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 |
|---|---|---|---|---|---|---|---|---|
| Ceramic On Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the Biolox delta 38 mm ceramic femoral head. | 16 | None | 35 | 110 | 0 | 110 | View |
| Metal on Metal | Patients that underwent total hip arthroplasty, who received a M2a-38mm cup and the 38 mm cobalt chromium molybdenum (CoCrMo) modular femoral head. | 13 | None | 38 | 101 | 0 | 101 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cancer | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cardiovascular problems | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Muculoskeletal problems | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Revision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |