Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).
Brief Summary: Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.


Options:
A: Inclusion criteria:

Inclusion_Criteria

* Acute symptomatic deep vein thrombosis (DVT)
* Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

* Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) \> 2x ULN
* Severe renal impairment (estimated creatinine clearance \<= 30 ml/min)
B: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas

  * Patients with clinical 'high probability' of pancreatic cancer and biopsy suggestive but not diagnostic of pancreatic cancer may be eligible based on review by the principal investigator
* Measurable or evaluable disease
* No clinical evidence of active venous thromboembolism

PATIENT CHARACTERISTICS:

* Karnofsky performance status (PS) 60-100% OR WHO PS 0-2
* Life expectancy \> 12 weeks
* Absolute neutrophil count \> 2,000/mm³
* WBC \> 3,000/mm³
* Platelet count \> 100,000/mm³
* Creatinine clearance \> 50 mL/min
* INR ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin \< 1.5 times ULN (stent allowed)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No cerebrovascular accident within the past 6 months
* No obvious contraindication to anticoagulation, including the following:

  * Bleeding diathesis
  * Active peptic ulcer
  * Ulcerating cancer into duodenum
* No history of other advanced malignancy
* No gross hematuria
* No melaena or gross evidence of gastrointestinal bleeding (other than piles)
* No requirement for a central line
* No other significant medial or psychiatric illness that, in the opinion of the investigator, would preclude study participation

PRIOR CONCURRENT THERAPY:

* No prior gemcitabine hydrochloride-containing treatment
* No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications
* No other concurrent specific anticancer therapy as a result of disease progression
* No concurrent caval filter device
* No other concurrent anticoagulants for venous thromboembolism or other reasons (e.g., atrial fibrillation)
* No concurrent acetylsalicylic acid (\> 75 mg) as an antiplatelet drug for a preexisting cardiovascular condition
* No concurrent clopidogrel bisulfate
C: Inclusion Criteria:

* Male or female subjects older than the minimum legal adult age (country specific);
* Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
* Able to provide written informed consent

Exclusion Criteria:

* thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
* More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
* Calculated Creatinine clearance (CrCL) \< 30 mL/min;
* significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) \>\\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
* patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
* active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
* chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
* treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
* concurrent treatment with potent P-gp inhibitors;
* subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study
D: Inclusion Criteria:

* Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
* Other indication for VKA than DVT and/or PE
* The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.

Answer: C