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 |
|---|---|---|---|---|---|---|---|---|
| Jawbone/Withings Sleep Trackers, Bodymedia Sensewear | 2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient | 0 | None | 0 | 22 | 0 | 22 | View |