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 |
|---|---|---|---|---|---|---|---|---|
| Partners4Pain Program | Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks | 0 | None | 0 | 26 | 8 | 26 | View |
| Key to Wellbeing Program | Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks | 0 | None | 2 | 25 | 14 | 25 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Feeling more upset than usual when reminded of the past | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Increased feelings of sadness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Increased feelings of anxiousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Feeling more tired or fatigued than usual | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Feeling more isolated or lonely | SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Worsening back or neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Increased muscle soreness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |