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 |
|---|---|---|---|---|---|---|---|---|
| Alcohol Administration | Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the number of individual participants (both initial contacts and their friends) who received a moderate dose of alcohol (Target BAC .08%). | 0 | None | 0 | 320 | 0 | 320 | View |
| Control Beverage Administration | Primary participants in the current study consisted of both eligible individuals who first contacted the lab and their eligible friends. Here we report the number of individual participants (both initial contacts and their friends) who received a non-alcoholic beverage. | 0 | None | 0 | 320 | 0 | 320 | View |