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 |
|---|---|---|---|---|---|---|---|---|
| Standard Care | -Standard Care pain medicine/management will be given Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls | 0 | None | 0 | 67 | 0 | 67 | View |
| JACKI® RECOVERY JACKET + Standard Care | * Patient will be encouraged to use the Jacki Recovery Jacket at home * Patient will be taught how to tuck the drainage tubes in the jacket pocket * Patient will be taught how to un-tuck the drainage tubes from jacket pocket * Standard care pain medicine/management will be given Jacki Recovery jacket: An outer jacket that holds surgical drains and allows access for blood draws Standard Care Pain medicine/management: Standard care pain medicine and management in hospitals where the study enrolls | 0 | None | 0 | 72 | 0 | 72 | View |