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 |
|---|---|---|---|---|---|---|---|---|
| Active VITATOPS Tablet (Folic Acid 2mg, B6 25mg , B12 500ug) | Active Treatment Arm: VITATOPS study tablet (folate 2 mg, B6 25 mg, B12 500 ug). Taken daily for the duration of the study. Active VITATOPS Tablet (folic acid 2mg, B6 25mg , B12 500ug): multivitamin | None | None | 0 | 4089 | 0 | 4089 | View |
| Placebo Tablet | Placebo Treatment Arm: The placebo tablet will have the same appearance, taste and texture as the vitamin preparation and contains excipients, coating and coating aids. | None | None | 0 | 4075 | 0 | 4075 | View |