PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
Coagulation: PT > 4 seconds more than ULN or INR > 1.7
PTT =< 1.3 x ULN
PTT > 1.3 x ULN
INR > 1.3
Abnormal coagulation profile (PT or INR, PTT) > 1.3x ULN
PT/INR ? ULN within 28 days of randomization. Patients receiving therapeutic anti-coagulants are not eligible.
INR < 1.5 × ULN
PT and PTT <1.5 x ULN
PT and PTT w/in ?1.5× ULN
INR ?1.5× ULN
PHASE IB: PT (or INR) and PTT =< 1.5 x ULN
PART II: PT/PTT =< 1.5 x the upper limits of normal
PTT & INR within institutional limits.
PT-INR > 2x upper limit of normal reference range (ULN) in the absence of anticoagulation within 7 days prior to Day 1
INR ? 1.5
INR < 1.5 × ULN
Patients on a stable dose of anti-coagulation therapy will be allowed to participate if they have no signs of bleeding or clotting and the INR/PT and PTT/aPTT results are compatible with an acceptable risk-benefit ratio as per the investigator’s discretion
INR ? 1.5 x ULN;
Normal PT/INR and PTT;
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
INR ?1.5
INR > 2
Acceptable coagulation status: INR ?2.0 x ULN and PTT ?2.0 x ULN.
INR >= 2
PT and PTT <1.5 ULN
INR and APTT ? 1.5 x ULN.
Patients must have INR and PTT values ? 1.5X ULN for the reference laboratory.
PTT WNL; if patient on warfarin for prophylactic clot presentation for indwelling catheter, PT/PTT may be +/- 15 %
Abnormal level of platelets (< 100000), PT (>14) or PTT (>36), and INR > 1.3.
PT and PTT ? 1.5 X ULN
Patients with PT/PTT above the upper limit of normal
PTT =< 1.5 x ULN unless on anticoagulation therapy, in which case PT or PTT should be in the therapeutic range
INR > 2.5
INR =< 1.5
For patients on Coumadin, INR/prothrombin time (PT)/PTT must be > 1.5 ULN
PT ?1.5 ULN
PTT ?1.5 ULN
INR < 1.5 or PTT value < 1.5 x upper limit of normal (ULN) at study entry
Bleeding disorder (INR > ULN and PTT > ULN)
PT <1.5 ULN
PTT <1.5 ULN
MF PATIENTS: PT and PTT =< 1.5 x ULN
PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.
INR and PTT within 1.5 X institutional ULN
INR < 2.0
PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
PT/INR, PTT, and fibrinogen within institutional acceptable limits
For patients not taking warfarin: INR ?1.5 or PT ?1.5 × ULN; and either PTT or aPTT ?1.5 × ULN. Patients taking warfarin should be on a stable dose that results in a stable INR <3.5.
INR < 1.5 × ULN
pT3, G any, N1; or, pT4, G any, N1; or, pT any, G any, N1 or M1)
INR and aPTT < 1.5 X ULN unless on medication known to alter INR and aPTT.
Screen labs of Hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, AST, ALT, serum creatinine, serum albumin, PT/INR, and PTT within specified values/criteria per protocol prior to dosing.
The patient has a PT (or INR) and PTT up to 1.25×ULN
INR < 1.5 × ULN
INR and aPTT within 1.5 ULN
PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN (When treated with warfarin or other vitamin K antagonists, then INR ?3.0).
INR > 1.5
Normal PT or INR and aPTT
PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN
PT/aPIT ? 1.5 x ULN
INR ? 1,5
PT/INR and aPTT ? 1.5 ULN.
Patients with pT3 or pT4 disease
PT/PTT > the institution ULN