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 |
|---|---|---|---|---|---|---|---|---|
| Prosthetic Foot Intervention | Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN) Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button Conventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual Commercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals | 0 | None | 0 | 6 | 0 | 6 | View |