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 |
|---|---|---|---|---|---|---|---|---|
| SLEEP-E Dyads Intervention | SLEEP-E Dyads Intervention Adaptive prescriptions for the individualized components of the sleep intervention will be written for each dyad based upon dyad-specific risk factors, sources of sleep disturbance, nature of sleep problems and baseline sleep hygiene practices. In addition, each dyad will receive a core intervention component consisting of a sleep hygiene psycho-education curriculum, activity enhancement and relaxation instruction and training delivered by the iPads and two tele-video conferences to discuss evaluation, obtain buy-in for the intervention and provide coaching. There were no adverse events. | 0 | None | 0 | 60 | 0 | 60 | View |
| Wait List Control Group | During the intervention period there is no data collection or contact with research staff other than for scheduling outcomes visits. There were no adverse events. | 0 | None | 0 | 36 | 0 | 36 | View |