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 |
|---|---|---|---|---|---|---|---|---|
| Transrectal | Patients will receive a transrectal MRI-guided prostate biopsy. Transrectal MRI-guided prostate biopsy: Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer. Antibiotic (prophylaxis): For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA). No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy. | 0 | None | 0 | 280 | 8 | 280 | View |
| Transperineal | Patients will receive a transperineal MRI-guided prostate biopsy. Transperineal MRI-guided prostate biopsy: Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking. | 0 | None | 0 | 287 | 1 | 287 | View |