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 |
|---|---|---|---|---|---|---|---|---|
| Exercise + Health Education + Bingo | Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises AND health information on fall risks + diet/nutrition. Socially-Based Exercise Intervention for Older Adults: A socially-based app that incorporates exercise and health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors | 1 | None | 3 | 73 | 0 | 73 | View |
| Exercise + Bingo | Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating exercises ONLY. Socially-Based Exercise Intervention for Older Adults: A socially-based app that incorporates exercise into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors | 0 | None | 6 | 53 | 0 | 53 | View |
| Health Education + Bingo | Socially-Based Exercise Intervention for Older Adults. Participants use the Bingocize app incorporating health information on fall risks + diet/nutrition ONLY. Socially-Based Exercise Intervention for Older Adults: A socially-based app that incorporates health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors | 0 | None | 3 | 50 | 0 | 50 | View |
| Bingo Only | Participants use the Bingocize app to play bingo only. | 0 | None | 1 | 43 | 0 | 43 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cancer Diagnosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Aneuryism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Wrist Fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Unspecified Health Issues | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| stroke | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |