Assessments
PD, AML, death, Cancer
ADVERSE EVENT, ADVERSE EVENT, AML, CANCER
Safety evaluations were performed in enrolled patients throughout the study, including adverse event (AE) monitoring, physical examination, vital sign measurement, variables in electrocardiogram/two-dimensional echocardiogram/multi-gated acquisition scans and clinical laboratory testing (hematology, chemistry, liver functions and urinalysis) as measures of safety and tolerability for the entire study duration.Treatment-emergent AEs (TEAEs) were defined as those that occurred between the first dose of the study drug until 30 days after the last dose of the study drug. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03.Disease assessments were conducted at the discretion of the investigator according to patients’ physical findings, peripheral blood counts and/or bone marrow assessment during the study treatment, mainly at screening, the end of Cycle 1 and every three cycles thereafter. Clinical responses were defined according to the modified International Working Group Criteria for AML (Transfusion independence was defined as a period of at least 56 consecutive days with no red blood cell or platelet transfusion during the evaluation period. The post-baseline transfusion evaluation period was from the first dose of the study drug to the last dose of the study drug plus 30 days, PD, confirmed morphological relapse or death, whichever occurred earlier.