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 @ 12:35 AM

Ignite Modification Date: 2025-12-25 @ 10:44 PM

NCT ID: NCT01685567

Description: None

Frequency Threshold: 0

Time Frame: None

Study: NCT01685567

Study Brief: Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Intention-to-Treat (ITT)	All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.	None	None	29	219	118	219	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Pneumonia	None	Infections and infestations	None	View
Bradycardia	None	Cardiac disorders	None	View
Cerebrovascular Accident	None	Nervous system disorders	None	View
Acute Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Anaemia	None	Blood and lymphatic system disorders	None	View
Myocardial Infarction	None	Cardiac disorders	None	View
Gastrointestinal Haemorrhage	None	Gastrointestinal disorders	None	View
Pyrexia	None	General disorders	None	View
Wound Haematoma	None	Injury, poisoning and procedural complications	None	View
Angina Pectoris	None	Cardiac disorders	None	View
Cardiac Arrest	None	Cardiac disorders	None	View
Cardiac Failure Acute	None	Cardiac disorders	None	View
Post Procedural Cellulitis	None	Infections and infestations	None	View
Incision Site Haematoma	None	Injury, poisoning and procedural complications	None	View
Troponin Increased	None	Investigations	None	View
Diabetic Ketoacidosis	None	Metabolism and nutrition disorders	None	View
Ischaemic Stroke	None	Nervous system disorders	None	View
Metabolic Encephalopathy	None	Nervous system disorders	None	View
Psychomotor Seizures	None	Nervous system disorders	None	View
Renal Failure	None	Renal and urinary disorders	None	View
Urinary Retention	None	Renal and urinary disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Aortic Aneurysm	None	Vascular disorders	None	View
Artery Dissection	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Hypertension	None	Vascular disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Hypokalaemic Syndrome	None	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	None	Metabolism and nutrition disorders	None	View
Hypophosphataemia	None	Metabolism and nutrition disorders	None	View
Carotid Artery Stenosis	None	Nervous system disorders	None	View
Cerebrovascular Accident	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Ischaemic Stroke	None	Nervous system disorders	None	View
Metabolic Encephalopathy	None	Nervous system disorders	None	View
Psychomotor Seizures	None	Nervous system disorders	None	View
Hallucination, Visual	None	Psychiatric disorders	None	View
Dysuria	None	Renal and urinary disorders	None	View
Hematuria	None	Renal and urinary disorders	None	View
Renal Failure	None	Renal and urinary disorders	None	View
Urinary Retention	None	Renal and urinary disorders	None	View
Acute Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Dysphonia	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pneumothorax	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary Embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Rales	None	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory Failure	None	Respiratory, thoracic and mediastinal disorders	None	View
Rhinorrhoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Throat Irritation	None	Respiratory, thoracic and mediastinal disorders	None	View
Wheezing	None	Respiratory, thoracic and mediastinal disorders	None	View
Dermatitis Allergic	None	Skin and subcutaneous tissue disorders	None	View
Ecchymosis	None	Skin and subcutaneous tissue disorders	None	View
Skin Irritation	None	Skin and subcutaneous tissue disorders	None	View
Therapy Regimen Changed	None	Surgical and medical procedures	None	View
Aortic Aneurysm	None	Vascular disorders	None	View
Artery Dissection	None	Vascular disorders	None	View
Hemorrhage	None	Vascular disorders	None	View
Hematoma	None	Vascular disorders	None	View
Hypertension	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Orthostatic Hypotension	None	Vascular disorders	None	View
Vascular Occlusion	None	Vascular disorders	None	View
Device Occlusion	None	General disorders	None	View
Ventricular Extrasystoles	None	Cardiac disorders	None	View
Ear Pain	None	Ear and labyrinth disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Dysphagia	None	Gastrointestinal disorders	None	View
Gastrointestinal Hemorrhage	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Chest Discomfort	None	General disorders	None	View
Oedema	None	General disorders	None	View
Pain	None	General disorders	None	View
Pyrexia	None	General disorders	None	View
Vessel Puncture Site Haematoma	None	General disorders	None	View
Allergy To Arthropod Bite	None	Immune system disorders	None	View
Acute Sinusitis	None	Infections and infestations	None	View
Adenoviral Upper Respiratory Infection	None	Infections and infestations	None	View
Bronchitis	None	Infections and infestations	None	View
Herpes Zoster	None	Infections and infestations	None	View
Infection	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Post Procedural Cellulitis	None	Infections and infestations	None	View
Rash Pustular	None	Infections and infestations	None	View
Upper Respiratory Tract Infection	None	Infections and infestations	None	View
Urinary Tract Infection	None	Infections and infestations	None	View
Cranial Nerve Injury	None	Injury, poisoning and procedural complications	None	View
Incision Site Haematoma	None	Injury, poisoning and procedural complications	None	View
Vascular Injury	None	Injury, poisoning and procedural complications	None	View
Wound Haematoma	None	Injury, poisoning and procedural complications	None	View
Wound Secretion	None	Injury, poisoning and procedural complications	None	View
Blood Creatine Phosphokinase Increased	None	Investigations	None	View
Oxygen Saturation Decreased	None	Investigations	None	View
Troponin Increased	None	Investigations	None	View
Dehydration	None	Metabolism and nutrition disorders	None	View
Diabetic Ketoacidosis	None	Metabolism and nutrition disorders	None	View
Hyperglycaemia	None	Metabolism and nutrition disorders	None	View
Hypernatraemia	None	Metabolism and nutrition disorders	None	View
Hypokalaemia	None	Metabolism and nutrition disorders	None	View
Sinus Bradycardia	None	Cardiac disorders	None	View
Tachycardia	None	Cardiac disorders	None	View
Anaemia	None	Blood and lymphatic system disorders	None	View
Thrombocytopenia	None	Blood and lymphatic system disorders	None	View
Angina Pectoris	None	Cardiac disorders	None	View
Atrial Fibrillation	None	Cardiac disorders	None	View
Bradycardia	None	Cardiac disorders	None	View
Cardiac Arrest	None	Cardiac disorders	None	View
Cardiac Failure Acute	None	Cardiac disorders	None	View
Myocardial Infarction	None	Cardiac disorders	None	View