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 |
|---|---|---|---|---|---|---|---|---|
| Lower Extremity Amputees | Community walking trial comparing usual prosthetic foot with investigational prosthetic foot. Investigational prosthetic foot: Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot. | 0 | None | 0 | 31 | 6 | 31 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| falls - investigational foot condition B | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| falls - usual foot condition A2 | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Residual limb pain usual foot condition A2 | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Residual limb pain investigational foot condition B | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |