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 |
|---|---|---|---|---|---|---|---|---|
| Healthy Control Non-Dosimetry Group | The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer | 0 | None | 0 | 2 | 0 | 2 | View |
| Patient Group | The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40 PSMA-based 18F-DCFPyL PET tracer: PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer | 0 | None | 0 | 12 | 0 | 12 | View |