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 |
|---|---|---|---|---|---|---|---|---|
| Fenofibrate Recipients | Participants who were randomized to the Fenofibrate arm in the FERMIN trial. This drug was administered for 10 days post-randomization. Fenofibrate: 145 mg/d of Tricor (administered as part of the parent FERMIN trial) for 10 days, or renal corrected dose equivalent (depending on renal function) | 0 | None | 0 | 7 | 1 | 7 | View |
| Placebo Recipients | Participants who were randomized to the placebo arm in the FERMIN trial. This drug was administered for 10 days post-randomization. Placebo: Matching placebo (once/day) for 10 days | 0 | None | 0 | 5 | 1 | 5 | View |