A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

Complete Remission (CR)

Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Complete Remission With Incomplete Platelet Count Recovery (CRp)

Normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Partial Remission (PR)

Normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Hematological Improvement

HI with duration (HI) 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Stable Disease (SD)

Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.

Time frame: up to 43 months

Blood Products Transfused

Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation.

Time frame: up to 43 months

Hospitalized Days

In-patient days in hospital.

Time frame: up to 12 months

1-year Survival

One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization.

Time frame: Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage).

Duration of Complete Remission (dCR)

Durations of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to \<=5 % blasts; independent of transfusions\*; and no extramedullary leukemia. \* independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)

Duration of normalization of bone marrow to \<=5% blasts; peripheral neutrophils \>=1000 /microliter, platelet \<=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions\*; and no extramedullary leukemia. \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Duration of Partial Remission (dPR)

Duration of normalization of peripheral neutrophils to \>=1000 /microliter, platelet to \>=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, \>=50% decrease in bone marrow blasts over pre-treatment but still \>5%; independent of transfusions\* \*independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Duration of Hematological Improvement (dHI)

Duration of HI 1. Erythroid response (HI-E) for patients with pre-treatment hemoglobin \< 11 g/dL; Major response: \>2 g/dL increase in hemoglobin; for RBC, transfusion independence\* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements 2. Platelet response (HI-P) for pre-treatment platelet count \<100,000/mm3; Major response: an absolute increase of platelet count by \>=30,000/mm3; stabilization of platelet counts and platelet transfusion independence\* Minor response: \>=50% increase in platelet count with a net increase \> 10,000/mm3 but \<30,000/mm3 3. Neutrophil response (HI-N) for absolute neutrophil count (ANC) \< 1,500/mm3 before therapy; Major response: \>=100% increase, or an absolute increase of \>500/mm3, whichever is greater Minor response: \>=100% increase, but absolute increase \< 500/mm3 * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response

Time frame: up to 43 months

Duration of Stable Disease (dSD)

Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for \> 16 weeks.

Time frame: up to 43 months