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 |
|---|---|---|---|---|---|---|---|---|
| Intervention Food Pantries and Clients | Food pantries will transform to offer healthier and more appealing food; the effect on clients will be measured; Intervention Food Pantries: Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors; Intervention Clients: Clients who use and were recruited at intervention food pantries. | 1 | None | 0 | 158 | 0 | 158 | View |
| Control Food Pantries and Clients | Food pantries will make no changes during the evaluation period; the effect on clients will be measured; Control Food Pantries: Normal food pantry operations during the evaluation period; Control Clients: Clients who use and were recruited at control food pantries. | 1 | None | 0 | 159 | 0 | 159 | View |