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 @ 7:12 PM
Ignite Modification Date: 2025-12-25 @ 4:47 PM
NCT ID: NCT01069003
Description: None
Frequency Threshold: 5
Time Frame: All events were collected up to 12 months post procedure and only serous adverse events were collected after 12 months
Study: NCT01069003
Study Brief: EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Surveillance Arm Non randomized subjects followed through 24 months None None 664 1451 90 1451 View
Placebo Arm Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA). Placebo (12-Month Arm): Placebo ASA: 75 mg - 325 mg Aspirin(ASA) None None 117 399 0 399 View
Thienopyridine Therapy Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA). Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg ASA: 75 mg - 325 mg Aspirin(ASA) None None 111 412 0 412 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Acute Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiac Enzymes Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Cardiac Failure Congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Coronary Artery Occlusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diabetes Mellitus Inadequate Control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 10.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
In-Stent Coronary Artery Restenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
Peripheral Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Pulmonary Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
Therapeutic Embolisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.0 View
Thrombosis In Device SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Transient Ischaemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Ventricular Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 10.0 View
Atrial Flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Retroperitoneal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View