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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 case series, six patients including two girls, three boys and one man [aged 9−24years] were described, who developed hepatotoxicity during treatment with pegaspargase [PEG-asparaginase] for acute B-lymphoblastic leukaemia (B-ALL).
Case 1: An 11-year-old boy, who was newly diagnosed with high risk B-ALL, started receiving induction therapy comprising IV pegaspargase 2500 IU/m2on day 4, vincristine, daunorubicin, prednisone , cytarabine and methotrexate. On day 22 of the induction therapy (18 days after the initiation of pegaspargase), he presented with peripheral oedema, weakness, jaundice and scleral icterus. He had a total bilirubin level of 16.6 mg/dL, conjugated bilirubin level of 11.3 mg/dL, suggesting grade 4 hyperbilirubinaemia. His AST and ALT...
- Schulte RR, et al. Levocarnitine for asparaginase-induced hepatic injury: a multi-institutional case series and review of the literature. Leukemia and Lymphoma 59: 2360-2368, No. 10, 3 Oct 2018. Available from: URL: http://doi.org/10.1080/10428194.2018.1435873 - USA