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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 man in his 20s [age at the time of reaction onset not stated] developed secondary B-acute lymphoblastic leukaemia (B-ALL) following treatment with daunorubicin, etoposide and ifosfamide, and sepsis and fatal multiorgan failure following treatment with vincristine, navitoclax, venetoclax, dexamethasone and asparaginase for B-ALL [routes, dosages and times to reactions onsets not stated; not all outcomes stated].
The man presented with fever in 2009 (at the age of 18 years). At presentation, investigation revealed B-ALL. He had been diagnosed with hepatoblastoma at the age of 2 years, and had received multiple chemotherapeutic agents. Subsequently, he developed lung metastasis, which was managed with unspecified platinum-based chemotherapy, radiation, autologous stem cell...
- Li N, et al. Relapsed B-acute lymphoblastic leukemia with aberrant myeloperoxidase expression following CAR T-cell therapy: A diagnostic challenge. American Journal of Hematology 94: 1049-1051, No. 9, Jan 2019. Available from: URL: https://doi.org/10.1002/ajh.25478 - USA