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 |
|---|---|---|---|---|---|---|---|---|
| DAPA/MET XR | Dapagliflozin plus metformin XR- 5 mg/1000 mg with meal for 4 weeks DAPA/MET XR- 5mg/1000 mg BID final dose for 20 weeks DAPA/MET XR: final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks | 0 | None | 0 | 20 | 6 | 20 | View |
| Dapaglifloxin | Dapagliflozin- 10 mg once daily before first meal for 24 weeks DAPA: 10 mg dapagliflozin QD for 20-24 weeks | 0 | None | 0 | 21 | 6 | 21 | View |
| Metformin XR | Metformin XR with 500 mg once a day for 2 weeks, followed by 500 mg twice a day for 2 weeks, followed by 500 mg in the AM, 1000 mg in the PM for 2 weeks, with 1000 mg twice a day as the final dose for 20 weeks MET XR: 1000 mg Metformin XR BID for 20-24 weeks | 0 | None | 0 | 25 | 5 | 25 | View |