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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Experimental | Subjects randomized to the experimental arm will be assigned to a recovery coach.In addition to being linked to a community buprenorphine or methadone treatment program, the recovery coach will work to meet weekly with the subject following discharge from the hospital to provide support. Recovery coach: The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion. | 0 | None | 6 | 13 | 0 | 13 | View |
| Control | Subjects randomized to the control arm will receive treatment as usual. This means subjects are linked to ongoing outpatient treatment with buprenorphine or methadone. | 1 | None | 7 | 12 | 0 | 12 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalization - acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hospitalization - bacteremia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalization - opioid overdose | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalization - abdominal bleed | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hospitalization - infected total knee replacement | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hospitalization - surgical fixation status post osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hospitalization - cellulitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Hospitalization - splenic rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hospitalization - endocarditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| hospitalization - acute on chronic back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| hospitalization - abdominal pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| hospitalization - spinal epidural abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| hospitalization - substance-induced psychosis | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| hospitalization - suicidal ideation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| hospitalization - septic arthritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| hospitalization - acute on chronic congestive heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |