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 |
|---|---|---|---|---|---|---|---|---|
| ControlRad System | Participant will undergo Cardiac catheterization or electrophysiology implant procedures with the ControlRad system installed in Cath lab room 5 ControlRad System: Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5. | 0 | None | 0 | 85 | 0 | 85 | View |
| Without ControlRad System | Participant will undergo the cardiac catheterization or electrophysiology implant procedures per standard of care. Meaning, without the ControlRad system installed in Cath lab room 5. Without ControlRad System: Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device. | 0 | None | 1 | 85 | 0 | 85 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac Perforation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |