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 @ 11:11 PM
Ignite Modification Date: 2025-12-26 @ 11:11 PM
NCT ID: NCT03775512
Description: The safety analysis set included all enrolled participants who had the investigational device inserted, regardless if RF energy was delivered.
Frequency Threshold: 0
Time Frame: Up to 20 months
Study: NCT03775512
Study Brief: Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With 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
Main Arm: QDOT Micro Catheter Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and radiofrequency (RF) ablation using QDOT Micro Catheter for pulmonary vein isolation with nMARQ radiofrequency (RF) generator. 1 None 32 177 58 177 View
Variable Flow Arm: QDOT Micro Catheter Participants with symptomatic PAF who have failed at least one antiarrhythmic drug were ablated with electrophysiology mapping and RF ablation using QDOT Micro Catheter for variable flow with nMARQ RF generator. 1 None 14 87 19 87 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac tamponade NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Arteriovenous fistula NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinus node dysfunction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac valve fibroelastoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cyst NON_SYSTEMATIC_ASSESSMENT General disorders None View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aortic dilatation NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiatus hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Aortic valve calcification NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular disorder NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Retroperitoneal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders None View
Corona virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haemorrhagic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral vascular disorder NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac Tamponade/Perforation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Phrenic Nerve Injury / Diaphragmatic Paralysis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Major Vascular Access Complication / Bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary Edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Non-Cardiac Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Incision site hemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary tract injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laboratory test abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Groin pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fluid overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vaginal hemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pulmonary vein stenosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heart rate increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Anaesthetic complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View