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 |
|---|---|---|---|---|---|---|---|---|
| Raltegravir | Raltegravir in combination with truvada (tenofovir and emtricitabine) Raltegravir and truvada: Raltegravir 400 mg po bid, truvada 1 tab q daily | None | None | 1 | 14 | 0 | 0 | View |
| Atazanavir | Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Atazanavir, Norvir and Truvada: Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily | None | None | 0 | 14 | 0 | 0 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MAI infection, multi-organ failure, death | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |