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 |
|---|---|---|---|---|---|---|---|---|
| Fixed Dose Combination (FDC) | 12.5 mg Empagliflozin / 500mg metformin fixed dose combination Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin | None | None | 0 | 32 | 11 | 32 | View |
| Separate Tablets | Empagliflozin and Metformin tablets Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet Empagliflozin 10 mg: Empagliflozin 10 mg tablet Metformin 500 mg: Metformin 500 mg tablet | None | None | 0 | 30 | 5 | 30 | View |