Trial Outcomes & Findings for Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (NCT NCT02617628)
NCT ID: NCT02617628
Last Updated: 2021-01-28
Results Overview
Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
146 participants
Primary outcome timeframe
12 weeks (month 3)
Results posted on
2021-01-28
Participant Flow
Recruitment started August 2016 and ended June 16, 2018 in the Philadelphia Prison System. Subjects all were recruited while incarcerated.
Subjects were stratified to sentenced/not sentenced and male/female
Participant milestones
| Measure |
Before Re-entry
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
|
After Re-entry
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
72
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
62
|
61
|
Reasons for withdrawal
| Measure |
Before Re-entry
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
|
After Re-entry
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
|
|---|---|---|
|
Overall Study
Withdr, Transfers-other prisons, dropout
|
62
|
61
|
Baseline Characteristics
Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
Baseline characteristics by cohort
| Measure |
After Re-entry
n=74 Participants
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone after they were released from prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
|
Before Re-entry
n=72 Participants
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they left the prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.0 • n=99 Participants
|
36.2 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
37.0 years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=99 Participants
|
72 participants
n=107 Participants
|
146 participants
n=206 Participants
|
|
Opioid Drug Use
|
74 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
EuroQol Overall Health
Mobility · No Problems
|
69 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
EuroQol Overall Health
Mobility · Slight Problems
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
EuroQol Overall Health
Mobility · Moderate Problems
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
EuroQol Overall Health
Mobility · Severe Problems
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
EuroQol Overall Health
Mobility · x=Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
EuroQol Overall Health
Self Care · No Problems
|
71 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
EuroQol Overall Health
Self Care · Slight Problems
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
EuroQol Overall Health
Self Care · Moderate Problems
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
EuroQol Overall Health
Self Care · Severe Problems
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
EuroQol Overall Health
Self Care · x=Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
EuroQol Overall Health
Doing Usual Activities · No Problems
|
65 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
EuroQol Overall Health
Doing Usual Activities · Slight Problems
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
EuroQol Overall Health
Doing Usual Activities · Moderate Problems
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
EuroQol Overall Health
Doing Usual Activities · Severe Problems
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
EuroQol Overall Health
Doing Usual Activities · x=Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
EuroQol Overall Health
Pain or Discomfort · No Problems
|
42 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
EuroQol Overall Health
Pain or Discomfort · Slight Problems
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
EuroQol Overall Health
Pain or Discomfort · Moderate Problems
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
EuroQol Overall Health
Pain or Discomfort · Severe Problems
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
EuroQol Overall Health
Pain or Discomfort · x=Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
EuroQol Overall Health
Anxiety and Depression · No Problems
|
18 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
EuroQol Overall Health
Anxiety and Depression · Slight Problems
|
27 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
EuroQol Overall Health
Anxiety and Depression · Moderate Problems
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
EuroQol Overall Health
Anxiety and Depression · Severe Problems
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
EuroQol Overall Health
Anxiety and Depression · x=Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Beck Depression Index
No Depression
|
44 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Beck Depression Index
Clinical Depression
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Beck Depression Index
Missing
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Timeline Follow-Back
Heroin Use
|
21.91 days
STANDARD_DEVIATION 12.6 • n=99 Participants
|
25.56 days
STANDARD_DEVIATION 9.59 • n=107 Participants
|
23.71 days
STANDARD_DEVIATION 11.3 • n=206 Participants
|
|
Timeline Follow-Back
Methadone Use
|
.92 days
STANDARD_DEVIATION 4.7 • n=99 Participants
|
1.19 days
STANDARD_DEVIATION 4.9 • n=107 Participants
|
1.05 days
STANDARD_DEVIATION 4.7 • n=206 Participants
|
|
Timeline Follow-Back
Other Opioids
|
8.46 days
STANDARD_DEVIATION 12.05 • n=99 Participants
|
6.97 days
STANDARD_DEVIATION 11.06 • n=107 Participants
|
7.73 days
STANDARD_DEVIATION 11.56 • n=206 Participants
|
|
Timeline Follow-Back
Benzodiazepines
|
6.36 days
STANDARD_DEVIATION 10.59 • n=99 Participants
|
7.78 days
STANDARD_DEVIATION 11.11 • n=107 Participants
|
7.06 days
STANDARD_DEVIATION 10.84 • n=206 Participants
|
|
Timeline Follow-Back
Cocaine
|
12.7 days
STANDARD_DEVIATION 13.01 • n=99 Participants
|
14.19 days
STANDARD_DEVIATION 13.27 • n=107 Participants
|
13.44 days
STANDARD_DEVIATION 13.11 • n=206 Participants
|
|
Risk Assessment Battery
Drug Risk Score
|
3.19 units on a scale
STANDARD_DEVIATION 4.33 • n=99 Participants
|
4.42 units on a scale
STANDARD_DEVIATION 4.87 • n=107 Participants
|
3.79 units on a scale
STANDARD_DEVIATION 4.6 • n=206 Participants
|
|
Risk Assessment Battery
Sex Risk Scoe
|
5.61 units on a scale
STANDARD_DEVIATION 2.89 • n=99 Participants
|
5.94 units on a scale
STANDARD_DEVIATION 2.66 • n=107 Participants
|
5.77 units on a scale
STANDARD_DEVIATION 2.77 • n=206 Participants
|
|
Risk Assessment Battery
Total RAB Score
|
8.80 units on a scale
STANDARD_DEVIATION 6.17 • n=99 Participants
|
10.36 units on a scale
STANDARD_DEVIATION 6.68 • n=107 Participants
|
9.57 units on a scale
STANDARD_DEVIATION 6.45 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (month 3)Population: In treatment arm 1 (before reentry) 38 subjects received vivitrol before leaving prison. In treatment arm 2 (after reentry) 48 subjects were eligible to receive injections after release from prison. Arm 2 subjects were to return to the research clinic within 7 days after release to receive their first injection.
Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.
Outcome measures
| Measure |
Before Re-entry
n=38 Participants
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
|
After Re-entry
n=48 Participants
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), After they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
|
|---|---|---|
|
Relapse to Opioid Use in Subjects by Month 3
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 0 to 28 monthsPopulation: This outcome was determined as follows: one XR-NTX injection provided 4 weeks of treatment. Study patients also had counseling, thus weeks in treatment equaled the weeks of protected time from XR-NTX plus the number of weeks a patient had one or more counseling appointments after the protection from the last XR-NTX dose ended.
percentage of patients who were reincarcerated
Outcome measures
| Measure |
Before Re-entry
n=38 Participants
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
|
After Re-entry
n=48 Participants
Extended Release Naltrexone, 380 mg injection
Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), After they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.
outpatient treatment for six months. Subjects also received weekly psychosocial counseling.
|
|---|---|---|
|
Reincarceration
|
28 Participants
|
22 Participants
|
Adverse Events
Before Re-entry
Serious events: 10 serious events
Other events: 35 other events
Deaths: 1 deaths
After Re-entry
Serious events: 13 serious events
Other events: 21 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Before Re-entry
n=74 participants at risk
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
|
After Re-entry
n=72 participants at risk
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
overdose
|
9.5%
7/74 • Number of events 7 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
12.5%
9/72 • Number of events 9 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
abdominal pain
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Renal and urinary disorders
kidney pain
|
2.7%
2/74 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
panic attack
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
broken rib
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
Other adverse events
| Measure |
Before Re-entry
n=74 participants at risk
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
|
After Re-entry
n=72 participants at risk
Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months
Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
anxiety
|
8.1%
6/74 • Number of events 6 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
4.2%
3/72 • Number of events 3 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
anxiousness
|
6.8%
5/74 • Number of events 5 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.4%
4/74 • Number of events 5 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
back pain-lower
|
1.4%
1/74 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
General disorders
nose bleed
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Eye disorders
blurry vision
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
achey joints
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Eye disorders
allergy in left eye
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
arthritis in leg
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
body aches
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Cardiac disorders
chest pain-cardiac
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Respiratory, thoracic and mediastinal disorders
common cold
|
5.4%
4/74 • Number of events 4 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
2.8%
2/72 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
depression
|
6.8%
5/74 • Number of events 7 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
2.8%
2/72 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
General disorders
injection site reaction
|
10.8%
8/74 • Number of events 12 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
5.6%
4/72 • Number of events 5 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Immune system disorders
malaise
|
2.7%
2/74 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
5.6%
4/72 • Number of events 4 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
diarrhea
|
4.1%
3/74 • Number of events 3 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Nervous system disorders
headache
|
8.1%
6/74 • Number of events 6 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
4.2%
3/72 • Number of events 3 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
toothache
|
8.1%
6/74 • Number of events 8 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Respiratory, thoracic and mediastinal disorders
breathing problems
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Renal and urinary disorders
urinary tract infection
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
2.8%
2/72 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Injury, poisoning and procedural complications
wrist pain
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
nausea
|
4.1%
3/74 • Number of events 3 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
nausea with vomiting
|
2.7%
2/74 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Immune system disorders
flu like symptoms
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
2.8%
2/72 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Infections and infestations
eye infection
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
dry mouth
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
2.8%
2/72 • Number of events 2 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Reproductive system and breast disorders
decreased sex drive
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Reproductive system and breast disorders
fibrois mass on ovary
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Renal and urinary disorders
increased urine
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
hip and left femor ache
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Infections and infestations
infected boil
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
heart burn
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
insomnia
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Immune system disorders
insect bite swelling
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Injury, poisoning and procedural complications
accidental inury, arm and knuckle
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Nervous system disorders
dizziness
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
General disorders
excessive sweating
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
withdrawn feeling
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
foot pain
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
General disorders
hernia pain
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
hip arthrosis
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
General disorders
hot-cold sweats
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Psychiatric disorders
irritable
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
General disorders
lethargic
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Pregnancy, puerperium and perinatal conditions
miscarriage of pregnancy
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
muscle ache
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
2.8%
2/72 • Number of events 3 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Nervous system disorders
restless
|
0.00%
0/74 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
1.4%
1/72 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Respiratory, thoracic and mediastinal disorders
runny nose
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Respiratory, thoracic and mediastinal disorders
breathing abnormality
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Gastrointestinal disorders
sore throat
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
|
Surgical and medical procedures
tooth extraction
|
1.4%
1/74 • Number of events 1 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
0.00%
0/72 • 2 years, 2 months
The definition is the same as clinicaltrials.gov. Collection: Medical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.
|
Additional Information
W. Stuart Watson
University of Pennsylvania Office of Research Services
Phone: 215-573-6707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place