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 |
|---|---|---|---|---|---|---|---|---|
| AllyQuest Pilot | The research assistant (RA) will meet with participants in person to explain the study in detail, facilitate app download and login onto participants' phones, and provide an app site tour to highlight features. Participants will complete a baseline demographic and risk assessment administered via a computer assisted survey instrument (CASI). At the end of the one-month field trial, participants will undergo a debriefing session to evaluate their experience using the app, overall satisfaction and any problems they encountered. AllyQuest: AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis. | 0 | None | 0 | 20 | 0 | 20 | View |