- Subjects with any of the following laboratory values Hemoglobin < 10.0 g/dL WBC < 3500/mm3 (< 3 x 109/L) Platelets < 120,000/mm3 (< 3 x 109/L) Serum creatinine > 2 times the ULN Serum ALT or AST > 2 times the ULN