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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT03618095
Description: None
Frequency Threshold: 5
Time Frame: Events collected through the Termination of the study, majority of patient an average of 30 days.
Study: NCT03618095
Study Brief: REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Roll-In Cohort Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System for sites that do not have implantation experience with the LOTUS Edge Valve System. At least 2 per site needed. LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System 8 None 42 63 34 63 View
Bicuspid Cohort Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System in a native bicuspid aortic valve. LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System 2 None 24 45 35 45 View
Main Cohort Transcatheter Aortic Valve Replacement (TAVR) with the LOTUS Edge Valve System LOTUS Edge Valve System: TAVR with the LOTUS Edge Valve System 14 None 175 274 176 274 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chordae tendinae rupture SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chronic left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Paravalvular aortic regurgitation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Prosthetic cardiac valve thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blindness SYSTEMATIC_ASSESSMENT Eye disorders None View
Open angle glaucoma SYSTEMATIC_ASSESSMENT Eye disorders None View
Papilloedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal infarction SYSTEMATIC_ASSESSMENT Eye disorders None View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intra-abdominal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peritoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retroperitoneal haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cardiac complication associated with device SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Device embolisation SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders None View
Jaundice SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Endocarditis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Implant site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Structural valve deterioration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular procedure complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations None View
Echocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations None View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations None View
Troponin increased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chondrocalcinosis pyrophosphate SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint effusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scoliosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Malignant neoplasm of renal pelvis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Alcoholic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cubital tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Embolic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Facial paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischaemic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mononeuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Device failure SYSTEMATIC_ASSESSMENT Product Issues None View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bladder neck obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bladder outlet obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ovarian mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Mediastinal haematoma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arterial haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral artery thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders None View
Shock haemorrhagic SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaemia macrocytic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Haemorrhagic disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukaemoid reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Accelerated idioventricular rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrioventricular block first degree SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View