Please select the eligibility criteria that correspond to the clinical trial below.
Title: Apixaban for the Prevention of Venous Thromboembolism in High-Risk Ambulatory Cancer Patients: A Randomized Placebo-Controlled, Double-Blind Clinical Trial
Brief Summary: Cancer patients have an increased risk of developing blood clots in the veins compared to non-cancer patients. Cancer patients who develop blood clots can lead to reduced life expectancy, delayed cancer treatment, and decreased quality of life. Prevention is the most effective way to decrease the complications associated with blood clots in the veins. Although previous clinical trials have shown some benefit on the use of medication to prevent blood clots in the veins in ambulatory cancer patients, these studies have been inconclusive in demonstrating that existing blood thinners significantly reduce the rate of blood clots in cancer patients. One possible explanation relates to the fact that these studies have included a large proportion of cancer patients who are a low risk of developing blood clots in the veins. We are proposing to identify cancer patients who are at a high risk of developing blood clots by using a validated tool at the time of their cancer diagnosis. The identified high risk cancer patients will be asked to participate in a trial to test the safety and efficacy of a new oral medication that has been used to prevent blood clots in patients undergoing surgery. We are enrolling 574 patients in 7 Canadian centers (Ottawa, Halifax, Montreal, Vancouver, Sault Ste. Marie, Toronto and Hamilton). 287 patients will receive the study drug and 287 will receive an inactive substance. Analysis will be performed to assess the safety and the superiority of the study drug.


Options:
A: Inclusion Criteria:

* A newly diagnosed cancer site or progression of the malignant disease after complete or partial remission.
* Initiating a new course of chemotherapy with a minimum intent of 3 months therapy
* A VTE risk stratification score of ≥ 2, according to the scoring method
* Age 18 years old or older
* Provide written informed consent

Exclusion Criteria:

* Lesions or conditions at increased risk of clinically significant bleeding (eg. active peptic ulcer disease)
* Objectively confirmed substantial liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including hypoalbuminemia (\< 3.5 gr/dL), elevated levels of total bilirubin (\> 25 umol/L), elevated liver transaminases (2 times the upper limit of normal) and/or biochemical diagnosis of biliary tract obstruction (elevated levels of gamma-glutamyl transferase and alkaline phosphatase, 3 times the upper limit of normal). \*
* Diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome\*\*
* Planned stem cell transplant
* Life expectancy less than 6 months
* Acute or chronic renal insufficiency with glomerular filtration rate (GFR) \< 30 ml/min calculated by the Cockroft and Gault formula.
* Pregnancy\*\*\*
* Continuous anticoagulation with vitamin K antagonists, low-molecular-weight heparin (LMWH), or other oral anticoagulants
* Weight \< 40 Kg
* Platelet count \< 50 x 109/L
* Known allergies to ingredients contained in apixaban
* Use of any contraindicated medications with apixaban
B: DISEASE CHARACTERISTICS:

* Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks
* No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site)
* No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Platelet count ≥ 100,000/mm³
* Serum creatinine ≤ 150 µmol/L
* Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver
* Not pregnant or nursing
* Fertile female patients must use effective contraception (if sexually active)
* No hemorrhagic stroke within the past 3 months
* No known bleeding disorder
* No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention)
* No central venous catheter requiring the use of thromboprophylaxis
* No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis)
* No prior illness likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

* No prior treatment likely to interfere with study treatment or comparisons
* More than 12 months since prior and no concurrent therapeutic anticoagulation
* No concurrent ketorolac (Toradol®)
C: Inclusion Criteria:

Patients with completely resected non-small cell lung cancer of stage I, II, or IIIA T3N1 confirmed by histology can be included in the study Patients who had preoperative chemotherapy, those who are selected for adjuvant chemotherapy and those who are not candidates for adjuvant chemotherapy (because they have a contraindication to chemotherapy or they have a stage I cancer) are eligible for the study Written informed consent age \> 18 years

Exclusion Criteria:

Previous heparin induced thrombocytopenia Allergy to tinzaparin Allergy to sulfites Renal failure with a creatinin clearance \< 30 ml/min according to COCKROFT formula Prothrombin time \< 50% Platelet count \< 100 G/L Increased bleeding risk: ongoing hemorrhage, major bleeding within 10 days, previous intracerebral bleeding, uncontrolled hypertension (SAP \> 180 mmHg or DAP \> 120 mmHg) Indication for curative anticoagulant treatment on inclusion More than 6 weeks between surgery and inclusion Known pregnancy or no efficient contraception for women of childbearing age Breast feeding Previous malignant disease diagnosed within 2 years except in situ carcinoma of the uterine cervix or spinal-cellular or baso-cellular cutaneous carcinoma Inclusion in another therapeutic trial at the time of inclusion Treatment with an experimental drug within 30 days before inclusion in the study
D: Inclusion Criteria:

* Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Have a Khorana thromboembolic risk Score greater than or equal to (\>=) 2
* Creatinine clearance (CrCl) \>= 30 milliliter per minute (mL/min)
* Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care

Exclusion Criteria:

* Diagnosis of primary brain tumors
* Known history of brain metastases
* Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
* Hematologic malignancies with the exception of lymphoma
* Platelet count less than (\<) 50,000/millimeter\^3 (mm\^3), Life expectancy of less than or equal to (\<=) 6 months

Answer: A