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 |
|---|---|---|---|---|---|---|---|---|
| Immediate Treatment | Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention. | None | None | 0 | 4 | 0 | 4 | View |
| Delayed Treatment | Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention. | None | None | 0 | 4 | 0 | 4 | View |