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 |
|---|---|---|---|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth. Cognitive Behavioral Therapy for loneliness (CBT-L): 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use. | 0 | None | 0 | 63 | 1 | 63 | View |
| Health Education | Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth. Physical Health Education Training (PHET): Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle. | 0 | None | 0 | 62 | 1 | 62 | View |