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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT00766493
Description: None
Frequency Threshold: 4
Time Frame: 30 days
Study: NCT00766493
Study Brief: GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
EMBOLDEN GORE® Embolic Filter with carotid artery stenting None None 56 250 83 250 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood & Lymphatic System - Other SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina/coronary ischemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Asystole SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac - Other SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction (MI) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombosis/Occlusion - GEF SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Gastrointestinal - Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retroperitoneal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Groin Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infection at access site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Metabolism & Nutrition - Other SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Musculoskeletal and Connective Tissue - Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nervous System - Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral ischemia/transient ischemic attack (TIA) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Visual disturbance SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stroke/cerebrovascular accident (CVA) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal failure/insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal & Urinary - Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
COPD, worsening of SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel spasm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vascular - Other SYSTEMATIC_ASSESSMENT Vascular disorders None View
Ischemia/Infarction of tissue/organ SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel dissection, perforation or rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
Not Elsewhere Classified - Other SYSTEMATIC_ASSESSMENT General disorders None View
Congestive Heart Failure (CHF) - onset or worsening of SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Respiratory, Thoracic & Mediastinal - Other SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervous System - Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding SYSTEMATIC_ASSESSMENT Vascular disorders None View