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 |
|---|---|---|---|---|---|---|---|---|
| Healthy Volunteer Pre-vaccination | Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine | None | None | 0 | 21 | 0 | 21 | View |
| Healthy Volunteer Post-vaccination | Healthy volunteers who had blood drawn after vaccination with influenza vaccine | None | None | 0 | 21 | 0 | 21 | View |
| Azathioprine Pre-vaccination | Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine | None | None | 0 | 10 | 0 | 10 | View |
| Azathioprine Post-vaccination | Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine | None | None | 0 | 10 | 0 | 10 | View |
| TNF Alpha Blocker Pre-vaccination | Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine | None | None | 0 | 12 | 0 | 12 | View |
| TNF Alpha Blocker Post-vaccination | Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine | None | None | 0 | 12 | 0 | 12 | View |