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 |
|---|---|---|---|---|---|---|---|---|
| Byetta / Bydureon | Exenatide: 4 weeks of exenatide 5 mcg twice daily followed by Bydureon 2mg sc weekly Exenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly) | 0 | None | 0 | 25 | 6 | 25 | View |
| Dapagliflozin | 16 weeks Dapagliflozin, Farxiga, 10mg Dapagliflozin: 10mg | 0 | None | 0 | 25 | 4 | 25 | View |
| Byetta/Bydureon Plus Dapagliflozin | Exenatide: 4 weeks of exenatide followed by 12 weeks of Bydureon 2mg sc once weekly PLUS Dapagliflozin: 16 weeks Dapagliflozin, Farxiga, 10mg Dapagliflozin: 10mg Exenatide: Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly) | 0 | None | 0 | 25 | 7 | 25 | View |
| Placebo | 16 weeks of placebo administration | 0 | None | 0 | 15 | 0 | 15 | View |