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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 of 44 paediatric patients, two boys and two girls aged 10−14 years old were described, who developed secondary chemo-resistance to mitoxantrone, cytarabine and etoposide during treatment for acute myeloid leukaemia (AML) [dosages and routes not stated].
Patient 1: The 10-year-old girl was diagnosed with AML. She showed lack of mutations in the dominant clone. Induction chemotherapy with mitoxantrone, cytarabine and etoposide was administered and a complete response was noted. Six months later, a relapse was noted. Therefore, she received induction chemotherapy with mitoxantrone, cytarabine and etoposide, following which a partial response was noted. The bone marrow (BM) blasts % by morphology, which was 83.50 at baseline and 0.45 after the first induction chemotherapy...