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 |
|---|---|---|---|---|---|---|---|---|
| Allopurinol | Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days allopurinol | None | None | 1 | 16 | 0 | 16 | View |
| Sugar Pill (Placebo) | Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days. Placebo (sugar pill) | None | None | 2 | 19 | 0 | 19 | View |