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 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:26 PM
NCT ID: NCT03650556
Description: An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
Frequency Threshold: 0
Time Frame: 15 months
Study: NCT03650556
Study Brief: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent 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
Enrolled A patient is considered enrolled from the moment the patient provides written informed consent and meets all eligibility criteria 2 None 59 224 29 224 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bleeding/Anemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cerebrovascular Accident/Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Coronary Artery Thrombosis/Occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Elective Procedure/Surgery NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heart Failure/Pump Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Renal Decompensation/Acute Kidney Injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Compromise/Decompensation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope/Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Valve Insufficiency NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Volume Overload NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute Ischemic Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bowel Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Collapse NON_SYSTEMATIC_ASSESSMENT General disorders None View
Colon Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fracture of Humerous NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower GI Bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pelvic Inflammatory Disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Penile Fracture NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Rectal and Vaginal Prolapse Repair NON_SYSTEMATIC_ASSESSMENT General disorders None View
Right Hip Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sick Sinus Symptom NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sudden Cardiac Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Allergic Reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Chest Pain/Discomfort NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Perforation or Tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastroparesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pericardial Effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Jaw and Neck Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Tracheobronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Trauma NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Air Embolism NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain/Discomfort NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pericardial Effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural Effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Thrombosis/Thrombus NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Transient Ischemic Attack NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vascular Access Complication NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular Bleeding/Local Hematoma/Ecchymosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Volume Overload NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Congestive Heart Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated Troponin NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Esophageal Inflammation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fluid Retention NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hepatohepatomegaly With Elevated Liver Enzymes NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Jaw Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Shoulder Blade/ Arm Pit Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Trochanteric Bursitis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Urinary Retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View