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: 2025-12-24 @ 4:18 PM
Ignite Modification Date: 2025-12-25 @ 2:15 PM
NCT ID: NCT01687166
Description: Adverse event data is reported for treatment and attempt subjects.
Frequency Threshold: 0
Time Frame: Adverse events were collected from enrollment to end of follow-up ~12Months.
Study: NCT01687166
Study Brief: Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of 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
Blazer Open-Irrigated Ablation Catheter Randomized Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific) 1 None 66 159 104 159 View
FDA Approved Open-Irrigated Ablation Catheter Randomized FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter 1 None 65 167 95 167 View
Blazer Open-Irrigated Ablation Catheter Roll-In Roll-In Cases for Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Blazer Open-Irrigated Ablation Catheter (Boston Scientific) 0 None 19 51 33 51 View
FDA Approved Open-Irrigated Ablation Catheter Roll-In Roll-In Cases for FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. FDA Approved Open-Irrigated Ablation Catheter 0 None 0 1 0 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
AV Fistula SYSTEMATIC_ASSESSMENT Vascular disorders None View
Adverse medication reaction SYSTEMATIC_ASSESSMENT General disorders None View
Alcohol dependency SYSTEMATIC_ASSESSMENT General disorders None View
Arrhythmia (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation (AF) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter (type 1 Isthmus Dependent) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atypical Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atypical atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cancer SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac tamponade/perforation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebrovascular accident (CVA) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain - Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Fluid volume overload( i.e. diuresis, electrolyte imbalance) (Ablation Procedure) SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Head, eyes, ears, nose, throat (HEENT) SYSTEMATIC_ASSESSMENT General disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure symptoms - Unspecified SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematoma (Ablation Procedure) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hiccups SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
IV infiltrate SYSTEMATIC_ASSESSMENT General disorders None View
Multiple heart failure symptoms SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multiple symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other SVT (AVRT, AVNRT, EAT etc. SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Effusion (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Premature atrial contractions (PAC) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Vein Stenosis - Significant (>70%) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary edema - Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary embolism (PE) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rectus sheath hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal insufficiency - Heart failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Sanguineous drainage SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Systemic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
1st degree AV block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
2nd degree AV block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
AV Fistula SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abnormal laboratory values SYSTEMATIC_ASSESSMENT General disorders None View
Adverse medication reaction SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders None View
Allergic reaction (Ablation Procedure) SYSTEMATIC_ASSESSMENT General disorders None View
Anesthesia/Sedation related complication (Ablation Procedure) SYSTEMATIC_ASSESSMENT General disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic root atheromatosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arterial/Venous Thromboembolic Events SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation (AF) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter (type 1 Isthmus Dependent) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Breathing difficulties SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Brugada syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cancer SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain - Ischemic SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cirrhosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cyst on ascending aorta SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Difficulty sleeping SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea on exertion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Edema (Ablation Procedure) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Endocrine SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Exacerbation of existing condition (Ablation Procedure) SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroparesis (Ablation Procedure) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Groin bleed (Ablation Procedure) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Groin pain SYSTEMATIC_ASSESSMENT General disorders None View
Head, eyes, ears, nose, throat (HEENT) SYSTEMATIC_ASSESSMENT General disorders None View
Heart failure symptoms - Unspecified SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematological SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hematoma (Ablation Procedure) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hemorrhage (Ablation Procedure) SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Integumentary SYSTEMATIC_ASSESSMENT General disorders None View
Intracardiac thrombus with no thromboembolic event SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intraventricular conduction delay SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Junctional ectopic rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Long QT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lyme disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Multiple heart failure symptoms SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Non-toxic LLE cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nonsustained ventricular tachycardia (NSVT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain neuromuscular/non cardiovascular (Ablation Procedure) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Effusion (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion - Unrelated to procedure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral edema - Heart failure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Physical trauma SYSTEMATIC_ASSESSMENT General disorders None View
Pleuritis (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Premature atrial contractions (PAC) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Premature ventricular contractions (PVC) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary Vein Stenosis - Mild or Moderate (<70%) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Vein Stenosis - Significant (>70%) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Renal SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Right bundle branch block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Swollen groin SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombus (No embolism) (Ablation Procedure) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Typical atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vagal denervation symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ventricular tachycardia (VT) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Visual Blurring/Disturbances (Ablation Procedure) SYSTEMATIC_ASSESSMENT Eye disorders None View
Atypical Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bradycardia with pauses SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fluid retention SYSTEMATIC_ASSESSMENT General disorders None View
Other SVT (AVRT, AVNRT, EAT etc. SYSTEMATIC_ASSESSMENT Cardiac disorders None View