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 |
|---|---|---|---|---|---|---|---|---|
| Vitamin D Sufficient | Subjects with baseline 25-OH vitamin D levels ≥ 32 ng/ml were not treated with ergocalciferol. | None | None | 0 | 0 | 0 | 0 | View |
| Vitamin D Insufficient | Subjects found to have an initial 25-OH vitamin D level \< 32 ng/mL were treated with ergocalciferol 50,000 IU every other day x 5 doses (250,000 IU total) and returned for repeat laboratory studies. | None | None | 0 | 36 | 0 | 36 | View |