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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:00 AM
NCT ID: NCT01925794
Description: None
Frequency Threshold: 5
Time Frame: All-Cause Mortality assessed for 1800 days. Serious and Other Adverse Events assessed for 270 days
Study: NCT01925794
Study Brief: COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
COBRA PzF Stent COBRA PzF Coronary Stent System 34 None 87 296 0 296 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Coronary Artery Thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Myocardial Ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 16.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Gastrooesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Intestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Impaired Healing SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Multi-Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Hepatic Cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16.0 View
Appendicitis Perforated SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Necrotising Fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Nosocomial Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Oophoritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Salpingitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Arterial Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Arterial Restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Coronary Artery Restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Post Pocedural Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Procedural Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Vascular Access Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Blood Creatinine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Cardiac Enzymes Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Electrocardiogram Change SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Bile Duct Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Lung Adenocarcinoma Stage I SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Pleural Mesothelioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Parkinsonian Gait SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Subarachnoid Haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Vascular Dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Calculus Ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Renal Failure Acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Renal Mass SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Arterial Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Intermittent Claudication SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Peripheral Vascular Disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Other Events(If Any):