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 @ 10:29 PM
Ignite Modification Date: 2025-12-25 @ 8:02 PM
NCT ID: NCT01680835
Description: None
Frequency Threshold: 0
Time Frame: 36 months
Study: NCT01680835
Study Brief: EverFlex Post 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
Study Cohort All patients enrolled in this study were treated with the EverFlex™ Self-Expanding Peripheral Stent System. 8 None 66 108 0 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stenosis SYSTEMATIC_ASSESSMENT General disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Osteomyelitis 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
Compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vascular access site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lumbar spinal stenosis 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
Lip and/or oral cavity cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung 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
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Oesophageal carcinoma 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
Amputation stump pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carotid artery disease SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Genital rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory symptom SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Leg amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Regional chemotherapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Artery dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Intermittent claudication SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ischaemic limb pain SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ischemic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Gangrene SYSTEMATIC_ASSESSMENT General disorders None View
Necrosis SYSTEMATIC_ASSESSMENT General disorders None View
Obstruction SYSTEMATIC_ASSESSMENT General disorders None View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Vascular stent thrombosis SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Genital candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vascular access site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):