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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 study, 4 boys and 2 girls aged 4−14 years were described who developed posterior reversible leukoencephalopathy syndrome (PRES) or tumour lysis syndrome (TLS) during treatment with amikacin, antithymocyte globulin, asparaginase, cefepime, ciclosporin, cytarabine, cyclophosphamide, daunorubicin, dexamethasone, etoposide, idarubicin, ifosfamide, imipenem, meropenem, methotrexate, metronidazole, prednisolone, vincristine or voriconazole [not all routes, dosages, duration of treatments to reactions onset and outcomes stated].
Patient 1: A 5-year-old boy had been diagnosed with T-cell acute lymphoblastic leukaemia (ALL) and started receiving ALL-BFM 90 chemotherapy protocol comprising prednisolone, vincristine and methotrexate at a local center. He had been receiving low-dose...