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 |
|---|---|---|---|---|---|---|---|---|
| Omeprazole (Suspension) | Open-label, with all subjects receiving omeprazole Omeprazole (suspension): 1 mg/kg/day | 0 | None | 0 | 3 | 0 | 3 | View |
| Lifestyle Modification | Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.) Lifestyle Modification: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed | 0 | None | 0 | 4 | 0 | 4 | View |