Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

Inclusion Criteria:

- Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or
unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a
segmental or more proximal pulmonary artery;

- Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin,
primary brain tumor or intracerebral metastasis and acute leukemia);

- Signed and dated informed consent of the patient, available before the start of any
specific trial procedure.

Exclusion Criteria:

- age <18 years;

- ECOG Performance Status III or IV;

- life expectancy of less than 6 months;

Related to anticoagulant treatment:

- administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin
(UFH) for more than 72 hours before randomization;

- 3 or more doses of a vitamin K antagonist before randomization;

- thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index
episode;

- indication for anticoagulant treatment for a disease other than the index VTE episode;

Related to bleeding risk:

- thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg
daily or dual antiplatelet therapy;

- active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;

- recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic
surgery

- hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count <75x10^9/L or
history of heparin induced thrombocytopenia;

- creatinine clearance < 30 ml /min based on the Cockcroft Gault equation;

- acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine
aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher
the upper limit of the normal range;

- uncontrolled hypertension (systolic BP> 180 mmHg or diastolic BP > 100 mmHg despite
antihypertensive treatment);

- concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and
P-Glycoprotein;

Standard criteria:

- bacterial endocarditis;

- hypersensitivity to the active substance or to any of the excipients of study drug;

- patients participation in other pharmaco therapeutic program with an experimental
therapy that is known to effect the coagulation system;

- childbearing potential without proper contraceptive measures, pregnancy, or breast
feeding;

- any condition that as judged by the Investigator would place the subject at increased
risk of harm if he/she participated in the study.