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 |
|---|---|---|---|---|---|---|---|---|
| Experimental: Self Testing Kit | This group will be provided a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will also be provided 5 referral cards to give to their partners and peers in the drug, sex, and social networks for them to request a free HIV self-testing kit from the "I Want The Kit" website. | 0 | None | 0 | 102 | 0 | 102 | View |
| No Intervention: No Self Testing Kit | This group will not receive a free Food and Drug Administration-approved HIV self-testing home kit (OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test). Participants in this group will not receive referral cards for their partners or peers for them to request a free HIV self-testing kit from the "I Want The Kit" website. | 0 | None | 0 | 98 | 0 | 98 | View |