A Phase IV, Randomized, Double Blind Study Evaluating the Safety and Efficacy of Apixaban in Subjects With Calf Vein Thrombosis

Number of Subjects Who Experience Either Major Bleeding or Clinically Relevant Non-major Bleeding Within 3 Months

时间窗: Within 3 months of therapy initiation

Major bleeding is defined as overt bleeding plus a hemoglobin decrease of ≥ 2 g/dL or transfusion of ≥ 2 units of packed red blood cells, or bleeding at a critical site: intracranial, intraspinal, intraocular, retroperitoneal, pericardial intra-articular, intramuscular with compartment syndrome, or fatal bleeding. Clinically relevant non-major bleeding is defined as any overt, actionable sign of hemorrhage meeting at least one of the following criteria: (i) requiring nonsurgical, medical intervention by a healthcare professional, (ii) leading to hospitalization or increased level of care, or (iii) prompting evaluation. All patients who received at least one dose of study medication will be included in the safety analysis. All suspected bleeding events will be evaluated by a central, blinded, independent adjudication committee.

Number of Subjects Who Experience a Composite Venous Thromboembolism (VTE) Event Within 3 Months

时间窗: Within 3 months of therapy initiation

The composite VTE event will include thrombus propagation either within the calf veins or into proximal deep veins (popliteal, femoral or iliac veins), symptomatic or incidental VTE recurrence or all-cause mortality within 3 months of therapy initiation. All suspected VTE events will be evaluated by a central, blinded, independent adjudication committee.