Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
Brief Summary: The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.


Options:
A: Inclusion criteria

1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation

Exclusion criteria

1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy
5. Patients who in the investigators opinion should not be treated with warfarin
6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
8. Known anaemia
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease
11. Elevated AST or ALT \> 2x ULN
12. Liver disease expected to have any potential impact on survival
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment
15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator
B: Inclusion Criteria:

* Age \> 18 years
* Social security affiliation
* Written informed consent
* Solid active cancer, high grade lymphoma or myeloma treated with Immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide). Active cancer is defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy or targeted therapy at inclusion.
* Histologically or cytologically proven cancer.
* Symptomatic venous thromboembolism objectively confirmed diagnosed because of symptoms or discovered incidentally
* High-risk of recurrent Venous thromboembolism (VTE) defined by a score of 0 or ≥ 1, using the following criteria: female sex (+1), lung cancer (+1), breast cancer (-1) non metastatic tumor (-2), previous VTE (+1).

Exclusion Criteria:

* Exclusive adjuvant hormonal treatment with no measurable residual disease
* Sub-segmental isolated pulmonary embolism (PE) without associated proximal DVT
* Isolated distal deep vein thrombosis (DVT) of the legs
* Isolated upper-extremity DVT or superior vena cava thrombosis
* Isolated visceral thrombosis
* Platelet count \< 50 000 G/L
* Active bleeding
* Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
* Hemostatic defect with contraindication to anticoagulant treatment at therapeutic dosage
* Vena cava filter at inclusion
* Fibrinolytic therapy within 3 days preceding inclusion
* Creatinine clearance \< 30 ml/min according to Cockcroft-Gault formula
* Previous heparin-induced thrombocytopenia
* Anticoagulant treatment at curative dosage for more than 3 days before inclusion
* Pregnancy or lack of effective contraceptive treatment for women of childbearing age
* Treatment with both strong CYP3A4 and P-glycoprotein (PgP) inhibitors: protease inhibitors for HIV disease, systemic ketoconazole
* Treatment with a strong CYP3A4 inducer: rifampicin, carbamazepine, phenytoin.
* Life expectancy \< 3 months
* Eastern Cooperative Oncology Group (ECOG) level 3 or 4
C: Inclusion Criteria:

* Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week

Exclusion Criteria:

* Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance \< 30 mL/min
D: Inclusion Criteria:

* Men and women ≥ 18 years of age;
* Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
* Anticoagulant treatment completed
* No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria:

* Subjects with indications for long-term treatment with a vitamin K antagonist
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Impaired kidney or liver function

Answer: A