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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 | Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days Neomycin: 500 mg po bid for 14 days Placebo: placebo for 14 days tid | None | None | 0 | 16 | 1 | 16 | View |
| Group 2 | Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days Neomycin: 500 mg po bid for 14 days Rifaximin: 550 mg po tid | None | None | 0 | 15 | 1 | 15 | View |