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 Cohort B | Part 2, Cohorts B, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14 | None | None | 0 | 23 | 0 | 23 | View |
| Evacetrapib and Simvastatin | Part 2, Cohorts B, Period 3, Participants will receive evacetrapib 130 mg and simvastatin 40mg orally, once daily on Days 15 - 22. | None | None | 0 | 23 | 0 | 23 | View |
| Atorvastatin | Part 2, Cohorts C, Period 1, Participants will receive atorvastatin orally, once daily on Days 1 - 4. | None | None | 0 | 22 | 0 | 22 | View |
| Evacetrapib Single Cohort C | Part 2, Cohorts C, Period 2, Participants will receive a single oral 130 mg dose of evacetrapib on Days 5-14 | None | None | 0 | 22 | 0 | 22 | View |
| Evacetrapib and Atorvastatin | Part 2, Cohorts C, Period 3, Participants will receive evacetrapib 130 mg orally and atorvastatin 20 mg orally, once daily on Days 15 - 22. | None | None | 0 | 22 | 0 | 22 | View |
| Evacetrapib Single Cohort A | Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib. | None | None | 0 | 16 | 0 | 16 | View |
| Evacetrapib Multiple | Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib 130 mg for 14 days. | None | None | 0 | 16 | 0 | 16 | View |
| Simvastatin | Part 2, Cohorts B, Period 1, Participants will receive simvastatin 40 mg orally, once daily on Days 1 - 4. | None | None | 0 | 24 | 0 | 24 | View |