A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment

Study Overview
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Brief Summary
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Number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.

Official Title
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A PHASE IV NON-INTERVENTIONAL STUDY. REGISTRY OF ADVERSE EVENTS (AES)/SUSPECTED ADVERSE DRUG REACTIONS (SADRS) OF ADULT PATIENTS UNDER TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE); PREVENTION OF RECURRENT DVT AND PE WITH ELICUIS REGISTERED (APIXABAN)

Conditions
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Thrombosis, Deep Vein, Pulmonary Embolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Evidence a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Patients (men and women) >18 years old. Patients who have received at least one dose of apixaban for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE - Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: Patients who are participating in a clinical trial. Hypersensitivity to the active substance or to any of the excipients. Active clinically significant bleeding. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, based on hepatic function tests. Lesion or condition if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. Concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, acenocoumarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy. Pregnancy and breast-feeding. Severe acute or chronic psychiatric condition and other significant medical condition. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico. | Data will be collected for at least 12 months and until 24 months in 3 sites in Mexico using an electronic case report form | 12 up to 24 months |