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 |
|---|---|---|---|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time Health Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research | 0 | None | 0 | 15 | 0 | 15 | View |
| Health Information | Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites | 0 | None | 0 | 15 | 0 | 15 | View |