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 |
|---|---|---|---|---|---|---|---|---|
| Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D | Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements. | None | None | 0 | 11 | 0 | 11 | View |
| Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D | Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements). | None | None | 0 | 11 | 0 | 11 | View |