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 |
|---|---|---|---|---|---|---|---|---|
| Dapagliflozin | 10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks. Dapagliflozin 10 mg: 10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth | 0 | None | 0 | 10 | 0 | 10 | View |
| Nutritional Counseling | 10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks Nutritional counseling: 10 participants randomized to receive 12 weeks of weekly counseling on nutrition | 0 | None | 0 | 10 | 0 | 10 | View |