Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer
Brief Summary: The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.


Options:
A: Inclusion Criteria:

* Male or female subjects with age ≥ 18 years or the otherwise legal lower age according to the country of residence;
* Confirmed acute lower extremity proximal DVT or PE for which long term treatment with low molecular weight heparin (LMWH) is indicated;
* Cancer, other than basal-cell or squamous-cell carcinoma of the skin;
* Able to provide written informed consent.

Exclusion Criteria:

* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
* Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
* Active bleeding or high risk for bleeding contraindicating treatment with LMWH or edoxaban;
* Any other contraindication listed in the local labeling of dalteparin, enoxaparin, or edoxaban;
B: Inclusion Criteria:

* Patients with a diagnosis of active cancer.
* Symptomatic and objectively confirmed VTE.
* ≥ 18 years of age or above the legal age of consent as per country specific regulations.
* Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2.
* Signed informed consent.

Exclusion Criteria:

* Life expectancy \< 6 months.
* Patients with basal cell carcinoma or non-melanoma skin cancer.
* Creatinine clearance ≤ 20 ml/min.
* Contra-indications to anticoagulation.
* Known hypersensitivity to the investigational product (Innohep®) or the reference product (warfarin).
* History of heparin-induced thrombocytopenia (HIT).
* Pre-randomisation therapeutic anticoagulant treatment for acute VTE administered for more than 72 hours prior to randomisation.
* Patients unlikely to comply with the protocol.
* Participation in another interventional study.
* Pregnant or breast-feeding women.
* Women of childbearing potential.
C: Inclusion criteria:

1. Patients with confirmed symptomatic PE or proximal DVT of the leg(s) who have been treated for 6 to 18 months with therapeutic dosages (intended INR between 2-3) of an oral VKA (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or RE-COVER study medication up to the moment of screening for the current study.
2. Written informed consent

Exclusion criteria:

1. Younger then 18 years of age
2. Indication for VKA other than DVT and/or PE
3. Patients in whom anticoagulant treatment for their index PE or DVT should be continued
4. Active liver disease or liver disease decreasing survival (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT \> 3 x ULN
5. Creatinine clearance \< 30 ml/min
6. Acute bacterial endocarditis
7. Active bleeding or high risk for bleeding.
8. Uncontrolled hypertension (investigators judgement)
9. Intake of another experimental drug within the 30 days prior to randomization into the study
10. Life expectancy \<6 months
11. Childbearing potential without proper contraceptive measures\*, pregnancy or breast feeding
D: Inclusion Criteria Patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy

Exclusion Criteria:

* Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy
* Previous DVT or venous thromboembolism
* Administration of LMWH or unfractionated heparin before randomization
* Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)
* Thrombocytopenia (platelets \<100 x 109L)
* Severe chronic kidney disease (estimated glomerular filtration rate \<30 ml/minute)
* Pregnant women

Answer: A