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 |
|---|---|---|---|---|---|---|---|---|
| Cross-over Randomization 1: Fiber Plus Fish Oil Followed by Comparator | Period 1: participants receive fiber supplement and fish oil supplements PO daily on days 1-30. Washout: at least 60 days. Period 2: participants receive the comparators supplements also PO daily on days 90-120. | 0 | None | 0 | 19 | 0 | 19 | View |
| Cross-over Randomization 2: Comparator Followed by Fiber Plus Fish Oil | Period 1: participants receive the comparators supplements PO daily on days 1-30. Washout: at least 60 days. Period 2: participants receive fiber supplement and fish oil supplements also PO daily on days 90-120. | 0 | None | 0 | 16 | 0 | 16 | View |