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 |
|---|---|---|---|---|---|---|---|---|
| Patients | 221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up Intramedullary nailing for fracture fixation | 1 | None | 26 | 221 | 0 | 221 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Surgical site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |