A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism Revised Protocol Number: 01, Incorporates amendment(s) 02 + Protocol Amendment 01 (version 1.0 dated 21-Apr-08) Site-specific - Molecular Profiling Supplement Samples For Pfizer’s Exploratory Research Biobank

INTERVENTION: Product Name: Apixaban Product Code: BMS‐562247‐01 Pharmaceutical Form: Film‐coated tablet CAS Number: 503612‐47‐3 Current Sponsor code: BMS‐562247‐01 Other descriptive name: Apixaban Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Lovenox Product Name: Lovenox Product Code: Enoxaparin sodium Pharmaceutical Form: Solution for injection INN or Proposed INN: Enoxaparin sodium Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Lovenox Product Name: Lovenox Product Code: Enoxaparin sodium Pharmaceutical Form: Solution for injection INN or Proposed INN: Enoxaparin sodium Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Trade Name: Coumadin Product Name: Coumadin Product Code: Warfarin Sodium Pharmaceutical Form: Tablet INN or Proposed INN: Warfarin Sodium CAS Number: 129‐06‐6 Current Sponsor code: BMS‐565793 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Coumadin Product Name: Coumadin Product Code: Warfarin Sodium Pharmaceutical Form: Tablet INN or Proposed INN: Warfarin Sodium CAS Number: 129‐06‐6 Current Sponsor code: BMS‐565793 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Trade Name: Coumadin Product Name: Coumadin Product Code: Warfarin Sodium Pharmaceutical Form: Tablet INN or Proposed INN: Warfarin Sodium CAS Number: 129‐06‐6 Current Sponsor code: BMS‐565793 Concentration unit: mg CONDITION: Venous Thromboembolism (VTE) ; MedDRA version: 9.1 Level: PT Classification code 10051055 Term: Deep vein thrombosis ; MedDRA version: 9.1 Level: PT Classification code 10037377 Term: Pulmonary embolism PRIMARY OUTCOME: Main Objective: To determine if apixaban is non‐inferior to standard enoxaparin/warfarin therapy in the combined endpoint of adjudicated recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE‐related death over 6 months of therapy. Primary end point(s): The following outcomes will be examined:; ‐ The primary efficacy outcome: the incidence of an adjudicated composite of recurrent symptomatic VTE or VTE‐related death during 6 months of therapy.; ‐ The primary safety outcome: the incidence of adjudicated major bleeding during the treatment period.; ‐ Secondary Efficacy Endpoints: the incidence of:; • adjudicated composite of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) and all‐cause death; • adjudicated composite of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) and CV death; • adjudicated composite of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE), VTE‐related death and major bleeding; • adjudicated symptomatic nonfatal DVT; • adjudicated symptomatic nonfatal PE; • adjudicated VTE‐related death; • adjudicated CV death; • all‐cause death.; ‐ Secondary Safety Endpoints: the incidence of:; • an adjudicated composite of major and clinically relevant non‐major bleeding; Other safety outcome measures will also be assessed, including adjudicated minor bleeding, adjudicated total bleeding, serious and non‐serious AEs, and changes in standard clinical laboratory test results.; ‐ Other Endpoints:; Estimates of apixaban population pharmacokinetic parameters. Secondary Objective: a) To determine if apixaban is superior to standard enoxaparin/warfarin therapy in the combined endpoint of adjudicated recurrent symptomatic VTE or ; • VTE‐related death over 6 months of therapy; • All‐cause death over 6 months of therapy; b) To characterize apixaban therapy relative to standard enoxaparin/warfarin therapy: ; • in the combined endpoint of adjudicated recurrent symptomatic VTE or cardiovascular death over 6 months of therapy; • in the combined endpoint of adjudicated recurrent symptomatic VTE , VTE‐related death, or major bleeding over 6 months of therapy; • in adjudicated major bleeding during 6 months of therapy; • in the composite of adjudicated major bleeding and adjudicated clinically relevant nonmajor bleeding during 6 months of therapy; c) To characterize the primary efficacy outcome in the subset of subjects with index; events of DVT only and in the subset of subjects with index events of PE with or; without DVT. INCLUSION CRITERIA: a) Acute symptomatic proximal DVT with evidence of proximal thrombosis that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with: ‐ compression ultrasound (CUS), including grey‐scale or color‐coded Doppler, or ‐ ascending contrast venography. Or b) Acute symptomatic PE with evidence of thrombosis demonstrated by imaging as follows: ‐ an intraluminal filling defect in segmental or more proximal branches on spiral CT scan; or ‐ an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or ‐ a perfusion defect of at least 75% of a segment with a local normal ventilation result (high‐probability) on ventilation/perfusion lung scan (VPLS). c) Men and women, ages 18 years or greater. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk o