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 2 - Niacinamide Arm | Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months Niacinamide: 100mg tablets twice daily | 0 | None | 0 | 2 | 0 | 2 | View |
| Group 3 - Placebo Wait-listed Arm | Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months Placebo: Placebo tablet twice daily | 0 | None | 0 | 3 | 0 | 3 | View |
| Group 1 - Niacin Arm | Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months Niacin: 100mg tablets twice daily | 0 | None | 0 | 2 | 0 | 2 | View |