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 |
|---|---|---|---|---|---|---|---|---|
| Waitlist-Control | Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed. | None | None | 0 | 165 | 0 | 165 | View |
| Common Elements Treatment Approach | Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors. Common Elements Treatment Approach: CETA components include: 1. Engagement (encouraging participation) 2. Psychoeducation (introduction) 3. Anxiety Management Strategies (relaxation) 4. Behavioral Activation (getting active) 5. Cognitive Coping/Restructuring (thinking in a different way, part I and part II) 6. Imaginal Gradual Exposure (talking about difficult memories) 7. In Vivo Exposure (Live exposure) 8. Suicide/Homicide/Danger Assessment and Planning (safety) 9. Screening and Brief Intervention for Alcohol (alcohol intervention) | None | None | 0 | 182 | 0 | 182 | View |