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 |
|---|---|---|---|---|---|---|---|---|
| Screened Veteran | This is the first, VA-engaged Veteran partner of each couple that is referred to the study and has at least one positive VA mental health screen for depression, heavy drinking, PTSD, or relationship dissatisfaction. In the manuscript (Crasta et al., 2023), we refer to these participants as "VA-engaged Veterans," "Identified Patients," or "Patients" for short. | 0 | None | 0 | 20 | 1 | 20 | View |
| Second Partner | This is a romantic partner identified by the Screened Veteran to participate in the study with them and work on their relationship. This partner may or may not be a Veteran themselves. In the manuscript (Crasta et al., 2023), we also refer to these participants as "Supporting Partners" or simply "Partners" for short. | 0 | None | 0 | 20 | 1 | 20 | View |