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 |
|---|---|---|---|---|---|---|---|---|
| Diagnostic (Helical CT, PET/CT, MRI, CBCT) | Patients undergo helical (Computed Tomography) CT,(Positron Emission Tomography and Computed Tomography) PET/CT, (Magnetic Resonance Imaging) MRI, and (Cone-Beam Computed Tomography) CBCT scans. Patients also undergo therapeutic conventional surgical resection of tumor. Computed Tomography: Undergo helical CT scan Positron Emission Tomography and Computed Tomography Scan: Undergo PET/CT scan Cone-Beam Computed Tomography: Undergo CBCT scan Magnetic Resonance Imaging: Undergo MRI scan Therapeutic Conventional Surgery: Undergo resection of tumor Histopathologic Examination: Correlative studies | 0 | None | 0 | 8 | 0 | 8 | View |