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 |
|---|---|---|---|---|---|---|---|---|
| Application of Tourniquets on Lower Extremities | Participants will have their baseline blood pressure measured in their upper extremities followed by application of CAT tourniquets to both lower extremities. Blood pressure will be measured again in the upper extremities once the CAT tourniquets are deployed. This will be repeated 3 times. combat application tourniquets (CAT): CAT tourniquets have been indicated for use in emergency situations revolving around a wounded limb, such as hemorrhage control.22-23 CAT tourniquets are the official tourniquet of the US Army since in 2005. We will deploy well-studied and FDA approved combat application tourniquets (CAT) on both thighs of volunteer healthy adult subjects while measuring blood pressure in the upper extremities. | 0 | None | 0 | 27 | 0 | 27 | View |