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 @ 3:49 PM
Ignite Modification Date: 2025-12-25 @ 1:56 PM
NCT ID: NCT01113892
Description: An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).
Frequency Threshold: 5
Time Frame: One Year
Study: NCT01113892
Study Brief: Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EXXCEL Soft Patients who were enrolled and treated with the EXXCEL Soft vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received. 2 None 50 101 14 101 View
FUSION Bioline Patients who were enrolled and treated with the FUSION Bioline vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received. Note that one patient was randomized to the Fusion Bioline group but received the FUSION graft in error. 4 None 44 105 24 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vascular graft thrombosis / Vascular graft occlusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Graft haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural myocardial infarction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Vascular graft complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Abscess limb NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gangrene NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Haematoma infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection enterococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection pseudomonas NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Intermittent claudication NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphocele NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral artery dissection NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Hernia obstructive NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Medical device complication NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Arterial bypass operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Foot amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Carotid endarterectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Debridement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Peripheral artery angioplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Skin graft NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Toe amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Embolic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intracranial aneurysm NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Retroperitoneal haematoma NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Soft tissue necrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Renal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Penile oedema NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Acute respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Implant site effusion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Impaired healing NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Psychiatric decompensation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Anaemia postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Anastomotic stenosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Vascular procedure complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Graft infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Peripheral ischaemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Femoral arterial stenosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Arterial stenosis limb NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Ventricular arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia postoperative NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Impaired healing NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View