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 |
|---|---|---|---|---|---|---|---|---|
| Patient Buddy Subject Only/Not Dyad | Only the patients (subjects) were enrolled in this part of the study, not dyads. The numbers only represent the patient enrollment numbers. Patients were given phones loaded with the Buddy App, which was used to enter medications, issues, and orientation questions. They were seen on days 15 and 30 and received phone calls on days 7 and 21 inquiring about issues that would need medical attention. | 0 | None | 0 | 116 | 0 | 116 | View |
| Standard of Care Subject Only/Not Dyad | Subjects randomized to standard of care and not the Buddy App. Just the patients counted and reported, not the dyads. | 0 | None | 0 | 116 | 0 | 116 | View |