Trial Outcomes & Findings for Buprenorphine for Prisoners (NCT NCT00574067)
NCT ID: NCT00574067
Last Updated: 2018-08-29
Results Overview
mean days used heroin during the past 30 days
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
213 participants
Primary outcome timeframe
1 year
Results posted on
2018-08-29
Participant Flow
Participant milestones
| Measure |
Bup+OTP
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
54
|
53
|
|
Overall Study
COMPLETED
|
52
|
52
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buprenorphine for Prisoners
Baseline characteristics by cohort
| Measure |
B+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
B+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
C+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
C+CHC
n=53 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.15 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
39.18 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
39.55 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
38.42 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
39.08 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearmean days used heroin during the past 30 days
Outcome measures
| Measure |
Bup+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
n=53 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
Number of Days of Heroin Use
|
6.0 days
Standard Deviation 11.4
|
6.4 days
Standard Deviation 11.5
|
6.5 days
Standard Deviation 11.3
|
4.0 days
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: 1 yearentered community treatment within 10 days of release from prison (yes vs. no)
Outcome measures
| Measure |
Bup+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
n=53 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
Drug Abuse Treatment Entry and Retention in the Community
|
22 participants
|
26 participants
|
23 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 1 yearNumber of days used cocaine during the past 30 days.
Outcome measures
| Measure |
Bup+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
n=51 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
Number of Days of Cocaine Use
|
1.1 days
Standard Deviation 4.3
|
4.1 days
Standard Deviation 9.5
|
4.7 days
Standard Deviation 9.4
|
2.7 days
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 1 yearDays of crime during the past 30 days
Outcome measures
| Measure |
Bup+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
n=51 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
Criminal Activity
|
3.4 days
Standard Deviation 9.4
|
5.4 days
Standard Deviation 11.4
|
3.3 days
Standard Deviation 9.2
|
3.2 days
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 1 yearNumber of days employed during the past year
Outcome measures
| Measure |
Bup+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
n=53 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
Employment Status
|
30.0 days
Standard Deviation 28.1
|
29.6 days
Standard Deviation 26.9
|
22.3 days
Standard Deviation 32.4
|
31.4 days
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: 1 yearNumber of times shared a needle during the past year
Outcome measures
| Measure |
Bup+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
n=53 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
HIV Risk Behavior Needle Sharing
|
2.9 times
Standard Deviation 15.9
|
.1 times
Standard Deviation .5
|
2.1 times
Standard Deviation 13.6
|
.1 times
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 1 yearNumber of times had sex without using a condom during the past year
Outcome measures
| Measure |
Bup+OTP
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
Bup+CHC
n=52 Participants
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+OTP
n=54 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
Counseling+CHC
n=53 Participants
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
HIV Risk Behavior
|
59.7 times
Standard Deviation 52.6
|
36.1 times
Standard Deviation 40.3
|
33.3 times
Standard Deviation 29.3
|
50.4 times
Standard Deviation 38.4
|
Adverse Events
B+OTP
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
B+CHC
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
C+OTP
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
C+CHC
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B+OTP
n=52 participants at risk
Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
|
B+CHC
n=52 participants at risk
Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
C+OTP
n=54 participants at risk
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
C+CHC
n=53 participants at risk
Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
|
|---|---|---|---|---|
|
Investigations
shoulder pain
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy compplications
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Infections and infestations
pneumonia
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
5.6%
3/54 • Number of events 3
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
3.7%
2/54 • Number of events 2
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
3.8%
2/53 • Number of events 2
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
General disorders
ulcer
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/54 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Injury, poisoning and procedural complications
allergic reaction
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/54 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Gastrointestinal disorders
gallstones
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/54 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Surgical and medical procedures
hysterectomy
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/54 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Blood and lymphatic system disorders
cellulitis in right arm and leg
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Investigations
osteomyelitis and soft tissue infection of the cervical spine
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
General disorders
seizure
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Infections and infestations
meningitis
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy complications
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Gastrointestinal disorders
constipation
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
—
0/0
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Injury, poisoning and procedural complications
back injury
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Investigations
swollen foot
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/54 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Investigations
unkown
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
3.8%
2/52 • Number of events 2
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Psychiatric disorders
depression
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Infections and infestations
kidney problem
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
3.8%
2/52 • Number of events 2
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/53 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Investigations
physical assualt
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Blood and lymphatic system disorders
blood clot
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Infections and infestations
influenza
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Investigations
alcohol withdrawal
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Cardiac disorders
chest pain
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Pregnancy, puerperium and perinatal conditions
cesarean birth
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
|
Investigations
neck pain
|
0.00%
0/52
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
1.9%
1/52 • Number of events 1
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/54
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
0.00%
0/53
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place