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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective review of nine patients diagnosed with leukaemia or lymphoma, four patients (two girls and two boys) aged 10−13 years were described, who experienced methotrexate-induced stroke like neurotoxicity in the form of leukoencephalopathy, which was further potentiated by cyclophosphamide, cytarabine, mercaptopurine and prednisolone [not all routes stated; dosages not stated].
Patient 1: An 11-year-old boy diagnosed with B-cell precursor acute lymphoblastic leukaemia started receiving chemotherapy comprising intrathecal methotrexate in the induction phase, two doses of cyclophosphamide over 4 weeks, four blocks of cytarabine, oral mercaptopurine [6-mercaptopurine], prednisolone and two doses of intrathecal methotrexate during the early intensification phase. However,...