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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT02006069
Description: None
Frequency Threshold: 0
Time Frame: 6 months to 12 months after randomization
Study: NCT02006069
Study Brief: MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BIVP MPP OFF: Continuous BiVP after 6 months. Patients from both Phases were analyzed together using as-treated analysis. 18 None 190 555 118 555 View
MPP ON MPP ON: feature is enabled after 6 months MPP: All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device. The MPP feature was evaluated in two study phases. Patients randomized to MPP in Phase I had MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II had MPP programmed per protocol requirements ("mandated MPP programming"). Patients from both Phases were analyzed together using as-treated analysis. 4 None 82 271 67 271 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anticoagulant Overdose SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hemopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute Myocarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic Valve Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial or Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiorespiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Exacerbation of Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral Valve Dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pacemaker Mediated Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sudden Cardiac Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Valve Damage SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Exacerbation of Heart Failure SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperthyroidism Caused by Amiodarone SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Cataract SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal Affliction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bleeding/Hematoma/Seroma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Downhill Varicose and Diverticulum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Esophageal Varices SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inguinal Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Obstipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatic Cystic Lesion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Umbilical Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drug Side Effect SYSTEMATIC_ASSESSMENT General disorders None View
Infection SYSTEMATIC_ASSESSMENT General disorders None View
Nausea, Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain at Pulse Generator Site SYSTEMATIC_ASSESSMENT General disorders None View
Gallbladder Disease SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Liver Injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Drug Allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Interstitial Pulmonary Fibrosis SYSTEMATIC_ASSESSMENT Immune system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bleeding/Hematoma/Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bone Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac Perforation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Coronary Sinus Dissection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Erosion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mild Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain at Pulse Generator Site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pneumothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pocket Swelling SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic Subdural Hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diabetes SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Electrolyte Disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fluid Accumulation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Obesity SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gout SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myogelosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Benign Tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ureteral Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebellar Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abnormal Lead Pacing Impedance <= 200 OHMS or >=2000 OHMS SYSTEMATIC_ASSESSMENT Product Issues None View
Elevated Pacing Thresholds/Loss of Capture SYSTEMATIC_ASSESSMENT Product Issues None View
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall) SYSTEMATIC_ASSESSMENT Product Issues None View
Infection SYSTEMATIC_ASSESSMENT Product Issues None View
Lead Dislodgement or Migration SYSTEMATIC_ASSESSMENT Product Issues None View
Lead Fracture SYSTEMATIC_ASSESSMENT Product Issues None View
Oversensing SYSTEMATIC_ASSESSMENT Product Issues None View
Pulse Generator Migration SYSTEMATIC_ASSESSMENT Product Issues None View
Therapy for Non-Ventricular Rhythm SYSTEMATIC_ASSESSMENT Product Issues None View
Undersensing SYSTEMATIC_ASSESSMENT Product Issues None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dementia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep Apnea SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Influenza SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Larynx Perforation After Tee SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pseudo-Nodular Lung Consolidation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Limb Gangrene SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bone Fracture SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nose Resection SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding/Hematoma/Seroma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bypass Graft Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intracardiac Thrombus SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lower Extremity Claudication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral Artery Disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
TIA SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Malignant Tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Atrial or Ventricular Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Exacerbation of Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart Transplant SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pacemaker Mediated Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperthyreosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Mild Diverticulosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain at Pulse Generator Site SYSTEMATIC_ASSESSMENT General disorders None View
Worsening of General Patient's Condition SYSTEMATIC_ASSESSMENT General disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bone Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Coronary Sinus Dissection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bodily Rejection Phenomena SYSTEMATIC_ASSESSMENT Product Issues None View
Elevated Pacing Thresholds/Loss of Capture SYSTEMATIC_ASSESSMENT Product Issues None View
Extracardiac Stimulation (Phrenic Nerve, Diaphragm, Chest Wall) SYSTEMATIC_ASSESSMENT Product Issues None View
Lead Dislodgement or Migration SYSTEMATIC_ASSESSMENT Product Issues None View
Oversensing SYSTEMATIC_ASSESSMENT Product Issues None View
Pacemaker Mediated Tachycardia SYSTEMATIC_ASSESSMENT Product Issues None View
Palpitation SYSTEMATIC_ASSESSMENT Product Issues None View
Therapy for Non-Ventricular Rhythm SYSTEMATIC_ASSESSMENT Product Issues None View
Sleep Apnea SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Kidney Disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elective Replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding/Hematoma/Seroma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous Occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View