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 |
|---|---|---|---|---|---|---|---|---|
| Contrast Ultrasound Reccurence Screening | Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT. Optison: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature. | 0 | None | 0 | 53 | 0 | 53 | View |