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 |
|---|---|---|---|---|---|---|---|---|
| Alianza Latina | The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators. This number includes 100 caregivers of 84 care recipients who underwent the Alianza Latina care support intervention; 26 caregivers were part of 10 clusters of 2 (n=5), 3 (n=4), and 4 (n=1) caregivers of the same person with dementia. This number also includes results from 59 primary care providers who underwent a dementia training delivered as standard training by the KU Alzheimer's Disease Research Center. Data for all 3 groups are provided together because they are part of the same intervention, and not interventions that were compared. Mortality only happened among care recipients. | 6 | None | 0 | 0 | 0 | 0 | View |