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 |
|---|---|---|---|---|---|---|---|---|
| Evacetrapib | Single oral dose of Evacetrapib administered alone on Day 1 of Period 1. Evacetrapib: Administered orally | None | None | 0 | 34 | 5 | 34 | View |
| Evacetrapib + Omeprazole | In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20. Evacetrapib will be coadministered once, orally on Day 14. Evacetrapib: Administered orally Omeprazole: Administered orally | None | None | 0 | 33 | 2 | 33 | View |
| Evacetrapib + Omeprazole Follow-up | Evacetrapib + Omeprazole Follow-up will occur at least 14 days after last dose of Evacetrapib on Day 14. | None | None | 0 | 33 | 3 | 33 | View |