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

Last updated on May 29, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Deep Vein Thrombosis, Pulmonary Embolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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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NCT03812835
Pfizer
Not yet recruiting
A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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