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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 62-year-old woman experienced clonal evolution of Philadelphia chromosome during treatment with cytarabine, cladribine, unspecified granulocyte colony stimulating factors and azacitidine for acute myeloid leukaemia [AML; not all routes and dosages stated].
The woman presented with significant joint pain and myalgia over a period of 5 months. Laboratory tests were consistent with a diagnosis of AML. Cytogenetic testing showed a normal female karyotype with normal FISH for AML/myelodysplastic syndrome. Flow cytometry revealed 27% aberrant myeloblasts expressing CD34, CD117, CD71, HLA-DR, CD13, dim CD33 along with positive myeloperoxidase. Subsequently, she started receiving continuous IV infusion of cytarabine 100 mg/m2days 1−7 and idarubicin. She achieved a complete remission...