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 |
|---|---|---|---|---|---|---|---|---|
| Tricor (145 mg/Day) | Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks. Fenofibrate tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks | None | None | 0 | 24 | 4 | 24 | View |
| Placebo | Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks. Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks | None | None | 0 | 23 | 3 | 23 | View |
| Lovaza (900 mg/Day) | Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks. Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks. | None | None | 0 | 28 | 8 | 28 | View |
| Lovaza (3,600 mg/Day) | Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks. Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks. | None | None | 0 | 25 | 8 | 25 | View |