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 |
|---|---|---|---|---|---|---|---|---|
| Arm 1: Experimental | The COMPASS (Community Participation through Self-Efficacy Skills Development) program aims at developing and testing a novel patient-centered intervention framework that can be utilized as a platform for VA community re-integration comparative effectiveness research. Experimental - COMPASS: Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks. | 0 | None | 0 | 40 | 0 | 40 | View |
| Arm 1: Control | Fifty-five participants in the supported discharge, or control, group will not receive the intervention, but will receive phone calls to answer a short questionnaire and check in on their status. Control Control - COMPASS: Increased hours of patient-provider interactions Group. | 0 | None | 0 | 51 | 0 | 51 | View |