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 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:19 AM
NCT ID: NCT03119233
Description: Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the medical device. This includes events related to the study device or events related to the procedures involved.
Frequency Threshold: 3
Time Frame: All Adverse Events will be collected through 12 month follow-up. SAEs, MAEs and UADEs will be collected for the duration of the study. All device- and procedure-related events, all target limb related events, and all potential non-serious events related to study requirement medications shall be reported throughout the trial.
Study: NCT03119233
Study Brief: The DETOUR 2 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
All Subjects All Subjects Intent to Treat (ITT) 14 None 130 202 142 202 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Organ failure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Coronary artery stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
left ventricular failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Diabetic foot NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.1 View
Diabetic ketoacidosis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.1 View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Femoral artery dissection NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Haemorrhagic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Lymphoma NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Microcytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Acute coronary syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Arteriospasm coronary NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Atrial tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Cardiac failure acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Ischaemic cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Ventricular fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Ventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Diabetes mellitus inadequate control NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 21.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Gastroenteritis viral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Pyloric stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Stomal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Umbilical hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Vascular stent occlusion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Vascular stent stenosis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Anaemia postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Atheroembolism NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Burns second degree NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Femoral artery peforation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Post procedural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Procedural hypotension NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Respiratory fume inhalation disorder NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Rib fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Stoma complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Tibia fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Vascular access site maematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Vascular access site haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Vascular pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Wound secretion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Troponin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Ultrasound Doppler abnormal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.1 View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hyperinsulinaemic hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypocalcaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 21.1 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Osteonecrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Pelvic fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Upper limb fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Adenomatous polyposis coli NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Bronchial carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Dermal cyst NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Laryngeal cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Lung adenocarcinoma stage IV NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Lung cancer metastatic NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Metastases to liver NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.1 View
Cerebellar stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Thoracic spinal stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Thrombotic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Device dislocation NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA 21.1 View
Device malfunction NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA 21.1 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 21.1 View
Benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.1 View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.1 View
Angioplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.1 View
Toe amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 21.1 View
Anaphylactic shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Aortic aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Arterial bypass stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Arterial stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Arteriovenous fistula NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Cerebellar haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Circulatory collapse NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Compartment syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Device embolisation NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Femoral artery embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Haemorrhage intracranial NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypertensive emergency NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypovolaemic shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Intermittent claudication NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Ischaemic limb pain NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Pelvic haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral arterial occlusive disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery restenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral ischaemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral vascular disorder NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Pharyngeal haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Retroperitoneal haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Vascular stent occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Vascular stent stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Vascular stent thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 21.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Vascular access site haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral venous disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Vascular stent occlusion NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Vascular stent stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View
Peripheral artery stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.1 View