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: Survivors | This arm represents the survivors that participated in the intervention. Dyads of cardiac arrest survivors and their caregivers participated in 6 30-minute skills-based sessions. Sessions included provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist delivered all of the sessions. The main intervention goal was to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress. Recovering Together after Cardiac Arrest: The intervention taught resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions took place in person or on Zoom/telephone, depending on the participant's preference and access to technology. | 0 | None | 0 | 7 | 0 | 7 | View |
| Intervention: Caregivers | This arm represents the caregivers that participated in the intervention. Dyads of cardiac arrest survivors and their caregivers participated in 6 30-minute skills-based sessions. Sessions included provision of anticipatory guidance and and resources to manage cardiac arrest-specific stressors. A clinical psychologist delivered all of the sessions. The main intervention goal was to provide dyads with resiliency skills and resources to reduce emotional distress and prevent chronic distress. Recovering Together after Cardiac Arrest: The intervention taught resiliency skills (mindfulness, coping, etc.) to dyads and provider anticipatory guidance and resources to manage stressors specific to cardiac arrest. These sessions took place in person or on Zoom/telephone, depending on the participant's preference and access to technology. | 0 | None | 0 | 7 | 0 | 7 | View |