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 |
|---|---|---|---|---|---|---|---|---|
| Ekso Treatment | Ekso gait training 3x/week for 8 weeks. While outcome measures were assessed in two groups, Recently Injured and Chronically Injured, adverse events were measured in one group out of all total participants because all participants underwent the same intervention (ie this one a 1-arm study) | 0 | None | 0 | 60 | 22 | 60 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ankle swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| dizziness or sycope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Neurological symptoms | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Skin issues | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Concurrent medical issues | SYSTEMATIC_ASSESSMENT | General disorders | None | View |