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 @ 7:02 PM
Ignite Modification Date: 2025-12-25 @ 4:36 PM
NCT ID: NCT00561457
Description: None
Frequency Threshold: 1
Time Frame: 2 years
Study: NCT00561457
Study Brief: A Clinical Evaluation of the Bard® Luminexx™ Iliac Stent and Delivery System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Luminexx Iliac Stent and Delivery System Bard® LUMINEXX\* Iliac Stent and the Bard® LUMINEXX\* 6F Iliac Stent systems. None None 57 134 13 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arteriovenous Fistula SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infection (non-sepsis) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Claudication (Non-target limb) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Claudication (Target Limb) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dissection (Target Vessel) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Critical Limb Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Aneurysm (Site Other) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Cerebrovascular Disease SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Colon Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Ischemic Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lumbar Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Myocardial Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Prostatic Hypertrophy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Small Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Valvular Heart Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular Disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Squamous Cell Lung Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Arterial Perforation/Rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
Revascularization Target Limb SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Upper Extremity Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Carotid Artery Disease SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal Complications SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Distal Revascularization (Target Limb) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Revascularization (Non-target Limb) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Angina/Coronary Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arterial Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Target Lesion Revascularization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
False Aneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Amputation on Study Side Limb SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sudden Cardiac Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Angina/Coronary Ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal Complications SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View