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 @ 12:20 AM
Ignite Modification Date: 2025-12-25 @ 10:24 PM
NCT ID: NCT00813358
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT00813358
Study Brief: Zenith TX2® Post-market Approval Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Endovascular Repair treatment Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device 32 None 83 115 14 115 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
DEAFNESS UNILATERAL SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders None View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ENTEROCOLONIC FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
HEPATIC FAILURE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
ABDOMINAL WALL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations None View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
BACTEREMIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
CELLULITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URETEROLITHIASIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
PERIPHERAL EMBOLISM SYSTEMATIC_ASSESSMENT Vascular disorders None View
PERIPHERAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Vascular disorders None View
SUBCLAVIAN ARTERY OCCLUSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders None View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
CYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
FEBRILE NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ACUTE CORONARY SYNDROME SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CORONARY ARTERY DISEASE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PULSELESS ELECTRICAL ACTIVITY SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CENTRAL NERVOUS SYSTEM EPIDERMOID TU SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
HYDROCELE SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
ENTEROCUTANEOUS FISTULA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FEMORAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTROESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GASTROINTESTINAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ILEUS PARALYTIC SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INGUINAL HERNIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
SMALL INTESTINAL OBSTRUCTION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
SPLENIC ARTERY ANEURYSM SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders None View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders None View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
DEATH SYSTEMATIC_ASSESSMENT General disorders None View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders None View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders None View
PHYSICAL DECONDITIONING SYSTEMATIC_ASSESSMENT General disorders None View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders None View
STENT-GRAFT ENDOLEAK SYSTEMATIC_ASSESSMENT General disorders None View
BILE DUCT STONE SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
CLOSTRIDIUM DIFFICILE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
DEVICE RELATED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
EPIDIDYMITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
GASTROINTESTINAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
MENINGITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
OSTEOMYELITIS 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
STAPHYLOCOCCAL ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations None View
STAPHYLOCOCCAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
URINARY TRACT INFECTION ENTEROCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations None View
ANKLE FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ARTERIAL BYPASS STENOSIS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
INCOMPLETE SPINAL FUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
JOINT DISLOCATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
OVERDOSE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
PELVIC FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
RADIUS FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
ROAD TRAFFIC ACCIDENT SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
VASCULAR PSEUDOANEURYSM SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
BLOOD CREATININE INCREASE SYSTEMATIC_ASSESSMENT Investigations None View
ENDOBRONCHIAL ULTRASOUND SYSTEMATIC_ASSESSMENT Investigations None View
LABORATORY TEST ABNORMAL SYSTEMATIC_ASSESSMENT Investigations None View
TROPONIN INCREASED SYSTEMATIC_ASSESSMENT Investigations None View
DIABETIC KETOACIDOSIS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
GOUT SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPERGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
HYPOGLYCEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
TYPE 2 DIABETES MELLITUS SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
INTERVERTEBRAL DISC PROTRUSION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCULAR WEAKNESS 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
SACROILIAC JOINT DYSFUNCTION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BREAST CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
CHRONIC MYELOID LEUKEMIA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
PANCOAST'S TUMOUR SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
BRAIN INJURY SYSTEMATIC_ASSESSMENT Nervous system disorders None View
CAROTID ARTERY OCCLUSION SYSTEMATIC_ASSESSMENT Nervous system disorders None View
CEREBROVASCULAR ACCIDENT SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PARAPARESIS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PARAPLEGIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SEIZURE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SEIZURES SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SPINAL CORD ISCHAEMIA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
TRANSIENT ISCHAEMIC ATTACK SYSTEMATIC_ASSESSMENT Nervous system disorders None View
DEVICE KINK SYSTEMATIC_ASSESSMENT Product Issues None View
MEDICAL DEVICE ENTRAPMENT SYSTEMATIC_ASSESSMENT Product Issues None View
BIPOLAR DISORDER SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
CHRONIC KIDNEY DISEASE 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
CYSTOCELE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
ACUTE RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
AORTO-BRONCHIAL FISTULA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ASPIRATION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ATELECTASIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BRONCHIAL SECRETION RETENTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CHRONIC OBSTRUCTIVE PULMONARY DISEAS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HAEMOPTYSIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HYPOXIA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PNEUMOTHORAX SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PRODUCTIVE COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY EMBOLISM SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY HAEMORRHAGE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY MASS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CRANIOTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
INCARCERATED HERNIA REPAIR SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
INTESTINAL RESECTION SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
MECHANICAL VENTILATION SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
OXYGEN THERAPY SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
PANCREATECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
PERIPHERAL ENDARTERECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
PULMONARY RESECTION SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
VASCULAR GRAFT SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
ANEURYSM RUPTURED SYSTEMATIC_ASSESSMENT Vascular disorders None View
AORTIC ANEURYSM SYSTEMATIC_ASSESSMENT Vascular disorders None View
AORTIC DISSECTION SYSTEMATIC_ASSESSMENT Vascular disorders None View
AORTIC INTRAMURAL HAEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
ARTERIAL THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders None View
DEEP VEIN THROMBOSIS SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
INTERMITTENT CLAUDICATION SYSTEMATIC_ASSESSMENT Vascular disorders None View
PERIPHERAL ARTERY ANEURYSM SYSTEMATIC_ASSESSMENT Vascular disorders None View
PERIPHERAL ARTERY ANEURYSM RUPTURE SYSTEMATIC_ASSESSMENT Vascular disorders None View
PERIPHERAL ARTERY OCCLUSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
CELLULITIS STAPHYLOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations None View
ESCHERICHIA INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
CONCUSSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
SPINAL COMPRESSION FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
STERNAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
THORACIC VERTEBRAL FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
HYPERNATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
KNEE DEFORMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
KETONURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
STRESS URINARY INCONTINENCE SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URINARY TRACT OBSTRUCTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RECTOCELE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
DYSPNOEA EXERTIONAL SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
RESPIRATORY ARREST SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SPLENECTOMY SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
ANEURYSM SYSTEMATIC_ASSESSMENT Vascular disorders None View
VAGINAL PROLAPSE SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ARRHYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View