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 |
|---|---|---|---|---|---|---|---|---|
| High Dose, Fasted: 1 FDC Tablet | 1 fixed dose combination (FDC) tablet under fasted conditions: 25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet | None | None | 0 | 23 | 4 | 23 | View |
| High Dose, Fasted: 3 Single Tablets | 3 single tablets under fasted conditions: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets | None | None | 0 | 23 | 1 | 23 | View |
| High Dose, Fed: 1 FDC Tablet | 1 fixed dose combination (FDC) tablet under fed conditions: 25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet | None | None | 0 | 24 | 1 | 24 | View |
| High Dose, Fed: 3 Single Tablets | 3 single tablets under fed conditions: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets | None | None | 0 | 24 | 2 | 24 | View |
| Low Dose, Fasted: 2 FDC Tablets | 2 fixed dose combination (FDC) tablets under fasted conditions: 12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets | None | None | 0 | 24 | 4 | 24 | View |
| Low Dose, Fasted: 4 Single Tablets | 4 single tablets under fed conditions: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets | None | None | 0 | 24 | 1 | 24 | View |