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 @ 4:20 PM
Ignite Modification Date: 2025-12-25 @ 2:16 PM
NCT ID: NCT01246466
Description: None
Frequency Threshold: 1
Time Frame: Treatment to 24 months
Study: NCT01246466
Study Brief: Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AtriCure Bipolar System Combined With a Catheter Ablation Procedure using the AtriCure Bipolar System plus a catheter ablation Hybrid ablation procedure: AtriCure Bipolar System plus a catheter ablation None None 16 24 20 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Embolic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cardiac Perforation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Embolic Stroke - Epicardial Ablation Procedure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vocal Cord Paresis SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Mediastinal Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Atrial Fibrillation - Other Relationship SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial Flutter - Other Relationship SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular Fibrillation - Other Relationship SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Visual Impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Implantable Defribrillator Malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Intervertebral Disc Degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Prostate Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Alcohol Withdrawal Syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Embolic Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac Perforation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cardiac Vein Perforation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Embolic Stroke - Epicardial Ablation Procedure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vocal Cord Paresis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Mouth Ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Postoperative Ileus SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Neuropathy Peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Mediastinal Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Anaemia - Other Relationship SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial Flutter - Other Relationship SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular Block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA View
Visual Impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal Distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest Pains SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Implantable Defribillator Malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Ulnar Nerve Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Intervertebral Disc Degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Prostate Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Essential Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Alcohol Withdrawal Syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Respiratory Distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View