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 |
|---|---|---|---|---|---|---|---|---|
| CGM Patients | Apply continuous glucose monitor, calibrate and make glucose measurements. Measurements are blinded to the care provider Continuous Glucose Monitor (CGM): Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care. | 0 | None | 0 | 10 | 0 | 10 | View |