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 |
|---|---|---|---|---|---|---|---|---|
| Control | Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention Individual evidence-based STI/HIV prevention intervention: Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use. | 0 | None | 0 | 33 | 0 | 33 | View |
| Intervention | Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner Intervention: Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male). | 0 | None | 0 | 33 | 0 | 33 | View |