deviation 4.0
|
5.1 units on a scale
Standard Deviation 4.3
|
|
COWS Total Scores: Stabilization/Maintenance
Day 8
|
4.8 units on a scale
Standard Deviation 3.9
|
4.6 units on a scale
Standard Deviation 3.9
|
|
COWS Total Scores: Stabilization/Maintenance
Day 15
|
4.1 units on a scale
Standard Deviation 3.5
|
3.7 units on a scale
Standard Deviation 3.4
|
|
COWS Total Scores: Stabilization/Maintenance
Day 22: Film (col 1); Tablets (col 2)
|
3.4 units on a scale
Standard Deviation 3.3
|
3.3 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Days 1 and 2Population: Full analysis population - number of enrolled patients at the beginning of the measurement period
Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable
Outcome measures
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=376 Participants
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=367 Participants
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Baseline
|
31.7 units on a scale
Standard Deviation 13.5
|
33.0 units on a scale
Standard Deviation 13.2
|
|
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Day 1 0.5 h post dose
|
22.7 units on a scale
Standard Deviation 13.9
|
23.0 units on a scale
Standard Deviation 13.6
|
|
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Day 1 1.5 h post dose
|
19.1 units on a scale
Standard Deviation 13.5
|
17.8 units on a scale
Standard Deviation 13.0
|
|
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Day 1 3 h post dose
|
13.6 units on a scale
Standard Deviation 12.7
|
13.0 units on a scale
Standard Deviation 12.5
|
|
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Day 1 6 h post dose
|
10.7 units on a scale
Standard Deviation 10.2
|
11.1 units on a scale
Standard Deviation 11.8
|
|
Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction
Day 2
|
16.7 units on a scale
Standard Deviation 12.3
|
16.4 units on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Days 3 through 22Population: Full Analysis Population - number of enrolled patients at the beginning of the measurement period
Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable
Outcome measures
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=355 Participants
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=342 Participants
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
SOWS Total Scores: Stabilization/Maintenance
Day 3
|
11.9 units on a scale
Standard Deviation 10.4
|
12.6 units on a scale
Standard Deviation 11.2
|
|
SOWS Total Scores: Stabilization/Maintenance
Day 4
|
10.1 units on a scale
Standard Deviation 9.2
|
10.2 units on a scale
Standard Deviation 10.3
|
|
SOWS Total Scores: Stabilization/Maintenance
Day 8
|
9.0 units on a scale
Standard Deviation 9.2
|
8.8 units on a scale
Standard Deviation 9.6
|
|
SOWS Total Scores: Stabilization/Maintenance
Day 15
|
7.2 units on a scale
Standard Deviation 7.7
|
6.7 units on a scale
Standard Deviation 8.1
|
|
SOWS Total Scores: Stabilization/Maintenance
Day 22: Film (col 1); Tablets (col 2)
|
6.8 units on a scale
Standard Deviation 7.9
|
7.3 units on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Days 1 and 2Population: Full Analysis Population - number of enrolled patients at the beginning of the measurement period
Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")
Outcome measures
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=380 Participants
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=373 Participants
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
Visual Analog Scale (VAS) Cravings: Induction
Baseline
|
69.2 units on a scale
Standard Deviation 23.5
|
71.9 units on a scale
Standard Deviation 22.0
|
|
Visual Analog Scale (VAS) Cravings: Induction
Day 1 0.5 h post dose
|
56.8 units on a scale
Standard Deviation 26.5
|
58.2 units on a scale
Standard Deviation 26.4
|
|
Visual Analog Scale (VAS) Cravings: Induction
Day 1 1.5 h post dose
|
49.2 units on a scale
Standard Deviation 28.9
|
48.8 units on a scale
Standard Deviation 27.9
|
|
Visual Analog Scale (VAS) Cravings: Induction
Day 1 3 h post dose
|
36.0 units on a scale
Standard Deviation 28.2
|
34.9 units on a scale
Standard Deviation 27.8
|
|
Visual Analog Scale (VAS) Cravings: Induction
Day 1 6 h post dose
|
30.2 units on a scale
Standard Deviation 26.2
|
29.6 units on a scale
Standard Deviation 26.9
|
|
Visual Analog Scale (VAS) Cravings: Induction
Day 2
|
45.3 units on a scale
Standard Deviation 28.7
|
44.9 units on a scale
Standard Deviation 28.4
|
SECONDARY outcome
Timeframe: Days 3 through 22Population: Full analysis population - number of enrolled patients at the beginning of the measurement period
Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 ("no cravings") to 100 ("most intense craving I have ever had")
Outcome measures
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=356 Participants
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=344 Participants
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
VAS Craving Scores: Stabilization/Maintenance
Day 3
|
33.7 units on a scale
Standard Deviation 27.0
|
34.5 units on a scale
Standard Deviation 28.2
|
|
VAS Craving Scores: Stabilization/Maintenance
Day 4
|
29.1 units on a scale
Standard Deviation 26.2
|
28.5 units on a scale
Standard Deviation 26.4
|
|
VAS Craving Scores: Stabilization/Maintenance
Day 8
|
26.2 units on a scale
Standard Deviation 26.5
|
23.7 units on a scale
Standard Deviation 24.7
|
|
VAS Craving Scores: Stabilization/Maintenance
Day 15
|
21.6 units on a scale
Standard Deviation 23.9
|
19.1 units on a scale
Standard Deviation 23.4
|
|
VAS Craving Scores: Stabilization/Maintenance
Day 22: Film (col 1); Tablets (col 2)
|
20.2 units on a scale
Standard Deviation 22.9
|
20.9 units on a scale
Standard Deviation 23.8
|
Adverse Events
BNX Tablets, Then OL BNX Tablets, Then BNX Film
Serious events: 3 serious events
Other events: 61 other events
Deaths: 0 deaths
Buprenorphine, Then OL BNX Film, Then BNX Tablets
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=383 participants at risk
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=375 participants at risk
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
Injury, poisoning and procedural complications
Worsening of pre-existing condition (foreign body in neck)
|
0.26%
1/383 • Number of events 1 • Monitoring for adverse events was conducted from baseline through Day 22.
|
0.00%
0/375 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
0.26%
1/383 • Number of events 1 • Monitoring for adverse events was conducted from baseline through Day 22.
|
0.00%
0/375 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Hepatobiliary disorders
Elevated Transaminases
|
0.26%
1/383 • Number of events 1 • Monitoring for adverse events was conducted from baseline through Day 22.
|
0.00%
0/375 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/383 • Monitoring for adverse events was conducted from baseline through Day 22.
|
0.27%
1/375 • Number of events 1 • Monitoring for adverse events was conducted from baseline through Day 22.
|
Other adverse events
| Measure |
BNX Tablets, Then OL BNX Tablets, Then BNX Film
n=383 participants at risk
Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
|
Buprenorphine, Then OL BNX Film, Then BNX Tablets
n=375 participants at risk
Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.2%
20/383 • Number of events 20 • Monitoring for adverse events was conducted from baseline through Day 22.
|
5.1%
19/375 • Number of events 19 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
12/383 • Number of events 12 • Monitoring for adverse events was conducted from baseline through Day 22.
|
2.9%
11/375 • Number of events 11 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
8/383 • Number of events 8 • Monitoring for adverse events was conducted from baseline through Day 22.
|
4.0%
15/375 • Number of events 15 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
8/383 • Number of events 8 • Monitoring for adverse events was conducted from baseline through Day 22.
|
0.53%
2/375 • Number of events 2 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Psychiatric disorders
Insomnia
|
1.3%
5/383 • Number of events 5 • Monitoring for adverse events was conducted from baseline through Day 22.
|
1.1%
4/375 • Number of events 4 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Nervous system disorders
Somnolence
|
1.6%
6/383 • Number of events 6 • Monitoring for adverse events was conducted from baseline through Day 22.
|
0.53%
2/375 • Number of events 2 • Monitoring for adverse events was conducted from baseline through Day 22.
|
|
Gastrointestinal disorders
Constipation
|
1.0%
4/383 • Number of events 4 • Monitoring for adverse events was conducted from baseline through Day 22.
|
0.80%
3/375 • Number of events 3 • Monitoring for adverse events was conducted from baseline through Day 22.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place