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 Group: Social Cognition Interaction Training | First period of Intervention Group, social cognition interaction training from 0 -6 months. | 0 | None | 2 | 25 | 0 | 25 | View |
| Intervention Group: Treatment As Usual | Second period of Intervention Group, treatment as usual after 6 months. | 0 | None | 0 | 25 | 0 | 25 | View |
| Waitlist Control Group, Treatment As Usual | First period of Waitlist Control Group, treatment as usual from 0 - 6 months. | 0 | None | 1 | 26 | 0 | 26 | View |
| Waitlist Control Group, Social Cognition Interaction Training | Second period of Waitlist Control Group, social cognition interaction training after 6 months. | 0 | None | 0 | 26 | 0 | 26 | View |