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 |
|---|---|---|---|---|---|---|---|---|
| All Subjects Receiving CSA Cryospray | All subjects enrolled will received CSA cryospray. CryoSpray Ablation (tm): The CryoSpray Ablation(TM) System is a cryosurgical device utilizing a low-pressure liquid nitrogen spray tip CSATM Catheter. Medical grade liquid nitrogen is the cryogen used in the device. The device is used to destroy unwanted tissue by the application of extreme cold with the focused application to select tissue. The cryogen is stored in a liquid nitrogen holding tank integrated into the system. | None | None | 0 | 5 | 0 | 5 | View |