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: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT03504020
Description: None
Frequency Threshold: 5
Time Frame: Enrollment- 9 months
Study: NCT03504020
Study Brief: ECG Belt for CRT Response
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ECG Belt The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits. ECG Belt Research System: The ECG Belt Research System is used to identify the best vector and programming parameters. 12 None 68 200 0 200 View
Control Arm Standard CRT through 9 months follow-up. 6 None 52 208 0 208 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Blood Loss Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Nephrogenic Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 25 View
Accelerated Idioventricular Rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Acute Left Ventricular Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Arrhythmic Storm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Atrial Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac Failure Acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac Failure Chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiac Ventricular Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Chronic Left Ventricular Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Ischaemic Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Mitral Valve Incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Myocardial Ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Pulseless Electrical Activity SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Supraventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 25 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 25 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Retinal Detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 25 View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Pancreatitis Acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Multiple Organ Dysfunction Syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Unevaluable Event SYSTEMATIC_ASSESSMENT General disorders MedDRA 25 View
Transplant Rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 25 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Endocarditis Enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Enterococcal Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Escherichia Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Implant Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Pneumonia Escherichia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25 View
Head Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Ligament Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Lumbar Vertebral Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Tibia Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 25 View
Liver Function Test Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 25 View
Calciphylaxis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Failure To Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hyperglycaemic Hyperosmolar Nonketotic Syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Chest Wall Haematoma SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Intervertebral Disc Degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Neuropathic Arthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25 View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Metastases To Peritoneum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Cauda Equina Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Metabolic Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25 View
Device Lead Damage SYSTEMATIC_ASSESSMENT Product Issues MedDRA 25 View
Lead Dislodgement SYSTEMATIC_ASSESSMENT Product Issues MedDRA 25 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
End Stage Renal Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Renal Impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Acute Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Bronchiectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25 View
Aortic Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Intermittent Claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Peripheral Arterial Occlusive Disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Peripheral Vascular Disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Shock Haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 25 View
Metastases To Central Nervous System SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 25 View
Chronic Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 25 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25 View
Other Events(If Any):