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 |
|---|---|---|---|---|---|---|---|---|
| Older Adults With Dizziness | Clinical trial only has one arm or participant group. All participants undergo the same experiment. They will perform exercises with the Vestibular Rehabilitation App as well as without the App. The order is randomized. Vestibular rehabilitation app: Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely. | 0 | None | 0 | 40 | 0 | 40 | View |