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 |
|---|---|---|---|---|---|---|---|---|
| FLOW Intervention | Sites receive the FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process. FLOW intervention: The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process. | 0 | None | 0 | 0 | 0 | 0 | View |
| Waitlist Until Time 2 | Arm 2: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 2. | 0 | None | 0 | 0 | 0 | 0 | View |
| Waitlist Until Time 3 | Arm 3: In this stepped wedge design, sites will be randomized to receive the FLOW intervention at Time 1, or to be in a waitlist until Time 3. | 0 | None | 0 | 0 | 0 | 0 | View |