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 |
|---|---|---|---|---|---|---|---|---|
| Self-Monitoring and Feedback | The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. On weeks two, four, and six subjects will receive personalized health feedback based on the PPG device data and sleep diaries. Behavioral Self-Management and Feedback: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, active self-monitoring of health and behavior using daily diaries, and the provision of personalized health feedback and advice. | 0 | None | 0 | 30 | 0 | 30 | View |
| Self-Monitoring | The intervention consists of subjects wearing a PPG device for 6 weeks. Subjects will monitor their own health and report their sleep behaviors daily during this time. Behavioral Self-Management: Self-management brief health intervention that involves passive daily health monitoring using a PPG sensor, and active self-monitoring of health and behavior using daily diaries. | 0 | None | 0 | 30 | 0 | 30 | View |