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

Withdrawn

• Conditions: Thrombosis, Deep Vein; Pulmonary Embolism

• Registration Number: NCT03812835
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-23
• Study Start: 2021-08-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. 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.

2. Patients (men and women) >18 years old.

3. 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

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Exclusion Criteria

Patients meeting any of the following criteria will not be included in the study:

1. Patients who are participating in a clinical trial.

2. Hypersensitivity to the active substance or to any of the excipients.

3. Active clinically significant bleeding.

4. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, based on hepatic function tests.

5. 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.

6. 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.

7. Pregnancy and breast-feeding.

8. Severe acute or chronic psychiatric condition and other significant medical condition.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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