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 |
|---|---|---|---|---|---|---|---|---|
| Telephone Discussion Groups | Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury). | 0 | None | 0 | 76 | 0 | 76 | View |
| Education Sessions | Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook. | 0 | None | 0 | 76 | 0 | 76 | View |
| Usual Care | Participants do not receive any services. | 0 | None | 0 | 75 | 0 | 75 | View |