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 |
|---|---|---|---|---|---|---|---|---|
| PEERS | Peer mentors who have experience of depression are trained and supervised to deliver depression care. Peers will meet with depressed older adults for 8 weekly meeting lasting approximately 45 -60 minutes. Peer mentors will provide social support defined as emotional, informational and appraisal support that includes coping strategies. Peers will be supervised by a mental health professional. PEERS: Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes. | 1 | None | 1 | 75 | 0 | 75 | View |
| Social Interaction | A study staff member will provide eight weekly social interaction phone calls to the depressed older adult. Social interaction: Study staff will provide a social interaction phone calls to the participants randomized to this condition. | 2 | None | 4 | 74 | 0 | 74 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Admission to Hospice | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |