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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Standard Tai Ji Quan | Serving as an active comparison arm, participants in this intervention will exercise a series of Tai Ji Quan-based movements that are specifically designed for older adults to improve strength/balance, cognitive function, and mobility. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition | 0 | None | 2 | 107 | 10 | 107 | View |
| Cognitively Enhanced Tai Ji Quan | Participants in this arm will exercise a series of Tai Ji Quan-based movements with configurations that are specifically designed for older adults to improve cognitive function, dual-task ability, strength/balance, and mobility. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition | 0 | None | 3 | 105 | 10 | 105 | View |
| Stretching | Serving as a control arm, participants in this intervention will engage in a series of light exercise activities consisting of breathing, stretching, and body relaxation. The Go for Exercise \& Healthy Aging Project: Exercise and Cognition | 0 | None | 2 | 106 | 11 | 106 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Serious event | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Other events | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |