Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Long-Term (6 Months) Innohep® Treatment Versus Anticoagulation With a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients / IN 0901 INT
Brief Summary: The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.


Options:
A: Inclusion Criteria:

* Confirmed acute lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis
* Active cancer defined as metastatic disease and/or any evidence of cancer on cross-sectional or positron emission tomography (PET) imaging, cancer related surgery, chemotherapy or radiation therapy within the past 6 months; note: non-melanoma skin cancer does not meet the cancer requirement
* Life expectancy \>= 60 days
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Obtained =\< 30 days prior to randomization: Platelet count \>= 50,000/mm\^3
* Obtained =\< 30 days prior to randomization: Alanine aminotransferase (ALT) or aspartate transaminase (AST) =\< 3 x upper limit of normal (ULN)
* Obtained =\< 30 days prior to randomization: International normalized ratio (INR) =\< 1.6 (if not taking anticoagulant therapy)
* Obtained =\< 30 days prior to randomization: Calculated creatinine clearance must be \>= 30 ml/min using the Cockcroft-Gault formula
* Negative serum or urine pregnancy test done =\< 24 hours prior to randomization, for women of childbearing potential only; note: a women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal; menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes
* Ability to complete questionnaire(s) by themselves or with assistance
* Ability to provide informed written consent
* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Exclusion Criteria:

* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential who are unwilling to employ adequate contraception

    * Note: women of child bearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 33 days after finishing the last dose
    * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 93 days after finishing the last dose
    * Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements; however they must still undergo pregnancy testing as described in this section
* Note: investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception; highly effective methods of contraception have a failure rate of \< 1% when used consistently and correctly
* At a minimum, subjects must agree to the use of one method of highly effective contraception as listed below:

  * HIGHLY EFFECTIVE METHODS OF CONTRACEPTION

    * Male condoms with spermicide
    * Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena by WOCBP subject or male subject?s WOCBP partner
    * Female partners of male subjects participating in the study may use hormone based contraceptives as one of the acceptable methods of contraception since they will not be receiving study drug
    * IUDs, such as ParaGard
    * Tubal ligation
    * Vasectomy
    * Complete abstinence

      * Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs; female subjects must continue to have pregnancy tests; acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence
* Treatment with an anticoagulant for more than 7 days for the current blood clot, prior to randomization
* Active bleeding
* Severe hypersensitivity reaction to apixaban, dalteparin, heparin or pork products (e.g., anaphylactic reactions)
* Use of the following CYP3A4 inducers: rifampin, rifabutin, carbamazepine, efavirenz, phenobarbital, phenytoin, fosphenytoin, primidone, and St. John?s wort)
* Thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
* Severe liver disease (known cirrhosis Childs Pugh class B or C), or active hepatitis
* Use of a Factor Xa inhibitor (e.g. apixaban, rivaroxaban, or edoxaban) =\< 3 months prior to randomization
* Treatment of a thromboembolic event =\< 6 months prior to randomization
* Documented venous thromboembolism while on therapeutic anticoagulation (?anticoagulation failure?)
* Mechanical heart valve
* Documented hemorrhagic tendencies
* Bacterial endocarditis
* History of heparin induced thrombocytopenia
* Any of the following conditions:

  * Intracranial bleeding =\< 6 months prior to randomization
  * Intraocular bleeding =\< 6 months prior to randomization
  * Gastrointestinal bleeding and/or endoscopically proven ulcer =\< 6 months prior to randomization
  * Head trauma or major trauma =\<1 month prior to randomization
  * Neurosurgery =\< 2 weeks prior to randomization
  * Major surgery =\< 1 week prior to randomization
  * Overt major bleeding at the time of randomization
  * Gross hematuria at the time of randomization
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:

* A histologic diagnosis of malignancy;
* At planned initiation of a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen);
* A risk score for VTE ≥3 \[assign score of 2 for very high risk sites of cancer (stomach, pancreas), score of 1 for high risk site (lung, lymphoma, gynecologic, bladder, testicular) and score of 0 for all other sites\], hemoglobin \<10 g/dL or planned use of erythropoiesis stimulating agents, platelet count ≥350,000/mm3, total leukocyte count \> 11,000/mm3 or body mass index ≥ 35 kg/m2\]. Any counts meeting criteria drawn within 2 weeks prior to enrollment are considered acceptable.
* Age 18 years or older
* Provide written, informed consent.

Exclusion Criteria:

* Active bleeding or at high risk of serious bleeding complication in the opinion of the investigator
* Diagnosis of primary brain tumor multiple myeloma, leukemia, or myelodysplastic syndrome
* Planned stem cell transplant
* Life expectancy \< 6 months
* Known allergy to heparin or LMWH
* Patient or caregiver incapable of daily self-injection
* Acute or chronic renal insufficiency with creatinine clearance \< 30 mL/min
* History of heparin-induced thrombocytopenia
* Allergy to contrast agents
* Pregnancy
* Need for anticoagulant therapy
* Platelet count \< 75,000/mm3
D: Inclusion criteria:

* Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
* Male or female, being 18 years of age or older
* Written informed consent for study participation

Exclusion criteria:

* Persistent symptoms of VTE
* PE requiring urgent intervention
* Use of vena cava filter
* Contraindications to anticoagulant therapy
* Allergy to study medications
* Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) \> 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
* Severe renal impairment
* Patients considered unsuitable for inclusion

Answer: B