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 @ 2:24 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT02887859
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02887859
Study Brief: Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HAV Treatment Human Acellular Vessel (HAV) Human Acellular Vessel (HAV): Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques 1 None 11 15 15 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Impaired healing, Oedema peripheral, Pain, Vascular stent restenosis SYSTEMATIC_ASSESSMENT General disorders None View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pleural effusion, Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Arterial insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anastomic stenosis, Arterial bypass stenosis, Arterial bypass thrombosis, continued in description SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hyperglycaemic hyperosmolar nonketotic syndrome SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Angina pectoris, Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Implant site extravasation, Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post procedural swelling, Seroma, Vascular pseudoaneurysm thrombosis, Wound decomposition SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulse absent, Scan myocardial perfusion abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Gout, Hyperuricaemia, Vitamin B12 deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia, Back pain, Muscle necrosis, Musculoskeletal pain, Pain in extremity, Tenosynovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness, Headache, Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety, Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough, Pleural effusion, Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis, Skin hyperpigmentation, Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arterial stenosis, Haematoma, Intermittent claudication, Continued in description SYSTEMATIC_ASSESSMENT Vascular disorders None View