Adverse Events Module

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

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 @ 12:27 AM

Ignite Modification Date: 2025-12-25 @ 10:32 PM

NCT ID: NCT02365467

Description: None

Frequency Threshold: 0

Time Frame: Adverse Events and All-Cause Mortality through 5 years (05DEC2024)

Study: NCT02365467

Study Brief: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections

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	Subjects who were appropriate candidates for endovascular repair of the Descending Thoracic Aorta (DTA) who require coverage of the left subclavian artery (LSA) and who met the inclusion and exclusion criteria.	9	None	30	32	27	32	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Blood Loss Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Haemorrhagic Arteriovenous Malformation	SYSTEMATIC_ASSESSMENT	Congenital, familial and genetic disorders	None	View
Vertigo	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Abdominal Pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal Pain Upper	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal Haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Ileus	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Upper Gastrointestinal Haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal 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
Stent-Graft Endoleak	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Sudden Cardiac Death	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Systemic Inflammatory Response Syndrome	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Transplant Rejection	SYSTEMATIC_ASSESSMENT	Immune system disorders	None	View
Appendicitis Perforated	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Breast Abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Clostridium Difficile Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Enterococcal Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Folliculitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Post Procedural Haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Procedural Haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Vascular Access Site Complication	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 Haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Vascular Access Site Pseudoaneurysm	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Wound Secretion	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Troponin Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypervolaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Osteoarthritis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Cerebral Haematoma	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Cerebrovascular Accident	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Hydrocephalus	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Ischaemic Stroke	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Normal Pressure Hydrocephalus	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Acute Respiratory Failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dilated Cardiomyopathy	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tooth Abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Renal Cancer	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Ankle Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Iron Deficiency Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Acute Myocardial Infarction	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrial Fibrillation	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
Coronary Artery Stenosis	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ventricular Fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Gastrointestinal Arteriovenous Malformation	SYSTEMATIC_ASSESSMENT	Congenital, familial and genetic disorders	None	View
Furuncle	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Influenza	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Meningitis Bacterial	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Postoperative Wound Infection	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
Anaemia Postoperative	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Arterial Injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Femoral Neck Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	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
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Confusional State	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Delirium	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Acute Kidney Injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Breast Haematoma	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Asthma	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Bronchiectasis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Chronic Obstructive Pulmonary Disease	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Skin Ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Lymphadenectomy	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	None	View
Peripheral Endarterectomy	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	None	View
Aneurysm	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Aortic Aneurysm	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Aortic Aneurysm Rupture	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Aortic Dissection	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Aortic Dissection Rupture	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Haematoma	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Haemorrhage	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertensive Emergency	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Iliac Artery Dissection	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Jugular Vein Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Peripheral Arterial Occlusive Disease	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Peripheral Artery Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Peripheral Ischaemia	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Peripheral Artery Dissection	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hip Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Asthenia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chest Pain	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
Bronchitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Transaminases Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Urine Output Decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Paraesthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Taste Disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Iliac Artery Dissection	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Peripheral Artery Dissection	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Subclavian Artery Aneurysm	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Subclavian Artery Stenosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Venous Stenosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Peripheral Pulse Decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Prostatic Specific Antigen Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Vascular Pseudoaneurysm	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Cardiomegaly	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pericardial Effusion	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sinus Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Abdominal Pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal Haemorrhage	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrooesophageal Reflux Disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haemorrhoids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haemorrhoids Thrombosed	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Clostridium Difficile Colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Influenza	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Nasopharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Postoperative Wound Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Tooth Abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary Tract Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Aortic Pseudoaneurysm	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Contusion	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Incision Site Haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Incision Site Oedema	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post Lumbar Puncture Syndrome	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post Procedural Fever	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post Procedural Haematoma	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Postimplantation Syndrome	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Shoulder Fracture	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
Blood Creatinine Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Body Temperature Increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Electrolyte Imbalance	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Malnutrition	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Back Pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Neck Pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain In Extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Rotator Cuff Syndrome	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Basal Cell Carcinoma	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
Carcinoid Tumour Pulmonary	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Balance Disorder	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Bell's Palsy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Carotid Artery Dissection	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Carpal Tunnel Syndrome	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Cerebrovascular Accident	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dementia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Thrombosis In Device	SYSTEMATIC_ASSESSMENT	Product Issues	None	View
Chronic Kidney Disease	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary Retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Acute Respiratory Failure	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
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Diaphragmatic Disorder	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Emphysema	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
Pruritus	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash Maculo-Papular	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Aneurysm	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Aortic Aneurysm	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertensive Urgency	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hand Fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Angina Unstable	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrial Fibrillation	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrial Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cardiac Failure Chronic	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Blood Loss Anaemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Heparin-Induced Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Iron Deficiency Anaemia	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
Angina Pectoris	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View