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 |
|---|---|---|---|---|---|---|---|---|
| Outreach-ER (Caregivers of PLWD) | Caregivers of PLWD also participating in the Outreach-ER program. | 0 | None | 0 | 4 | 0 | 4 | View |
| Outreach-ER (People Living With Dementia) | Outreach-ER is a psychosocial intervention designed by dementia experts in the field of care partner interventions. The care plan will be personalized to the needs of the care partner/PLWD. Outreach-ER: The intervention is similar to other care intervention/support programs such as REACH or New York University Caregiver Intervention (NYCUI). The Intervention is designed to be delivered over phone/virtual and in-home and will be conducted by Amplio, LLC consultants. | 0 | None | 0 | 4 | 0 | 4 | View |