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)

Pfizer0 sitesAugust 23, 2021

ConditionsThrombosis, Deep Vein Pulmonary Embolism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Thrombosis, Deep Vein
Sponsor: Pfizer
Primary Endpoint: The number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.
Status: Withdrawn
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 23, 2021

End Date

August 23, 2023

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.

Time Frame: 12 up to 24 months

Data will be collected for at least 12 months and until 24 months in 3 sites in Mexico using an electronic case report form