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 |
|---|---|---|---|---|---|---|---|---|
| NUVISION NAV Ultrasound Catheter | Participants with atrial arrhythmia and ventricular arrhythmia were enrolled and treated per investigator's standard of care while using the NUVISION NAV ultrasound catheter for ultrasound imaging and were followed-up until 7 days post-procedure. Atrial arrhythmia included subgroups as (a) scar-related atrial tachycardia (AT, including atypical atrial flutter)/ redo procedures resulting from previous atrial fibrillation ablation, (b) persistent atrial fibrillation (PsAF), and (c) paroxysmal atrial fibrillation (PVF). Ventricular arrhythmia included subgroups as (a) ventricular tachycardia (VT) including ischemic and non-ischemic VT and cardiomyopathy and idiopathic VT, and (b) premature ventricular complex (PVC). | 0 | None | 2 | 30 | 2 | 30 | View |