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 |
|---|---|---|---|---|---|---|---|---|
| Kenya Intervention Baseline | Baseline cohort at Kenya intervention site | 29 | None | 0 | 2856 | 0 | 2856 | View |
| Kenya Intervention Implementation | Implementation cohort at Kenya intervention site | 10 | None | 0 | 3428 | 0 | 3428 | View |
| Kenya Control Baseline | Baseline cohort at Kenya control site | 11 | None | 0 | 2520 | 0 | 2520 | View |
| Kenya Control Implementation | Implementation cohort at Kenya control site | 10 | None | 0 | 3177 | 0 | 3177 | View |
| Uganda Intervention Baseline | Baseline cohort at Uganda intervention site | 11 | None | 0 | 1408 | 0 | 1408 | View |
| Uganda Intervention Implementation | Implementation cohort at Uganda intervention site | 4 | None | 0 | 1903 | 0 | 1903 | View |
| Uganda Control Implementation | Implementation cohort at Uganda control site | 2 | None | 0 | 2855 | 0 | 2855 | View |