Adverse Events Module

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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

Ignite Creation Date: 2025-12-26 @ 11:14 AM
Ignite Modification Date: 2025-12-26 @ 11:14 AM
NCT ID: NCT00116428
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00116428
Study Brief: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NAVISTAR® THERMOCOOL® Catheter Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes. None None 25 139 23 139 View
Antiarrhythmic Drug The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure. None None 0 25 0 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vascular Access Complication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT Investigations None View
Tearing of atrial septum SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemoptysis/Right Kidney Stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Neoplasm/Kidney Nodule SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Emergency Department Visit SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Back pain SYSTEMATIC_ASSESSMENT General disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea, Vomiting/Rigors SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurologic Side Effects SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hematoma/Bleeding/groin pain SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View