Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
NCT ID:
NCT00574067
Description:
0 represents other \[non-serious\] adverse events were not collected/assessed during the 12-months post-release time period.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00574067
Study Brief:
Buprenorphine for Prisoners
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| B+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 | None | None | 4 | 52 | 0 | 0 | View |
| B+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. | None | None | 14 | 52 | 0 | 0 | View |
| C+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. | None | None | 10 | 53 | 0 | 0 | View |
| C+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. | None | None | 10 | 54 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| back injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| swollen foot | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| unkown | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| kidney problem | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| blood clot | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| chest pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| cesarean birth | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| neck pain | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| shoulder pain | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| pregnancy compplications | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| allergic reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| hysterectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| cellulitis in right arm and leg | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| osteomyelitis and soft tissue infection of the cervical spine | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| seizure | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| pregnancy complications | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
| physical assualt | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| alcohol withdrawal | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| ulcer | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| gallstones | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
Other Events(If Any):