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 |
|---|---|---|---|---|---|---|---|---|
| Pre Post ART | HCV and HIV viral load pre and post antiretroviral therapy Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. raltegravir: HIV medication, 400 mg twice daily by mouth Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth | None | None | 1 | 20 | 0 | 20 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| bleeding | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |