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Table 1 Definition of dose-limiting toxicity

From: Selective TACE with irinotecan-loaded 40 μm microspheres and FOLFIRI for colorectal liver metastases: phase I dose escalation pharmacokinetic study

Definition of dose-limiting toxicity
• Grade 4 neutropenia or thrombocytopenia
• Grade 3 or 4 neutropenia plus fever higher than 38.0 °C
• Grade 4 aspartate transaminase and/or alanine transaminase elevation were held over 1 week
• Serum total bilirubin was 5 mg/dl or 3 mg/dl was held over 2 weeks
• Liver abscess, cholangitis and cholecystitis required drainage and surgical resection
• Non-hematologic toxicities of grade 3 or more (excluding that from disease progression, fatigue, fever, nausea, vomiting, pain and alopecia)