Table 1.
System | Laboratory value |
---|---|
Hematological | |
Absolute neutrophil count | ≥1500/mcL |
Platelets | ≥100,000/mcL |
Hemoglobin | ≥9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment) |
Renal | |
Serum creatinine OR
Measured or calculateda creatinine clearance |
≤1.5 X upper limit of normal (ULN) OR
≥60 mL/min for subject with creatinine levels >1.5 X institutional ULN |
Hepatic | |
Serum total bilirubin | ≤1.5 X ULN OR |
Direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 ULN | |
AST (SGOT) and ALT (SGPT) | ≤2.5 X ULN OR
≤5 X ULN for subjects with liver metastases |
Albumin | ≥25 g/L |
Coagulation | |
International normalized ratio (INR) or prothrombin time (PT) Activated partial thromboplastin time (aPTT) |
≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants |
aCreatinine clearance should be calculated per institutional standard