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 @ 4:17 AM
Ignite Modification Date: 2025-12-26 @ 3:17 AM
NCT ID: NCT01568320
Description: None
Frequency Threshold: 5
Time Frame: 5-Year
Study: NCT01568320
Study Brief: Zenith® Dissection Clinical Trial
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 Endovascular Treatment (Zenith) Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta. 20 None 63 73 40 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral valve prolapse SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Epigastric discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erosive oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastoroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Large intestine ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophageal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophageal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting 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
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Nodule SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Stent-graft endoleak SYSTEMATIC_ASSESSMENT General disorders None View
Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacillus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular access site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Device use error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incisional hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Postoperative respiratory failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skull fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count increased SYSTEMATIC_ASSESSMENT Investigations None View
Adult failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthraglia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral disc degeneration SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spondylolisthesis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic carcinoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Sarcoma metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Motor dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nervous system disorder 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
Subarachnoid haemorrhage 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 lead damage SYSTEMATIC_ASSESSMENT Product Issues None View
Stent malfunction SYSTEMATIC_ASSESSMENT Product Issues None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium 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
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Acute respiratory failure 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
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diaphragmatic paralysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema 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
Enterostomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Intervertebral disc operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mechanical ventilation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aortic rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arterial thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive urgency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Iliac artery dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Iliac artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
Iliac artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intermittent claudication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Malignant hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Subclavian steal syndrome SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombus SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular access site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View