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 |
|---|---|---|---|---|---|---|---|---|
| Provider Training Group | Participants received a three-part training on addressing medical mistrust and intersectional stigma in HIV care. The training included a 1-hour recorded module, a 2-hour live role-play session, and a self-paced workbook. Content focused on using validation and motivational interviewing strategies to improve provider communication. | 0 | None | 0 | 29 | 0 | 29 | View |
| Control Group | Participants in the control group did not receive any training during the study period. They completed the same baseline, post, and follow-up assessments as the intervention group for comparison purposes. | 0 | None | 0 | 30 | 0 | 30 | View |