Table 5

Laboratory abnormalities in clinical trials

CML-BC (n = 260) 600 mg n = 223 400 mg n = 37 (%)CML-AP (n = 235) 600 mg n = 158 400 mg n = 77 (%)CML-CP, IFN failure (n = 532) 400 mg (%)
Grade 3Grade 4Grade 3Grade 4Grade 3Grade 4
Hematology parametersa
 Neutropenia16462434258
 Thrombocytompenia2731301216<1
 Anemia40103154<1
Biochemistry parametersa
 Elevated creatinine1.201.3000
 Elevated bilirubin3.501.700.40
 Elevated alkaline phosphatase4.605.10.40.20
 Elevated SGOT (AST)1.002.101.10
 Elevated SGPT (ALT)2.30.43.001.70
  • a Common Toxicity Criteria grades. Neutropenia: grade 3, >0.5–1.0 × 109/liter; grade 4, <0.5 × 109/liter). Thrombocytopenia: grade 3, ≥10–50 × 109/liter; grade 4, <10 × 109/liter. Anemia: hemoglobin, ≥65–80 g/liter; grade 4, <65 g/liter. Elevated creatinine: grade 3, >3–6 times the upper limit normal range (ULN); grade 4, >6 times the ULN). Elevated bilirubin: grade 3, >3–10 times the ULN; grade 4, >10 times the ULN. Elevated alkaline phosphatase: grade 3, >5–20 times the ULN; grade 4, >20 times the ULN. Elevated SGOT or SGPT: grade 3, >5–20 times the ULN; grade 4, >20 times the ULN.