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Dose escalation schema and dose limiting toxicity
| Dose Level | Dose Limiting Toxicity | |
|---|---|---|
| n DLT/N DL | CTCAE v4.03 Term (Grade) | |
| Dose Level 1 = 225 mg/kg | 0/3 | No DLT |
| Dose Level 2 = 300 mg/kg | 1/6 | Allergy (3) |
| Interim Dose level 2.5 = 375 mg/kg | Not required | |
| Dose Level 3 = 450 mg/kg | 1/6 | Infusion Related Reaction (2) (precluding completion of NAC) |
DLT = dose limiting toxicity; DL = dose level. CTCAE = Common Terminology Criteria for Adverse Events (CTCAE) v4.03; NAC = N-acetylcysteine
