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 |
|---|---|---|---|---|---|---|---|---|
| PTSD Neurofeedback | Following assessment for eligibility and safety, study participants view an audiovisual stimulus called Bravemind, a virtual-world environment for military members simulating Iraq and Afghanistan. The interaction involves passive view of a virtual town with an appearance similar to those found in Iraq and Afghanistan. Events occur in the stimulus designed to evoke stress, such as smoke, explosions, and/or the appearance of enemy combatants. While viewing this environment, study participants are undergoing an fMRI scan and rating their level of stress on a 1-8 scale. There is no control group for this study. | 0 | None | 0 | 14 | 0 | 14 | View |