Trial Outcomes & Findings for Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users (NCT NCT04995029)
NCT ID: NCT04995029
Last Updated: 2026-02-06
Results Overview
A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 20 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
785 participants
Primary outcome timeframe
Weeks 20 to 38
Results posted on
2026-02-06
Participant Flow
Study Period was 26 Oct 2021 to 26 Jun 2024.
Induction Phase: Participants were required to be in withdrawal (COWS score ≥8) to receive transmucosal (TM) buprenorphine (BUP). To receive RBP-6000, the participant did not display any allergic/ hypersensitivity reaction to TM BUP, did not experience precipitated withdrawal symptoms from the most recent TM BUP administration that would prevent RBP-6000 injection, and was not sedated. For standard of care, the participant had been dose-adjusted onto TM BUP for ≥7 days.
Participant milestones
| Measure |
Induction Phase: Rapid Induction
Participants will receive 4 mg transmucosal buprenorphine on Day 1. Participants meeting eligibility requirements will then receive 300 mg extended-release buprenorphine by subcutaneous injection at least 1 hour later and a second dose on Day 8.
Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Induction Phase: Standard of Care Induction
Participants will receive transmucosal buprenorphine for a minimum of 7 days per applicable product labelling information. Participants meeting eligibility requirements will receive 300 mg extended-release buprenorphine by subcutaneous injection on Day 1 and a second dose on Day 8.
Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 100 mg
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34).
Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34).
Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|---|---|
|
Induction Phase
STARTED
|
518
|
267
|
0
|
0
|
|
Induction Phase
Received TM BUP
|
513
|
264
|
0
|
0
|
|
Induction Phase
Received RBP-6000 Injection 1
|
444
|
159
|
0
|
0
|
|
Induction Phase
Received RBP-6000 Injection 2
|
339
|
145
|
0
|
0
|
|
Induction Phase
COMPLETED
|
298
|
137
|
0
|
0
|
|
Induction Phase
NOT COMPLETED
|
220
|
130
|
0
|
0
|
|
Maintenance Phase
STARTED
|
0
|
0
|
218
|
217
|
|
Maintenance Phase
COMPLETED
|
0
|
0
|
134
|
128
|
|
Maintenance Phase
NOT COMPLETED
|
0
|
0
|
84
|
89
|
Reasons for withdrawal
| Measure |
Induction Phase: Rapid Induction
Participants will receive 4 mg transmucosal buprenorphine on Day 1. Participants meeting eligibility requirements will then receive 300 mg extended-release buprenorphine by subcutaneous injection at least 1 hour later and a second dose on Day 8.
Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Induction Phase: Standard of Care Induction
Participants will receive transmucosal buprenorphine for a minimum of 7 days per applicable product labelling information. Participants meeting eligibility requirements will receive 300 mg extended-release buprenorphine by subcutaneous injection on Day 1 and a second dose on Day 8.
Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 100 mg
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34).
Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34).
Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|---|---|
|
Induction Phase
Did not meet eligibility criteria
|
5
|
2
|
0
|
0
|
|
Induction Phase
Withdrawal by Subject
|
85
|
42
|
0
|
0
|
|
Induction Phase
Lost to Follow-up
|
103
|
67
|
0
|
0
|
|
Induction Phase
Adverse Event
|
5
|
3
|
0
|
0
|
|
Induction Phase
Physician Decision
|
11
|
8
|
0
|
0
|
|
Induction Phase
Incarceration
|
6
|
3
|
0
|
0
|
|
Induction Phase
Not otherwise described
|
5
|
5
|
0
|
0
|
|
Maintenance Phase
Lost to Follow-up
|
0
|
0
|
51
|
44
|
|
Maintenance Phase
Did not meet eligibility criteria
|
0
|
0
|
0
|
1
|
|
Maintenance Phase
Adverse Event
|
0
|
0
|
0
|
1
|
|
Maintenance Phase
Physician Decision
|
0
|
0
|
8
|
4
|
|
Maintenance Phase
Withdrawal by Subject
|
0
|
0
|
17
|
31
|
|
Maintenance Phase
Incarceration
|
0
|
0
|
4
|
3
|
|
Maintenance Phase
Not otherwise described
|
0
|
0
|
2
|
3
|
|
Maintenance Phase
Pregnancy
|
0
|
0
|
2
|
2
|
Baseline Characteristics
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
Baseline characteristics by cohort
| Measure |
Induction Phase: Rapid Induction
n=474 Participants
Participants will receive 4 mg transmucosal buprenorphine on Day 1. Participants meeting eligibility requirements will then receive 300 mg extended-release buprenorphine by subcutaneous injection at least 1 hour later and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Induction Phase: Standard of Care Induction
n=255 Participants
Participants will receive transmucosal buprenorphine for a minimum of 7 days per applicable product labelling information. Participants meeting eligibility requirements will receive 300 mg extended-release buprenorphine by subcutaneous injection on Day 1 and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=217 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Total
n=1164 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
Maintenance Phase · Between 18 and 65 years
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
216 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
214 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
430 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Age, Categorical
Induction Phase · <=18 years
|
1 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
2 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Age, Categorical
Induction Phase · Between 18 and 65 years
|
470 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
252 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
722 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Age, Categorical
Induction Phase · >=65 years
|
3 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
2 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
5 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Age, Categorical
Maintenance Phase · <=18 years
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Age, Categorical
Maintenance Phase · >=65 years
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
2 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
3 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
5 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Age, Continuous
Induction Phase
|
40.9 years
STANDARD_DEVIATION 10.68 • n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
40.4 years
STANDARD_DEVIATION 9.77 • n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
40.7 years
STANDARD_DEVIATION 10.37 • n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Age, Continuous
Maintenance Phase
|
—
|
—
|
41.5 years
STANDARD_DEVIATION 10.58 • n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
41.7 years
STANDARD_DEVIATION 11.17 • n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
41.6 years
STANDARD_DEVIATION 10.87 • n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Sex: Female, Male
Induction Phase · Female
|
202 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
121 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
323 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Sex: Female, Male
Induction Phase · Male
|
272 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
134 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
406 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Sex: Female, Male
Maintenance Phase · Female
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
95 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
92 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
187 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Sex: Female, Male
Maintenance Phase · Male
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
123 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
125 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
248 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Ethnicity (NIH/OMB)
Induction Phase · Hispanic or Latino
|
76 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
32 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
108 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Ethnicity (NIH/OMB)
Induction Phase · Not Hispanic or Latino
|
394 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
220 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
614 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Ethnicity (NIH/OMB)
Induction Phase · Unknown or Not Reported
|
4 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
3 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
7 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Ethnicity (NIH/OMB)
Maintenance Phase · Hispanic or Latino
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
25 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
37 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
62 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Ethnicity (NIH/OMB)
Maintenance Phase · Not Hispanic or Latino
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
191 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
178 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
369 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Ethnicity (NIH/OMB)
Maintenance Phase · Unknown or Not Reported
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
2 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
2 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
4 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Induction Phase · American Indian or Alaska Native
|
4 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
2 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
6 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Induction Phase · Asian
|
1 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Induction Phase · Native Hawaiian or Other Pacific Islander
|
4 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
5 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Induction Phase · Black or African American
|
85 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
37 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
122 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Induction Phase · White
|
358 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
207 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
565 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Induction Phase · More than one race
|
0 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Induction Phase · Unknown or Not Reported
|
22 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
8 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
30 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Maintenance Phase · American Indian or Alaska Native
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
5 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
6 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Maintenance Phase · Asian
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Maintenance Phase · Native Hawaiian or Other Pacific Islander
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
2 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
3 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Maintenance Phase · Black or African American
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
46 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
48 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
94 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Maintenance Phase · White
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
160 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
154 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
314 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Maintenance Phase · More than one race
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Race (NIH/OMB)
Maintenance Phase · Unknown or Not Reported
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
5 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
12 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
17 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Body Mass Index (kg/m2)
Induction Phase
|
26.83 kg/m2
STANDARD_DEVIATION 5.969 • n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
27.05 kg/m2
STANDARD_DEVIATION 6.305 • n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
26.91 kg/m2
STANDARD_DEVIATION 6.085 • n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Body Mass Index (kg/m2)
Maintenance Phase
|
—
|
—
|
26.96 kg/m2
STANDARD_DEVIATION 6.446 • n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
26.53 kg/m2
STANDARD_DEVIATION 5.860 • n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
26.75 kg/m2
STANDARD_DEVIATION 6.157 • n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Opioids Lifetime Use (years)
Induction Phase
|
14.8 years
STANDARD_DEVIATION 9.77 • n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
14.6 years
STANDARD_DEVIATION 9.37 • n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
14.7 years
STANDARD_DEVIATION 9.62 • n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Opioids Lifetime Use (years)
Maintenance Phase
|
—
|
—
|
14.8 years
STANDARD_DEVIATION 9.80 • n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
15.8 years
STANDARD_DEVIATION 10.84 • n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
15.3 years
STANDARD_DEVIATION 10.33 • n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Opioid Use Last 4 Weeks (days)
Induction Phase
|
27.8 days
STANDARD_DEVIATION 1.10 • n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
27.7 days
STANDARD_DEVIATION 1.28 • n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
27.8 days
STANDARD_DEVIATION 1.17 • n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Opioid Use Last 4 Weeks (days)
Maintenance Phase
|
—
|
—
|
27.7 days
STANDARD_DEVIATION 1.36 • n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
27.8 days
STANDARD_DEVIATION 0.89 • n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
27.8 days
STANDARD_DEVIATION 1.15 • n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Previous Opioid Overdose (Yes)
Induction Phase
|
158 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
85 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
243 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Previous Opioid Overdose (Yes)
Maintenance Phase
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
69 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
74 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
143 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Fentanyl UDS Result at Induction Day 1 Visit
Induction Phase
|
367 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
196 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
563 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Fentanyl UDS Result at Induction Day 1 Visit
Maintenance Phase
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
153 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
170 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
323 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Detoxed From Opioids Previously (Yes)
Induction Phase
|
354 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
193 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
547 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Detoxed From Opioids Previously (Yes)
Maintenance Phase
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
159 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
165 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
324 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Using Opioids Via Injection Route for Average of ≥5 Days Per Week in the Last 4 Weeks
Induction Phase
|
136 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
78 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
214 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Using Opioids Via Injection Route for Average of ≥5 Days Per Week in the Last 4 Weeks
Maintenance Phase
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
0 Participants
The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
80 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
77 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
157 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Induction Phase · Injection
|
131 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
79 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
210 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Induction Phase · Smoking
|
218 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
109 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
327 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Induction Phase · Oral
|
9 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
6 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
15 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Induction Phase · Snorting
|
114 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
60 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
174 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Induction Phase · Other
|
2 Participants
n=474 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=255 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
—
|
—
|
3 Participants
n=729 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Maintenance Phase · Injection
|
—
|
—
|
62 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
59 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
121 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Maintenance Phase · Smoking
|
—
|
—
|
92 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
94 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
186 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Maintenance Phase · Oral
|
—
|
—
|
2 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
8 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
10 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Maintenance Phase · Snorting
|
—
|
—
|
62 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
55 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
117 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Main Route of Opioid Use Last 4 Weeks
Maintenance Phase · Other
|
—
|
—
|
0 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
1 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Multiple Drug Class Use - Last 4 Weeks at Screening Self-report or UDS Prior to First DB Injection
|
—
|
—
|
217 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
213 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
430 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Fentanyl + Any Other Drug Class on Screening UDS
|
—
|
—
|
142 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
151 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
293 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Used Fentanyl ≥14 Times/Week in the Last 7 Days Prior to Screening
|
—
|
—
|
88 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
104 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
192 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Used Fentanyl Daily in the Last 7 Days at Screening
|
—
|
—
|
98 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
111 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
209 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
|
Used Fentanyl ≥14 Times/Week AND Daily in the Last 7 Days Prior to Screening
|
—
|
—
|
73 Participants
n=218 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
90 Participants
n=217 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
163 Participants
n=435 Participants • The number analyzed differs from overall because baseline data are presented separately for the Induction Phase and the Maintenance Phase.
|
PRIMARY outcome
Timeframe: Weeks 20 to 38Population: The Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 20 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38
|
44 Participants
|
50 Participants
|
PRIMARY outcome
Timeframe: Week 2Population: Evaluable Population for Treatment Retention/Discontinuation: For analysis pertaining to treatment retention and time to treatment discontinuation, the Substudy Full Analysis Set participants who discontinued treatment due to not meeting inclusion/exclusion criteria were also excluded. The participants were analyzed corresponding to the induction arm they received ("as treated", ie, actual arm).
Treatment retention at Injection 2 was defined as the proportion of participants receiving Injection 2 at the Week 2 Visit among those in the Evaluable Population for Treatment Retention/Discontinuation. Participants who received Injection 2 at Week 2 (nominal) Visit and those who missed Injection 2 at Week 2 (nominal) Visit but received Injection 3 at the Week 6 Day 36 Visit were counted as "Yes" for treatment retention at Injection 2; otherwise, participants were counted as "No".
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=470 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=253 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit
|
312 Participants
|
138 Participants
|
SECONDARY outcome
Timeframe: Weeks 10 to 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomised, and received at least 1 maintenance RBP-6000 injection post DB Randomisation. Participants were analysed according to the randomised treatment arm. This population served as the primary analysis population for efficacy analyses.
Participants' percentage of days opioids were used out of days assessed over Weeks 10 to 38 (inclusive), based on the TLFB for the prior week.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38
|
17.7 Participants' Percentage of Days
Standard Deviation 27.80
|
15.9 Participants' Percentage of Days
Standard Deviation 26.13
|
SECONDARY outcome
Timeframe: Weeks 10 to 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 10 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. Opioid use will be assessed at 15 visits between Weeks 10 and 38.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38
|
42 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Weeks 10 to 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38
|
31.1 Participants' Percentage of Visits
Standard Deviation 37.18
|
32.1 Participants' Percentage of Visits
Standard Deviation 36.94
|
SECONDARY outcome
Timeframe: Week 30 to 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% for the last 5 visits planned for urine drug screen (UDS) and TimeLine Follow Back (TLFB) over Weeks 30 to 38 (inclusive). Opioid abstinence is defined as a negative UDS result and negative responses to the TLFB interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38
|
50 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Week 30 to 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
A responder for daily opioid use is defined as a participant with 20% or less days of opioid use, based on the TimeLine Follow Backs (TLFBs) collected at the last 5 observed visits post randomization. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Responders for Daily Opioid Use
|
166 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: Week 2 to 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids at all assessments between Weeks 2 and 38. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Visits With Opioid Abstinence Overall
|
30.5 Participants' Percentage of Visits
Standard Deviation 33.24
|
32.0 Participants' Percentage of Visits
Standard Deviation 33.46
|
SECONDARY outcome
Timeframe: Week 2 to 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
For each participant, the percentage of days opioids were used out of days assessed over Weeks 2 to 38 (inclusive), based on the TimeLine Follow Back (TLFB) for the prior week of each visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Days Opioids Were Used Overall
|
18.3 Participants' Percentage of Days
Standard Deviation 25.14
|
17.6 Participants' Percentage of Days
Standard Deviation 25.04
|
SECONDARY outcome
Timeframe: Weeks 10 to 38Population: Full Analysis Set (FAS) Subpopulation: Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization; for this analysis, only participants who use opioids via the injection route for an average of ≥5 days per week in the last 4 weeks prior to Screening were included. Participants were analyzed according to the randomized treatment arm.
For participants who use opioids via the injection route for an average of 5 or more days per week in the last 4 weeks prior to Screening, the percentage of days opioids were used via the injection route out of days assessed based on the Timeline Follow Back (TLFB) interview for the prior week of each visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=65 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=61 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Days Opioids Were Used Via the Injection Route
|
9.9 Participants' Percentage of Days
Standard Deviation 23.79
|
8.5 Participants' Percentage of Days
Standard Deviation 19.01
|
SECONDARY outcome
Timeframe: Baseline to Week 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
The average number of times opioids were used per week for a given visit based on the TimeLine Follow Back (TLFB) for the prior week collected at that visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 3
|
2.4 Ave Num of Times Opioids Were Used/Week
Standard Deviation 5.57
|
2.8 Ave Num of Times Opioids Were Used/Week
Standard Deviation 6.66
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 6
|
3.2 Ave Num of Times Opioids Were Used/Week
Standard Deviation 7.69
|
4.0 Ave Num of Times Opioids Were Used/Week
Standard Deviation 8.46
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 10
|
3.2 Ave Num of Times Opioids Were Used/Week
Standard Deviation 9.72
|
2.8 Ave Num of Times Opioids Were Used/Week
Standard Deviation 5.51
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 20
|
3.6 Ave Num of Times Opioids Were Used/Week
Standard Deviation 11.35
|
2.3 Ave Num of Times Opioids Were Used/Week
Standard Deviation 5.34
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 34
|
3.1 Ave Num of Times Opioids Were Used/Week
Standard Deviation 9.21
|
3.2 Ave Num of Times Opioids Were Used/Week
Standard Deviation 10.36
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 38/End of Treatment
|
2.8 Ave Num of Times Opioids Were Used/Week
Standard Deviation 8.94
|
2.4 Ave Num of Times Opioids Were Used/Week
Standard Deviation 8.71
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Screening
|
41.4 Ave Num of Times Opioids Were Used/Week
Standard Deviation 32.08
|
44.9 Ave Num of Times Opioids Were Used/Week
Standard Deviation 40.89
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 1 Day 1
|
26.3 Ave Num of Times Opioids Were Used/Week
Standard Deviation 25.52
|
23.7 Ave Num of Times Opioids Were Used/Week
Standard Deviation 26.90
|
|
Maintenance Phase: Average Number of Times Opioids Were Used Per Week by Visit
Week 2
|
3.9 Ave Num of Times Opioids Were Used/Week
Standard Deviation 9.58
|
4.6 Ave Num of Times Opioids Were Used/Week
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: Baseline to Week 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
The change in participants' number of times opioids were used per week from randomization baseline to each visit based on the 7 daily TimeLine Follow Back (TLFB) for the prior week collected at that visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 6
|
-91.3 % Change from Screening
Standard Deviation 18.91
|
-90.6 % Change from Screening
Standard Deviation 18.63
|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 10
|
-92.9 % Change from Screening
Standard Deviation 18.67
|
-91.1 % Change from Screening
Standard Deviation 17.12
|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 20
|
-92.4 % Change from Screening
Standard Deviation 17.03
|
-93.2 % Change from Screening
Standard Deviation 15.46
|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 34
|
-93.5 % Change from Screening
Standard Deviation 17.59
|
-88.9 % Change from Screening
Standard Deviation 46.94
|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 38/End of Treatment
|
-93.6 % Change from Screening
Standard Deviation 16.51
|
-92.5 % Change from Screening
Standard Deviation 24.89
|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 1 Day 1
|
-30.7 % Change from Screening
Standard Deviation 63.88
|
-40.4 % Change from Screening
Standard Deviation 52.63
|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 2
|
-88.4 % Change from Screening
Standard Deviation 25.81
|
-88.6 % Change from Screening
Standard Deviation 26.09
|
|
Maintenance Phase: Change From Baseline in Number of Times Opioids Were Used Per Week
Week 3
|
-94.3 % Change from Screening
Standard Deviation 13.18
|
-92.5 % Change from Screening
Standard Deviation 19.00
|
SECONDARY outcome
Timeframe: Baseline to Week 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Screening
|
0 Participants
|
0 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 1 Day 1
|
11 Participants
|
14 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 2
|
40 Participants
|
51 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 3
|
56 Participants
|
66 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 6
|
67 Participants
|
65 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 10
|
73 Participants
|
77 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 20
|
67 Participants
|
65 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 34
|
57 Participants
|
68 Participants
|
|
Maintenance Phase: Percentage of Participants Who Were Opioid Abstinent by Visit
Week 38/End of Treatment
|
63 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 38Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
The average number of days opioids were used per week out of days assessed, based on the TimeLine Follow Back (TLFB) for the prior week of each visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Screening
|
6.7 Average Number of Days
Standard Deviation 0.97
|
6.9 Average Number of Days
Standard Deviation 0.57
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 1 Day 1
|
5.1 Average Number of Days
Standard Deviation 2.52
|
4.9 Average Number of Days
Standard Deviation 2.60
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 2
|
1.7 Average Number of Days
Standard Deviation 2.18
|
1.7 Average Number of Days
Standard Deviation 2.15
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 3
|
1.3 Average Number of Days
Standard Deviation 1.94
|
1.2 Average Number of Days
Standard Deviation 1.94
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 6
|
1.6 Average Number of Days
Standard Deviation 2.18
|
1.4 Average Number of Days
Standard Deviation 2.13
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 10
|
1.3 Average Number of Days
Standard Deviation 2.07
|
1.3 Average Number of Days
Standard Deviation 2.14
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 20
|
1.3 Average Number of Days
Standard Deviation 2.21
|
1.0 Average Number of Days
Standard Deviation 1.85
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 34
|
1.2 Average Number of Days
Standard Deviation 2.21
|
0.9 Average Number of Days
Standard Deviation 1.98
|
|
Maintenance Phase: Average Number of Days Opioids Were Used Per Week by Visit
Week 38/End of Treatment
|
1.2 Average Number of Days
Standard Deviation 2.24
|
0.9 Average Number of Days
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Up to 288 days after randomization (accounting for out-of-window visits)Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
Treatment retention is defined as the number of days that participants remained in the treatment from randomization in the Maintenance Phase of the study until the date of the last observed study visit. The treatment retention since DB randomization is estimated using Kaplan-Meier method. The event is prematurely discontinuing the study prior to Week 38/EOT Visit.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Time From DB Randomization to Last Observed Study Visit (Treatment Retention)
|
266 Days
Interval 241.0 to
NA Explanation: the 95% upper confidence limit for the median is not estimable by the Kaplan-Meier method because the curve representing the upper confidence intervals for the survivor function lies above 0.50.
|
260 Days
Interval 113.0 to
NA Explanation: the 95% upper confidence limit for the median is not estimable by the Kaplan-Meier method because the curve representing the upper confidence intervals for the survivor function lies above 0.50.
|
SECONDARY outcome
Timeframe: Week 34Population: Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses.
The proportion of randomized participants who completed the last scheduled injection of RBP-6000 at Week 34 were summarized using observed data. Missing data were not applicable for this endpoint.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=216 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Maintenance Phase: Percentage of Participants Who Complete the Last Scheduled Injection
|
138 Participants
|
140 Participants
|
SECONDARY outcome
Timeframe: 35 daysPopulation: Evaluable Population for Treatment Retention/Discontinuation: For analysis pertaining to treatment retention and time to treatment discontinuation, the Substudy Full Analysis Set participants who discontinued treatment due to not meeting inclusion/exclusion criteria were also excluded. The participants were analyzed corresponding to the induction arm they received ("as treated", ie, actual arm).
Percentage of participants retained at 5 weeks after the first dose of TM buprenorphine was estimated using the Kaplan-Meier product limit method.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=470 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=253 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Induction Phase: Percentage of Participants Retained at 5 Weeks
|
60.2 Percentage of participants
Interval 55.6 to 64.5
|
53.4 Percentage of participants
Interval 47.0 to 59.3
|
SECONDARY outcome
Timeframe: Up to approximately 2 weeksPopulation: Substudy Full Analysis Set (SFAS): All participants randomized to open-label substudy treatment, received the first dose of TM BUP, and did not demonstrate idiosyncratic response to the first dose of TM BUP (ie, allergic / hypersensitivity reaction). Participants were analyzed corresponding to the induction arm they received ("as treated", ie, actual arm).
These endpoints encompassed all induction attempts and therefore utilized the first dose of transmucosal buprenorphine (TM BUP) for derivations. A treatment-emergent adverse event (TEAE) was defined as an AE having an onset date/time after administration of the first TM BUP dose and before the date/time of Injection 3. TEAEs up to RBP-6000 Injection 2 were TEAEs with a start date/time on or after the first dose of TM BUP and before the date/time of Injection 2.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=474 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=255 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Induction Phase: Number of Participants With Adverse Events up to Injection 2
|
202 Participants
|
93 Participants
|
SECONDARY outcome
Timeframe: Approximately 4 weeksPopulation: Substudy Full Analysis Set (SFAS): All participants randomized to open-label substudy treatment, received the first dose of TM BUP, and did not demonstrate idiosyncratic response to the first dose of TM BUP (ie, allergic / hypersensitivity reaction). Participants were analyzed corresponding to the induction arm they received ("as treated", ie, actual arm). For this analysis, only SFAS participants who received Injection 2 were included.
These endpoints encompassed all induction attempts and therefore utilized the first dose of transmucosal buprenorphine (TM BUP) for derivations. A treatment-emergent adverse event (TEAE) was defined as an AE having an onset date/time after administration of the first TM BUP dose and before the date/time of Injection 3. TEAEs between RBP-6000 Injections 2 and 3 were TEAEs with a start date/time on or after Injection 2 and before the date/time of Injection 3.
Outcome measures
| Measure |
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=314 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=138 Participants
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|
|
Induction Phase: Number of Participants With Adverse Events Between Injections 2 and 3
|
86 Participants
|
29 Participants
|
Adverse Events
Induction Phase: Rapid Induction
Serious events: 7 serious events
Other events: 135 other events
Deaths: 1 deaths
Induction Phase: Standard of Care Induction
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
Maintenance Phase: Extended-release Buprenorphine 100 mg
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
Maintenance Phase: Extended-release Buprenorphine 300 mg
Serious events: 11 serious events
Other events: 30 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Induction Phase: Rapid Induction
n=474 participants at risk
Participants will receive 4 mg transmucosal buprenorphine on Day 1. Participants meeting eligibility requirements will then receive 300 mg extended-release buprenorphine by subcutaneous injection at least 1 hour later and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Induction Phase: Standard of Care Induction
n=255 participants at risk
Participants will receive transmucosal buprenorphine for a minimum of 7 days per applicable product labelling information. Participants meeting eligibility requirements will receive 300 mg extended-release buprenorphine by subcutaneous injection on Day 1 and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 participants at risk
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=217 participants at risk
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|---|---|
|
Nervous system disorders
Sedation
|
0.21%
1/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Nervous system disorders
Seizure
|
0.21%
1/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Nervous system disorders
Syncope
|
0.21%
1/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
General disorders
Drug withdrawal syndrome
|
0.42%
2/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Gastrointestinal disorders
Nausea
|
0.21%
1/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
1/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.39%
1/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Infections and infestations
Skin infection
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.39%
1/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.21%
1/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Infections and infestations
Wound infection
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.92%
2/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.46%
1/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
Other adverse events
| Measure |
Induction Phase: Rapid Induction
n=474 participants at risk
Participants will receive 4 mg transmucosal buprenorphine on Day 1. Participants meeting eligibility requirements will then receive 300 mg extended-release buprenorphine by subcutaneous injection at least 1 hour later and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Induction Phase: Standard of Care Induction
n=255 participants at risk
Participants will receive transmucosal buprenorphine for a minimum of 7 days per applicable product labelling information. Participants meeting eligibility requirements will receive 300 mg extended-release buprenorphine by subcutaneous injection on Day 1 and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).
Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 100 mg
n=218 participants at risk
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
Maintenance Phase: Extended-release Buprenorphine 300 mg
n=217 participants at risk
Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.
Extended-release Buprenorphine: Administered by subcutaneous injection
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.7%
65/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
12.2%
31/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
1.8%
4/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
6.0%
13/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Psychiatric disorders
Anxiety
|
10.5%
50/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
8.2%
21/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Psychiatric disorders
Restlessness
|
7.0%
33/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
5.5%
14/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.5%
26/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
4.3%
11/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
General disorders
Injection site erythema
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
2.8%
6/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
5.1%
11/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
|
General disorders
Injection site pain
|
0.00%
0/474 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
0.00%
0/255 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
1.4%
3/218 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
5.1%
11/217 • Approximately 38 weeks
Investigator or designee was responsible for identifying, documenting, and reporting events that met the AE definition. The Open-label Induction Substudy (OLIS) and main study were reported separately (ie, Induction \[Rapid Induction vs Standard of Care Induction\] and Maintenance \[100 mg vs 300 mg\]). Induction Phase (OLIS) used MedDRA 26.1 and Double-blind Treatment Phase (Injection 3 through the end of the study) used MedDRA 27.0. SAEs were not subtracted from other AEs for "Other" AE table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator will not disseminate, present or publish any of the study data without the prior written approval from Indivior to do so.
- Publication restrictions are in place
Restriction type: OTHER