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 |
|---|---|---|---|---|---|---|---|---|
| Intervention Group | Multidomain intervention included: (1) physical activity; (2) cognitive intervention; and (3) social intervention as well as (4) management of metabolic and vascular risk factors. Physical activity and cognitive stimulation interventions will be performed at separate sessions | 0 | None | 0 | 30 | 0 | 30 | View |
| Control Group | The control group will receive general health advice every 3 months based on their physical examination and blood results. They will be provided information on the vascular risk factors for dementia and will receive instruction and handouts on diet and exercise. | 0 | None | 0 | 30 | 0 | 30 | View |