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 |
|---|---|---|---|---|---|---|---|---|
| Family-based CBT | Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician. | None | None | 0 | 70 | 0 | 70 | View |
| Information Monitoring | Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Information Monitoring: Packet providing information on strategies for coping with anxiety | None | None | 0 | 66 | 0 | 66 | View |