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 |
|---|---|---|---|---|---|---|---|---|
| n3-PUFA (Docosahexaenoic Acid (DHA)/EPA) | Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. n3-PUFA: The DHA/EPA softgels contained \~465mg of EPA and \~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\~381 mg) and poloxamer 237, NF (\~8.8 mg). Biopsy: Two muscle biopsies from the upper part of one leg. A small (\~1cm) incision was made through the skin, and a needle was used to remove the muscle. | 0 | None | 0 | 30 | 0 | 30 | View |
| Placebo | Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. Placebo: Looks exactly like the study drug but contained soybean oil with no active ingredient. Biopsy: Two muscle biopsies from the upper part of one leg. A small (\~1cm) incision was made through the skin, and a needle was used to remove the muscle. | 0 | None | 0 | 33 | 0 | 33 | View |