Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 2 weeks prior to registration: Subject has prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 x the laboratory upper limit of normal (ULN)

International normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history

Prothrombin time (PT)/ international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN

Patients must have the following tests within 28 days prior to registration to obtain baseline measurements:\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)/fibrinogen (all patients)\r\n* Neurologic assessment

Within 10 days of treatment initiation: Prothrombin time (PT) and partial thromboplastin time (aPTT) =< 1.5 X institutional upper limit of normal (IULN)

Within 21 days of treatment initiation:\r\nInternational normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x upper limit of normal (ULN); subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization

PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN

Partial thromboplastin time (PTT) / prothrombin time (PT) =< 1.5 x ULN or international normalized ratio (INR) < 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.

Prothrombin time, international normalized ratio (INR), and/or activated partial thromboplastin time within =< 1.5 x ULN (for treatment phase)

International Normalized Ratio (INR) or Prothrombin Time (PT) ?1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 14 days of treatment initiation)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT/INR/ partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants obtained within 14 days prior to registration

Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (up to 14 days before treatment initiation)

International normalized ratio (INR)/ prothrombin time (PT) =< 1.5 x institutional ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN

Within 14 days of treatment initiation:\r\nInternational normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Any of the following abnormal laboratory values (unless due to underlying lymphoma): International normalized ratio (INR) or prothrombin time (PT) >1.5*upper limit of normal (ULN) in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) >1.5*ULN in the absence of a lupus anticoagulant

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Patients must have adequate coagulation function as evidenced by prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) within normal institutional limits

International normalized ratio (INR)/prothrombin time (PT) =< 1.5 times ULN unless participant is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

FOR SECOND-LINE THERAPY ONLY: Prothrombin time and partial thromboplastin time (PTT) must be =< 2 X the upper limit of the institution's normal range and INR (international normalized ratio) < 2; subjects on anticoagulation (such as coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation

COHORT 1: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation

COHORT 2: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 2 times normal; timeline: within 3 weeks prior to enrollment or

SAFETY RUN-IN: Within 10 days of registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

RANDOMIZED PHASE II CLINICAL TRIAL: Within 10 days of registration: International normalized ratio (INR) or PT =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ?1.5 times ULN)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR)* =< 1.3 x upper limit of normal (ULN)\r\n* Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization; PT and partial thromboplastin time (PTT) > 1.5 x ULN are permitted in these subjects

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of cabozantinib

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN)

Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control

Prothrombin time (PT) / partial thromboplastin time (PTT); PT such that international normalized ratio (INR) =< 1.5 x ULN (unless a patient is on therapeutic warfarin) or a PTT =< 1.5 x ULN

Abnormal coagulation profile (PT or INR, PTT) > 1.3x ULN

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant.

Within 10 (except as noted) days of planned treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN, unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN unless subject is receiving anticoagulation therapy as long as PT or INR is within therapeutic range of intended use of anticoagulant within 28 days of treatment initiation and must be independent of hematopoietic growth factor support

International normalized ratio or prothrombin time =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.

Prothrombin time (PT)/partial thromboplastin time (PTT) ? 1.2 × ULN (unless receiving anticoagulation therapy, if receiving anticoagulation therapy, eligibility will be based upon international normalized ratio [INR]).

Partial thromboplastin (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit

Obtained within 28 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5

International normalized ratio (INR) or prothrombin rime (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Within 14 days of treatment registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) < 1.5 times the upper limit of normal unless subject is receiving anticoagulant therapy, as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants

INCLUSION - PROCUREMENT: If pheresis required to collect blood\r\n* Prothrombin time (PT) and activated partial thromboplastin time (APTT) <1.5 × upper limit normal

For patients with planned deep tumor injections: prothrombin time (PT), activated partial thromboplastin time (aPPT), and international normalized ratio (INR) within normal limits; Platelet count ?100,000/?L; hemoglobin ? 9 gm/dL.

International normalized ratio (INR) or prothrombin time (PT) < 1.5 times the upper limit of normal unless subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin and a partial thromboplastin time (PTT) =< upper limit of normal

Adequate Coagulation defined as prothrombin time (PT) and partial thromboplastin time (PTT) <= 1.2 x upper limit of normal and an international normalized ratio (INR) <= 1.2.

The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ?1.5 × ULN

International normalized ratio (INR) or prothrombin time (PT) < 1.5 times the upper limit of normal unless subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN

International normalized ratio (INR) ? 1.5 and partial thromboplastin time (PTT) ? 1.5 x ULN. Prothrombin time (PT) may be used instead of INR if ? 1.5 x ULN.

PT and PTT <1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation

Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (for patients on warfarin, INR should be maintained within therapeutic limits (either 2-3 or 2.5-3.5 for heart valve patients)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation

Prothrombin time/International Normalized Ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants or patient has disseminated intravascular coagulation deemed by investigator to be due to leukemia, performed within 14 days of D1 of treatment under LCCC1522

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (performed within 28 days of treatment initiation)

International normalized ratio (INR) ?1.5 or prothrombin time (PT) ?1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ?1.5 × ULN.

The patient has adequate coagulation: prothrombin time (PT) and an International Normalized Ratio (INR), and partial thromboplastin time (PTT) ? 1.5 times the upper limit of normal (ULN),

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 28 days of study registration

Prothrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%

International normalized ratio (INR) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

PT and PTT w/in ?1.5× ULN

PHASE I: Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) =< 1.5 x ULN

Prothrombin time (PT) or international normalize rate (INR) within 1.5x upper limit of normal;

Partial thromboplastin time (PTT) within 1.5x upper limit of normal;

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) > 1.5 times the upper limit of normal

Prothrombin time (PT/international normalized ratio [INR]) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range at baseline

PART I: Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x the upper limits of normal

Prothrombin Time (PT) and activated partial thromboplastin time (aPTT) <= 1.5x the upper limit of normal.

Normal prothrombin time (PT)

Partial thromboplastin time (PTT) at enrollment per institutional range

Prothrombin time (PT)/partial thromboplastin time (PTT) > 1.5 upper limit of normal (ULN)

Performed within 10 business days of treatment initiation with the exception of beta- HCG (72 hours), if applicable: International normalized ratio (INR) or prothrombin time (PT) =<1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants.

Subject has prothrombin time/International Normalized Ratio or partial thromboplastin time test results at screening ?1.5 x ULN.

Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)

Prothrombin time (PT)/partial thromboplastin time (PTT) less than 1.5 times normal

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation

Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, should be performed within 10 days of treatment initiation

Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Prothrombin time (PT) & activated partial thromboplastin time (aPTT) =< 1.5 X ULN (correction with vitamin K allowed) unless subject is\r\nreceiving anticoagulant therapy (which should be managed according to institutional norms prior to and after excisional biopsy).

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULN

If not receiving anticoagulants: international normalized ratio (INR) OR prothrombin (PT) =< 1.5 x ULN, performed within 14 days prior to day 1 of protocol therapy\r\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 21 days of treatment initiation

Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normal

Prothrombin time (PT) ?1.5 × ULN (Grade ?1).

International normalized ratio or prothrombin time =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 21 days of treatment initiation

Performed within 10 days of treatment initiation: international normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN

Should be performed within 30 days of treatment initiation: international normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 28 days of cycle 1 day 1: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving\r\nanticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)

Within 5 days prior to the start of study treatment: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.

Adequate coagulation function as defined by International Normalized Ratio ?1.5 or prothrombin time ?1.5 x ULN, and partial thromboplastin time ?1.5 x ULN

Activated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN)

Coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN

Prothrombin time (PT)/ international normalized ratio (INR), partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN)

Prothrombin time (PT)/ international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 28 days before the first dose of study treatment.

Prothrombin time (PT) > 16.5 seconds or

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) and/or prothrombin time international normalized ratio (PT-INR) and/or activated partial thromboplastin time (APTT) =< 1.3 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation

International normalized ratio (INR) or prothrombin rime (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Coagulation international normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.

To be performed within 14 days of treatment initiation: international normalized ratio (INR) or prothrombin time (PT) ? 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation

Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test =< 1.5 x ULN

Prothrombin time (PT)/partial thromboplastin time (PTT) ? 1.5 times the ULN

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =<1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range on intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.

Within 7 days of registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants

Obtained =< 14 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN).

Within 10 days prior to on-study date: International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) no more than 2 seconds above the upper limits of normal (ULN)

Prothrombin time (PT)/institutional normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use on anticoagulant

Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 7 days (+ 3 day window) of enrollment: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x the institutional upper limit of normal (ULN), (this will not apply to subjects with confirmed Factor XII deficiency)

Within 7 days before the first dose of study treatment: Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test < 1.3 x the ULN within 7 days before the first dose of study treatment

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Prothrombin time (PT) and partial thromboplastin time (PTT) must be =< 2 x the upper limit of the institution's normal range, at the time of enrollment

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder).

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatment

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and activated partial thromboplastin time (aPTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)

Obtained =< 28 days prior to registration: Prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless patient is receiving anticoagulant therapy and PT or partial prothrombin time (PTT) is within therapeutic range of intended use of coagulants

Performed within 7 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Performed within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT)\r\nactivated partial thromboplastin time (aPTT) =< 1.5 X ULN; if on active anticoagulants prior to study treatment, levels must be within standard therapeutic ranges per investigator

International Normalized Ratio (INR) or Prothrombin Time (PT) ?1.5 times the ULN and Activated Partial Thromboplastin Time (aPTT) ?1.5 times the ULN. Note: If patient is receiving anticoagulant therapy, then PT or PTT must be within therapeutic range of intended use of anticoagulants;

International normalized ratio (INR) or prothrombin time (PT) =<1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of treatment initiation

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Within 14 days prior to cycle 1 day 1 of treatment: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin Time (aPTT) =< 1.5 x ULN (Note: This applies only to subjects who are not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose)

Prothrombin time (PT) within 2 seconds of the upper limit of normal (institutional normal ratio [INR] =< 1.8)

International normalized ratio (INR)/prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.4 x ULN unless on therapeutic warfarin then INR/PT =< 3.5 obtained =< 14 days prior to registration

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 14 days of protocol registration

Prothrombin time (PT) < 1.5

Hepatic: Total bilirubin 1.5 x ULN; transaminases ? 2.5 x ULN (may be up to 5 x ULN if clearly due to liver metastases); prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x (ULN).

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to alternate assignment

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

Within 28 days prior to registration for protocol therapy: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy; in the case of anticoagulants, PT/INR/partial thromboplastin time (PTT) must be within therapeutic range of intended use of anticoagulants

Normal PT/INR and PTT;

A Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) within normal range

Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Determined within 3 weeks of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time/international normalized ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN)

FULL STUDY INCLUSION CRITERIA: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (Common Terminology Criteria for Adverse Events [CTCAE] grade =< 1)\r\n* Note: patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and partial thromboplastin time (PTT) / activated (a)PTT test results are compatible with the acceptable benefit-risk ratio at the investigator’s discretion

FULL STUDY INCLUSION CRITERIA: Partial thromboplastin time (PTT) or activated PTT (aPTT) =< 1.5 x ULN (CTCAE grade =< 1)\r\n* Note: patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator’s discretion

Prothrombin time (PT) =< 1.5 x ULN

Partial thromboplastin time (PTT) =< 1.5 x ULN

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULN

Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 ULN

Prothrombin time (PT) or international normalized ratio (INR) or partial thromboplastin time ?1.5 x ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 x ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to randomization.

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 14 days of registration

A prothrombin time (PT) or activated partial thromboplastin time (aPTT) above the ULN or a history of a coagulopathy or bleeding disorder.

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) levels ?1.5 x ULN. If institution does not report PT value, the international normalization ratio (INR) must be ? ULN.

Abnormal coagulation parameters (prothrombin time [PT] > 15 seconds, partial thromboplastin time [PTT] > 40 seconds, and/or international normalized ratio [INR] > 1.5)

International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) as follows: \r\n* In the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN\r\n* In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration

Obtained =< 14 days prior to registration: International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN

Prothrombin time (PT)/international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN

To be performed within 10 business days prior to day 1: If not receiving anticoagulants: international normalization ratio (INR) OR prothrombin (PT) =< 1.5 x ULN; if on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants

Within 14 days prior to planned start of treatment: If not receiving anticoagulants: international normalized ratio (INR) AND prothrombin (PT) =< 1.5 x ULN\r\n* If on anticoagulant therapy: PT must be within therapeutic range of intended used of anticoagulants

Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants

Acceptable coagulation status: international normalised ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ?1.5 x upper limit of normal (ULN).

Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 x ULN (unless B-ALL related)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin and partial thromboplastin times =< 1.2 x normal prior to biopsy

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulant (performed within 28 days of registration)

International Normalized Ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy, in which case, the PT/INR should be within therapeutic range for intended use, performed within 10 days of treatment initiation

International normalized ratio (INR) and/or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Normal prothrombin time (PT) or international normalized ratio (INR) and normal activated partial thromboplastin time (aPTT)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 10-15 days of treatment initiation)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 16 days of treatment initiation

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, during screening and on cycle 1, day 1

Contraindication to biopsy or prostatectomy (for neoadjuvant cohort only):\r\n* Bleeding disorders\r\n* Artificial heart valve\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 x ULN in patients not taking anticoagulation; patients on anticoagulation (e.g. enoxaparin, oral anticoagulants) are eligible regardless of PT/PTT; prior to biopsy, anticoagulation will be held per standard practice

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days of treatment initiation

Adequate hemostatic function as determined by prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 x ULN (unless on therapeutic coagulation, in which case the adequate level of anticoagulation will be determined by the investigator)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)

Obtained within 14 days prior to registration; prothrombin time and partial thromboplastin time (PT / PTT) ? 50% increase from institutional ULN

Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN

Prothrombin time (PT)/activated partial thromboplastin time (aPTT) within normal limits at time of surgery

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International Normalized Ratio (INR) or Prothrombin Time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Total bilirubin =< 1.5 X institutional limits; subjects with Gilbert's syndrome may have a bilirubin > 1.5 x upper limit of normal (ULN); activated partial thromboplastin time (aPTT), prothrombin time (PT) not to exceed 1.2 x ULN

International normalized ratio (INR) or prothrombin time (PT): =< 1.5 unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Completed within 10 days of SBRT treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =<1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control (within 14 days prior to registration)\r\n* NOTE: Abnormal PT/INR may be considered, with documented principal investigator (PI) approval, if it is due to the use of anticoagulants; for such patients, a normal PT/INR must be available from before the start of anticoagulation treatment\r\n* NOTE: Performed at time of screening angiogram; can be outside 14 days if applicable

If not receiving anticoagulants: international normalized ratio (INR) OR prothrombin (PT) =< 1.5 x ULN; if on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 14 days prior to registration

Within 14 days prior to registration: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) as follows:\r\n* In the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x upper normal limit (ULN) or aPTT < 1.5 x ULN\r\n* In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

UROTHELIAL CARCINOMA EXPANSION COHORT: Prothrombin (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within 1.25 X ULN institutional limits, except where a lupus anti-coagulant has been confirmed

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)

Prothrombin time (PT) < 1.5

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTT

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Partial thromboplastin time (PTT) < IULN

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) (activated PTT [aPTT]) < 1.5 x ULN

International normalized ratio (INR) =< 1.5 or prothrombin time (PT) =< 1.5 ULN, and a partial thromboplastin time (PTT/activated partial thromboplastin time [aPTT]) =< 1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; patients on anticoagulation are expected to hold anticoagulation for at least 5 days prior to surgery

Performed 28 days prior to study registration up to the first dose of study drug: international normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy; if subject receiving anticoagulants, PT or partial thromboplastin time (PTT) should be within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 28 days of treatment initiation)

International normalized ratio (INR) =< 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution

Performed within 14 days (+3 working days) of treatment initiation: Coagulation international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 X ULN

Normal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) ?1.3 ULN range acceptable).

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

No baseline prothrombin time (PT)/partial thromboplastin time (PTT) abnormalities, coagulopathies, or who are on any blood thinners

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 X IULN, AND international normalized ratio (INR) =< 1.5 X IULN (unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalization ratio (INR) < 1.5 x ULN

Partial thromboplastin time (PTT) < 1.5 x ULN

Partial thromboplastin time =< 1.5 x institutional ULN obtained within 14 days of first treatment

Prothrombin time (PT) =< 1.5 x ULN

Partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

PT and PTT <1.5 ULN

Prothrombin time (PT) =< 1.5 x institutional upper limit of normal (ULN)

Partial thromboplastin time (PTT) =< 1.5 x institutional ULN

Prothrombin time (PT) with an international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) of =< 1.5 times the ULN; for patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT < 1.2 times the ULN

Normal coagulation parameters (prothrombin time [PT], activated partial thromboplastin time [aPTT])

Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) (or activated partial thromboplastin time [aPTT]) > 1.5 x ULN

Performed within 28 days prior to study registration up to the first dose of study drug: International normalized ratio (INR) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or partial prothrombin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) < 14 sec; partial thromboplastin time (PTT) < 35 sec

International normalized ratio (INR) of prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 X ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

Prothrombin time (PT) and partial thromboplastin time (PTT) < 50% of deviation from institutional upper limit of normal (IULN)

Blood coagulation parameters: prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or anticoagulants for management of venous thrombosis including pulmonary thrombo-embolus) and a partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal

Failure to meet the following laboratory levels on preoperative screening:\r\n* Platelet count >= 100,000 mm^3\r\n* Hemoglobin >= 10 g/dl\r\n* Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)\r\n* Activated partial thromboplastin time =< 1.5 times ULN\r\n* Serum creatinine < 2.5 times ULN

Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

Normal prothrombin time (PT) for age

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

Prothrombin time (PT) no greater than 6 seconds longer than control.

Prothrombin time (PT)/international normalized ratio (INR)/ activated partial thromboplastin time (aPTT) =< 1.5 x ULN (to be performed within 7 days prior to start of study treatment)

Prothrombin time (PT) < 1.3 x upper limit of normal (ULN)

Partial thromboplastin time (PTT) < 1.3 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x institutional ULN

The subject has prothrombin time (PT)/International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

Prothrombin time (PT) with normal limits (WNL); if patient is on warfarin for prophylactic clot presentation for indwelling catheter, PT/partial thromboplastin time (PTT) may be +/- 15 %

Evidence of bleeding diathesis or coagulopathy as documented by an elevated prothrombin time (PT), partial thromboplastin time (PTT) or bleeding time

Partial thromboplastin time (PTT) < 70 seconds (sec)

Partial thromboplastin time (PTT) =< 1.2 x ULN

Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (secpatient may be eligible for trial if abnormality is deemed clinically insignificant and cleared for protocol therapy by Hematology Consult service)

Prothrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times control

Abnormal prothrombin time (PT) (international normalized ratio [Inr]) > 1.5 INR or partial thromboplastin time (PTT) > 42 seconds (sec) (may be corrected with flash frozen plasma [FFP], cryoprecipitate, vitamin K, etc)

Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3.

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x institutional ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional ULN

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.4 times upper limit of normal range

Prothrombin time (PT)/international normalized ratio (INR); partial thromboplastin time (PTT) =< 1.3; =< 1.3 x ULN

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN for age

Abnormal coagulation parameter (prothrombin time [PT] or activated partial thromboplastin time [aPTT] > 1.3x longer than standard reference)

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ? 1.5 x ULN (except for subjects receiving anticoagulation therapy)

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, should be performed within 10 days of treatment initiation

Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

PT and PTT ? 1.5 X ULN

Prothrombin time less than 1.5 × ULN for the institution

Laboratory values: Screening serum creatinine > upper limits of normal (ULN); total bilirubin > ULN: alanine aminotransferase (ALT) and AST >/= 2.5 ULN or >/= 5.0 x ULN if liver metastases are present; absolute neutrophil count < 1,500/mm3, platelet concentration < 100,00/mm3, hematocrit level < 27% for females or < 30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5 x ULN unless on therapeutic doses of warfarin.

Or partial thromboplastin time [PTT] > 100 sec

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapy

ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULN

HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULN

Prothrombin time (PT) and/or partial thromboplastin time (PTT) =< 1.5 X ULN.

Prothrombin time/partial thromboplastin time (PT/PTT) ? 1.5 x upper limit of normal (ULN) (unless receiving anticoagulation)

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International Normalized Ratio (INR) or prothrombin time (PT) ?1.5 × ULN (unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)

Prothrombin time (PT) =< 1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

For high risk and very high risk CLL-IPI (Arms A and B) only; obtained ? 30 days prior to randomization: prothrombin time (PT), international normalized ratio (INR), and partial thromboplastin time (PTT) ? 1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants

Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 x of institutional upper limit of normal (ULN) (Note: If coagulopathy is related to disease, this criteria do not apply) within 14 days prior to registration

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic range

PTT =< 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants within 7 days of treatment initiation

The subject has prothrombin time (PT)/institutional normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment

All screening labs should be performed within 14 days (+3 working days) of treatment initiation: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 x ULN.

INR (prothrombin time ratio) or partial thromboplastin time (PTT) > 1.5 x ULN (Please note: patients with hematopoietic cell transplantation (Hct) < 30%, WBC < 2500/mm/^3 and platelets < 50,000/mm^3 immediately prior to leukapheresis. The procedure may be deferred.)

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT of partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 28 days of treatment initiation

Prothrombin time (PT)/international normalized ratio (INR) less than or equal to 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) less than or equal to 1.5 x ULN

Within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) performed within 3 weeks prior to starting study therapy must be =< 1.5 x ULN

International normalized ratio (INR) within 1.5 times ULN (or if receiving anticoagulant therapy an INR of =< 3.0 is allowed with concomitant increase in prothrombin time (PT) or an activated partial thromboplastin time (aPTT) =< 2.5 x control)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anti-coagulant therapy as long as partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.2 times upper limit of normal

Prothrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x normal institutional standard

Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ? 1.6x unless therapeutically warranted

Partial thromboplastin time (PTT) within normal limits (+/- 15%)

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN =< 7 days before the first dose of study treatment

Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5

International normalized ratio (INR) or partial thromboplastin time (PTT)/prothrombin time (PT) =< 1.5 ULN, unless the patient is on stable therapeutic dose of warfarin

International normalized ratio (INR) or prothrombin time (PT): =< 1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio INR/ prothrombin time (PT)/ partial thromboplastin time (PTT) each < 1.5 x ULN

Patients with prothrombin time (PT) and/or international normalized ratio (INR) higher than or equal to 1.5 time upper limit of normal, unless patients have lupus anticoagulant in which case they are eligible if cleared by hematology

Partial thromboplastin time (PTT) =< 48 seconds (1.25 x ULN)

Activated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN)

International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, obtained =< 14 days prior to registration

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< upper limit of normal (ULN) for age

Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (11.6 - 15.2 / 25.3 - 37.3 sec)

Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 times the upper limit of normal

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy not requiring laboratory monitoring as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants; therapeutic Coumadin is not acceptable

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization

Prothrombin time (PT) > 12 seconds or partial thromboplastin time (PTT) > 31 seconds

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) must be < 1.5 x the upper limit of the normal range (ULN); except if, in the opinion of the investigator, the aPTT is elevated because of a positive lupus anticoagulant

International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants, specimens must be collected within 10 days prior to the start of study treatment

Prothrombin time (PT) within 2 seconds of the upper limit of normal (ULN)

Partial thromboplastin time (PTT) must be =< 1.5 × upper normal limit of institution's normal range

International Normalized Ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Partial thromboplastin time (PTT) =< 1.5 x ULN

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULN

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, international normalized ratio (INR) or platelet count (as determined by institutional lab parameters) at the time of screening

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.2 x upper limit of normal (ULN)

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

Prothrombin time (PT), international normalized ratio (INR) =< 1.5 x institutional ULN unless patient is therapeutically anticoagulated; if on anticoagulants, PT/INR need to be within appropriate anticoagulation limits for the clinical indication; patients who are receiving anticoagulants may participate in the trial if their anticoagulation can be stopped safely for several days at the time of each biopsy

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with PT/INR/PTT established within the therapeutic range prior to randomization; subjects will be eligible if it is determined by a hematologist that the cause is not associated with clinical bleeding (e.g., deficiency of factor XII), within 2 weeks of the first dose of study treatment

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization

For patients on Coumadin, INR/prothrombin time (PT)/PTT must be > 1.5 ULN

Prothrombin time (PT) =< 1.2 x ULN

Prothrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the institutional upper limit of normal

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal (IULN) (subjects on Coumadin are included if their coagulation is within a normal therapeutic range)

Partial thromboplastin time (PTT) < 1.5 x the upper limit of institution’s normal range

Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal within 10 days prior to registration unless the patient is receiving coumadin and has a stable INR that is in range for the desired level of anticoagulation

Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 x ULN

Prothrombin time (PT)/international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control; if subjects are being anticoagulated they can participate if proof of no coagulation abnormality existed prior to use of anticoagulants

PT ?1.5 ULN

Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.2 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.2 x ULN; Note: Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation

Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN

Normal coagulation [prothrombin time and partial thromboplastin time within normal limits (±15%)].

Partial thromboplastin time (PTT) =< 1.2 x IULN (if not receiving anticoagulation therapy)

Prothrombin time (PT) or partial thromboplastin time (PTT) test >= 1.3 x laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatment

Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 X ULN after correction of nutritional deficiencies that may have contributed to prolonged PT/PTT.

Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)

Prothrombin time (PT) and activated partial thromboplastin time (APTT) =< 1.5 times upper limit of normal

INR ? 2.3 or Prothrombin time (PT) ? 6 seconds above control;

International normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)

Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN.

Prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)

PT <1.5 ULN

Baseline laboratory data as defined as: Hemoglobin (Hb): >=8g/dL Absolute Neutrophil Count (ANC): >=1000/µL Platelet (PLT): >=25000/µL Glomerular Filtration Rate (GFR) or Creatinine Clearance: >=30ml/min Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): <3 x Upper Limit of Normal (ULN) Bilirubin - total: <1.5 x ULN Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) or International Normalized Ratio (INR): <=1.5 x ULN PT <=1.5 x ULN, INR <=1.5

AMKL PATIENTS: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN

MF PATIENTS: PT and PTT =< 1.5 x ULN

Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN

Coagulation parameters: international normalized ratio (INR) =< 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 X institutional ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Coagulation: Prothrombin time (PT) <1.5 × ULN and partial thromboplastin time (PTT) <1.5 × ULN

Normal prothrombin time (PT)/international normalized ratio (INR) and partial prothrombin time (PTT)

Prothrombin Time or INR ?1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation.

Partial Thromboplastin Time (PTT) ?1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation.

Evidence of bleeding diathesis, coagulopathy as documented by an elevated (? 1.5 x ULN) prothrombin time (PT), partial thromboplastin time (PTT), or bleeding time. The use of full-dose oral or parenteral anticoagulants is permitted as long as the PT or aPTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the subject has been on a stable dose of anticoagulants for at least 2 weeks prior to the first study treatment.

INR and PTT within 1.5 X institutional ULN

Acceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (+/-15%).

Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN

International normalized ratio (INR)/prothrombin time (PT) =< 1.5 X ULN (unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time [PTT] is within therapeutic range of intended use of anticoagulants)

International normalization ratio (INR) or prothrombin time (PT) 1.5 x upper limit of normal (ULN), unless the subject is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) or prolongation of the activated thromboplastin time (aPTT) >1.5 ULN or active uncontrolled coagulopathy or bleeding disorder.

Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULN

PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional upper limit of normal (ULN)

Prothrombin time (PT) =< 1.5 times the upper limit of normal

Partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal

Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 and a partial thromboplastin time (PTT) =< 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parameters

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal

Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 x ULN

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN for the lab

Partial thromboplastin time > 50 seconds (secs)

Prothrombin time (PT) within normal limits (UIHC)

Adequate coagulation defined as:\r\n* Prothrombin time (PT) =< 1.2 x upper limit of normal

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatment

Partial thromboplastin time (PTT) =< 1.2 x institutional ULN

Prothrombin time (PT) < 1.2 x ULN

Patients must NOT have a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) (greater than 1.2 times the institutional upper limit of normal)

Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/ international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normal

The following laboratory values obtained =< 14 days prior to randomization\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 X ULN if not anticoagulated; within local institutional guidelines per local physician if anticoagulated

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (within 14 days of treatment initiation)

Prothrombin time/international normalized ratio (INR) and partial thromboplastin time within normal limits

Prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN

Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x institutional upper limit of normal, within 14 days of study registration

Within 72 h of initiating study treatment: International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x ULN unless on anticoagulation medication with stable dosing for at least one month; in addition, patient must be able to stop taking medication for up to a week in order to have percutaneous biopsies of tumor tissue performed

No patients will have coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% deviation of the institutional ULN

Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on warfarin therapy, levels should be within therapeutic range

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 x ULN unless participant is receiving anticoagulant therapy as long as prothrombin time (PT) or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Other: Prothrombin time (PT) and partial thromboplastin time (PTT) < ULN.

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN

International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) as follows: in the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN; in the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration (within 7 days prior to registration)

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN)

Within 4 weeks of administration of study therapy: International normalized ration (INR) or prothrombin time (PT) =< 1.5 x ULN (only if not using anticoagulants); if patient is receiving anticoagulants, then value must be within therapeutic range for the condition that patient is being treated for

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULN

Partial thromboplastin time 5 seconds above ULN.

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, performed within 14 days prior to registration

Within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Partial thromboplastin time (PTT) less than or equal to 1.3 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (only if submitting to a biopsy), performed within 28 days of treatment initiation

Normal prothrombin time (PT)/partial thromboplastin time (PTT)

International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; if on active anticoagulants prior to study treatment, levels must be within standard therapeutic ranges per investigator

International normalized ratio (INR) < 2, prothrombin time (PT) < 20 sec, and partial thromboplastin time (PTT) < 55 sec

Partial thromboplastin time (PTT) < 1.5 times upper limit of normal within 14 days before enrollment

Adequate coagulation parameters, defined as International Normalisation Ratio <1.5 x ULN or activated partial thromboplastin time <1.5 x ULN.

Partial thromboplastin time (PTT) =< 1.5 times the upper limit of normal

prothrombin time (PT) and activated partial thromboplastin time (PTT) ? 1.6 x control unless therapeutically warranted

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 X ULN; if value is higher due to hepatic involvement by CLL, patient is eligible

At least 4 weeks (28 days) prior to registration: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless on medication known to alter INR and aPTT)

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the institutional ULN =< 7 days before the first dose of study treatment, unless PT/PTT prolongation known to be secondary to conditions not associated with increased bleeding risk (as on antiphospholipid antibody syndrome)

pT3, G any, N1; or, pT4, G any, N1; or, pT any, G any, N1 or M1)

Prothrombin time (PT) and partial thromboplastin time (PTT) must not be more than 1.5 x upper limit of normal (ULN) within 72 hours prior to enrollment; PT and PTT should be drawn by venipuncture, rather than from a central venous catheter when feasible

International normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) > 1.5 × ULN (unless on anticoagulation medication)

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal (ULN)

Partial thromboplastin time (PTT) =< 60

Prothrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (aPTT) =< 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization\r\n* NOTE: this applies to patient in the normal and renal dysfunction cohorts (N, R3 and R4); elevated PT/INR is allowed for patients in the liver dysfunction cohorts

Prothrombin time (PT)-international normalized ratio (INR) =< 2.3 or PT =< 6 seconds above control

Coagulopathy (as evidence by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times upper limit of normal in patients not undergoing anticoagulation)

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) < 1.5 x ULN

Prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapy

Partial thromboplastin time (PTT) =< 1.5 X institutional upper limit of normal

Partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)

Partial thromboplastin time (PTT) >= 45 seconds

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limits of normal

Prothrombin time (PT) and partial thromboplastin time =< 1.5 upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulation

Absence of active treatment with systemic anticoagulation and a baseline prothrombin time (PT) and activated partial thromboplastin time (aPTT) that does not exceed 1.5 x ULN

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (Note: subjects receiving anticoagulation treatment may enroll with INR established within the therapeutic range prior to day 1 [D1] of treatment)

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatment

Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.2 x institution’s ULN

Subjects must have normal coagulation parameters as measured by prothrombin time (PT)/partial thromboplastin time (PTT)

Prothrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (APTT) =< 1.5 x upper limit of normal (ULN), unless the abnormality can be explained by the presence of lupus anticoagulant or if these values are in the therapeutic range for a patient on low molecular weight heparin

Prothrombin time (PT)/INR and partial thromboplastin time (PTT) =< grade 1 within two weeks before initial biopsy of visceral organs

Prothrombin time (PT) =< 1.2 X ULN; subjects receiving anticoagulant therapy are eligible if their PT is stable and within the recommended range for the desired level of anticoagulation

Partial thromboplastin time (PTT) =< 1.2 ULN; subjects receiving anticoagulant therapy are eligible if their PTT is stable and within the recommended range for the desired level of anticoagulation

The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 X the laboratory ULN

Partial thromboplastin time (PTT) must be =< 1.5 × upper normal limit of institution's normal range

The patient has a PT (or INR) and PTT up to 1.25×ULN

Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis) and a partial thromboplastin time (PTT) < 1.2 x ULN

Partial thromboplastin time (PTT) < 1.2 times institutional upper limit of normal

Prothrombin and partial thromboplastin times =< 1.2 x normal prior to biopsy

Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 X the ULN unless a subject is receiving Coumadin and has stable INR which is in range for the desired level of anticoagulation

For patients undergoing biopsy procedures: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be within the normal range

Prothrombin time (PT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy

Partial thromboplastin time (PTT) =< 2 x normal outside the setting of stable chronic anticoagulation therapy

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.2 X upper limit normal (ULN)

Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphoma

International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) less than or equal to 1.5 x ULN, unless patient is receiving anticoagulant therapy as long as PT or INR is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

The patient has an adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) or prothrombin time (PT) =< 1.5 x ULN, and partial thromboplastin time (PTT or aPTT) =< 1.5 x ULN (those receiving anticoagulation therapy except low molecular weight heparin are excluded) within 30 days prior to registration

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalize ratio (INR) and the partial thromboplastin time (PTT) < 1.5 x ULN. (Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists)

Prothrombin time (PT)/international normalized ratio (INR) > 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) > 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)

Partial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulation

Prothrombin time or INR =< 1.5 x ULN unless receiving therapeutic anticoagulation

Partial thromboplastin time (PTT) =< 1.2 x upper limit of normal (ULN) unless the patient is receiving therapeutic anticoagulation

Prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapy

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 120% of control, unless patient has the presence of a lupus anticoagulant

active, uncorrected bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, or INR at the time of HIFU (use international lab normal ranges for parameters);

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR), activated partial thromboplastin time (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT), partial thromboplastin time (PTT) less than or equal to 1 to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1 except for patients on therapeutic anticoagulation

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x upper limit of normal (ULN) unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Patients must have baseline prothrombin time (PT)/international normalized ratio (INR) < 3 x institutional upper limit of normal and partial thromboplastin time (PTT) < 3 x ULN within 7 days of initiating the induction cycle; (for patients with coagulation abnormalities that are correctable, coagulation factor support per institutional standard of care for AML is allowed)

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <1.5 times the upper limit of normal (ULN)

Prothrombin time and activated partial thromboplastin time (aPTT) < 1.5 times the upper limit of normal (ULN)

Subjects must have adequate coagulation as assessed by: international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN (CTCAE Grade <=1), partial thromboplastin time (PTT) <=1.5 x ULN (CTCAE Grade <=1)

Coagulopathy (as evidenced by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times in control patients not undergoing anticoagulation)

International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN

Prothrombin time (PT-INR)/ partial thromboplastin time (PTT) ? 1.5 x ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement that is pre dose as defined by the local standard of care

Subject has acceptable coagulation studies (obtained ? 14 days prior to starting Cycle 1 Day 1) partial thromboplastin time (PTT) < 1.2 x ULN and INR ? 1.5 x ULN.

Normal partial thromboplastin time (PTT) and either international normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN

Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)

The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 the laboratory ULN within 7 days before the first dose of study treatment

Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X ULN

Partial thromboplastin time (PTT) < 1.2 x institutional upper limits of normal

International normalized ratio of prothrombin time and activated partial thromboplastic time </=1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.

Prothrombin time (PT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic range, or

Prothrombin time < 1.5 x ULN

Prothrombin time (PT) or International Normalized Ratio (INR) ? 1.25 x ULN; for patients with hepatocellular carcinoma only, INR <1.7 or prothrombin time (PT) or < 4 seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulation parameter); for patients with hepatocellular carcinoma only, serum albumin > 2.8 g/dL (i.e. Child-Pugh Score for albumin is no greater than 2). For the hematologic malignancy patients, the coagulation and albumin status cited above do not apply

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN

Normal prothrombin time

International normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate

Prothrombin time (PT) ? 1.5 x ULN

TREATMENT: Prothrombin time (PT) within 2 seconds of the upper limit of normal (ULN)

TPI 287 may interfere with Coumadin dosing and patients who are taking this combination will require monitoring of their prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR)

Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 times the institutional upper limit of normal; patients receiving low molecular weight heparin for the prevention or treatment of venous thromboembolic disease are eligible if considered clinically stable on their regimen

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants within 7 days of treatment initiation

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 upper limit of normal (ULN)

Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless subject is receiving anticoagulants; if the subject is on anticoagulation therapy, levels should be within therapeutic range

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.5 x the laboratory ULN within 7 days before the first dose of study treatment

The subject has prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test results at screening >= 1.5 x the laboratory upper limit of normal

Serum creatinine >ULN, or Prothrombin time (PT) or international normalized ratio (INR) >1.5 × ULN or activated partial thromboplastin time (aPTT) > 1.5 × ULN

International normalized ratio or prothrombin time (PT) ? 1.5 x ULN unless subject is receiving anticoagulant therapy and the PT or partial thromboplastin time (PTT) must be within the therapeutic range of the intended use of anticoagulants.

Prothrombin time (PT)-international normalized ratio (INR)/partial thromboplastin time (PTT) < 1.5 x ULN except in patients receiving active anticoagulation

Coagulation status: prothrombin time (PT) ? 1.5 ULN or INR within normal limits; and partial thromboplastin time (PTT) ? 1.2 × ULN

No evidence of coagulopathy as indicated by prothrombin time (PT) =< 1.5 X upper limit of normal

Normal PT or INR and aPTT

PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN

Performed within 10 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy in which case the INR or PT must be within the therapeutic range of intended use for the anticoagulant

Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN

Patients with known bleeding diathesis, or PT (Prothrombin time) or aPTT (activated partial thromboplastin time) > 1.5x ULN or <0.5x LLN.

Prothrombin time (PT) and activated partial thromboplastin time (aPTT) <=1.5*ULN

Patients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal

PT/aPIT ? 1.5 x ULN

Prothrombin time (PT)/International normalized ratio (INR) and partial thromboplastin time (PTT) <=1.3xULN

Coagulation parameters: International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN

The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening that are >= 1.3 x ULN

PART I: Absolute neutrophil count (ANC), hemoglobin, platelet, total bilirubin, creatinine, transaminase (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]), prothrombin time (PT), partial thromboplastin time (PTT), urine uric acid, urine pH, urine oxalate must be within standard normal ranges

PT/INR and aPTT ? 1.5 ULN.

Adequate baseline organ function as defined by: absolute neutrophil count (ANC) >= 1.2 × 109/L; Hemoglobin >= 9 g/dL; Platelet count >= 100 x 109/L; prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) <= 1.5 x upper limit of normal (ULN); Albumin >= 2.5 g/dL; Total bilirubin <= 1.5 x ULN; aspartate aminotransferase (AST) and alanine transaminase (ALT) <= 2.0 x ULN; Creatinine <=1.5 mg/mL; Left Ventricular Ejection fraction (LVEF) >= lower limit of normal (LLN) by ECHO

Partial thromboplastin time (PTT) > 80

Prothrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)

Prothrombin time (PT) and partial thromboplastin time (PTT) ? 1.2 x the upper limit of normal (ULN) unless receiving anticoagulation therapy. If receiving anticoagulation therapy, eligibility will be based upon International Normalization Ratio (INR)

Coagulation Prothrombin time ? 1.5 X upper limit

Partial thromboplastin time ? 1.5 X upper limit

International normalized ratio (INR) or prothrombin time (PT) ? 1.5 × ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Partial thromboplastin time (PTT) or activated (a)PTT =< 1.5 x upper limit of normal (ULN) per institutional laboratory range

Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)

International normalized ratio (INR) < 1.5 and a partial thromboplastin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly (INR must be therapeutic in the range of 2-3)

Prothrombin time (PT) =< 4 seconds above upper limit of normal (ULN) and partial thromboplastin time (PTT) =< 10 seconds above ULN

Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution

Partial thromboplastin time (PTT) < 1.2 times the upper limit of normal

Prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 x the upper limit of normal, except if the patient is on therapeutic anticoagulation, in which case they should demonstrate stability of PT/PTT for at least two weeks

Partial thromboplastin time (PTT) =< 1.2 X ULN

Prothrombin time (PT) < 1.5 ULN

Prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN

Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x IULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)

Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)

Prothrombin time (PT) such that the international normalized ratio (INR) is less than or equal to 1.2 x ULN (institutional upper limit of normal) (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and PT/PTT therapeutic and within the recommended range for the desired level of anticoagulation

Prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.2 X upper limit of normal (ULN)

International normalized ratio (INR) of prothrombin time (PT; PT-INR) and activated partial thromboplastin time (aPTT) =< 1.5: subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists per medical history; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care

Partial thromboplastin time (PTT) within normal limits (WNL)

Prothrombin time > 1.5 x control

Have a bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140,000 platelets per microliter of circulating blood1

Prothrombin time (PT) and partial thromboplastin time (PTT) > 1.5 x ULN

Prothrombin time (PT) and partial thromboplastin (PTT) =< 1.5 x IULN

International normalized ratio (INR)/prothrombin time (PT) =< 1.5 times ULN unless participant is receiving anticoagulant therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

Patients must have prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) =< 2.0 x institutional upper limit of normal (IULN) unless the patient is on anticoagulant therapy within 28 days prior to registration (if the patient is receiving anticoagulant therapy, PT, and a PTT must be within therapeutic range of intended use of anticoagulants)

Partial thromboplastin time (PTT) =< 60

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (performed within 10 days of treatment initiation)

Partial thromboplastin time (PTT) < 1.5 times the upper limit of normal (heparin, lovenox or alternative anticoagulants are acceptable)

Evidence of bleeding diathesis or coagulopathy (partial thromboplastin time [PTT] and/or either prothrombin time [PT] or international normalized ratio [INR] > 1.5 x upper limit of normal) (except for subjects receiving anti-coagulation therapy); concurrent use of Coumadin or warfarin will be acceptable and monitoring patients on warfarin or Coumadin will follow the standard of care as dictated by the prescribing physician (PT/PTT); if the prescribing physician is not a Moffitt medical doctor (MD), then the prescribing MD will be notified by the research staff of the subject participating in the study, and monitors for PT, PTT will be obtained from patient during the 3 month study visit for review

Prothrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normal (ULN) for age

Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN

International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time [PTT] is within therapeutic range of intended use of anticoagulants)

Subjects unable to undergo routine endoscopy with biopsy:\r\n* Women who are pregnant or breastfeeding\r\n* Prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 2.0\r\n* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issues

Prothrombin time greater than 50% of control

Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal

Screening laboratory values (serum chemistry, hematology, prothrombin time [PT](international normalized ratio [INR])/activated partial thromboplastin time [APTT], and creatine phosphokinase [CPK]) obtained up to 28 days prior to administration of first vaccine injection on day 0 within institutional normal range or judged to be not clinically significant by principal investigator (PI) and medical monitor

Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limits

Presence of coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.2 x upper limit of normal)

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 x upper limit of normal

Thrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) > 2 x upper limit of normal

Prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. For participants who have taken an anticoagulation within the past 7 days, international normalized ratio must be ? 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ? ULN prior to the breast biopsy.

Patients not taking warfarin must have prothrombin time (PT)/partial thromboplastin time (PTT) levels =< 1.5 times the upper limit of normal provided by the reference laboratory performing the test

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times institutional upper limit of normal

Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN; unless the patient is on a therapeutic anticoagulant

Prothrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limits

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Partial thromboplastin time (PTT) =< 2 x upper limit of normal (ULN)

PTT (partial thromboplastin time) =< 1 x ULN

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN, unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, obtained within 14 days prior to C11-AMT PET scan

PT/PTT/INR (prothrombin time/partial thromboplastin time) without clinically significant abnormalities after review by the study physicians

Contraindication to biopsy:\r\n* Bleeding disorders\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 times the upper limit of normal\r\n* Artificial heart valve

Patients with coagulopathies who are at increased risk for bleeding or on active anti-coagulation therapy (platelets less than 100,000 per mm^3 or prothrombin time [PT]/partial thromboplastin time [PTT] greater than 1.5 times the upper normal limit [UNL]); patients are eligible if the underlying cause is correctable

Partial thromboplastin time less than 4.0 times below or above the upper or lower limit range

Partial thromboplastin time (PTT) =< 1.2 X ULN (evaluated within 28 days of randomization)

Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional upper limit of normal (within 14 days of study registration)

Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 x upper limit of normal (ULN), completed within 2 weeks prior to start of protocol therapy

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, obtained =< 30 days prior to registration

International normalized ratio (INR) OR prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of treatment initiation

Pre-treatment laboratory tests for patients receiving fluorine F 18 fluorothymidine ([18F]FLT) must be performed within 21 days prior to baseline imaging; these laboratory tests must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless not clinically relevant); 2.5 x for prothrombin time and partial thromboplastin time; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range; the initial 4.0 x value will be critical for liver function test results which can be extremely variable, and a 4.0 x above the upper normal range is still acceptable for inclusion in this study; urinalysis abnormalities will not preclude the patient from being enrolled and studied; the baseline and subsequent laboratory testing will include liver enzymes (serum glutamic oxaloacetic transaminase [SGOT], serum glutamate pyruvate transaminase [SGPT], anaplastic lymphoma kinase [ALK]), bilirubin (total), serum electrolytes, complete blood count (CBC) with platelets prothrombin time, partial thromboplastin time, blood urea nitrogen (BUN), and creatinine

Prothrombin time (PT)/partial thromboplastin time (PTT) =< the institution ULN

PT/PTT > the institution ULN

Prothrombin time > 1.5 x control

Patients with abnormal prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) or bleeding diathesis

Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 X upper limit of normal (ULN)

Coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.5 x upper limit of normal)

internal normalized ratio and partial thromboplastin time <1.5x upper limit of normal

The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits.

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International Normalized Ratio (INR) or Prothrombin Time (PT) ? 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, performed within 10 days of protocol enrollment

Prothrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normal

International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants