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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug overdose
In a retrospective cohort study of 181 paediatric patients newly diagnosed with acute lymphoblastic leukaemia (ALL) in Mexico, between January 2015 and December 2017, 3 children (2 boys and 1 girl) aged 4 years and 11 months−10 years were described, who developed acute pancreatitis, ototoxicity, gastrointestinal disorders, multiple organ failure or septic shock during treatment with asparaginase, daunorubicin, prednisone, vincristine or unspecified corticosteroids for ALL. Amongst these, 2 patients had a fatal overdose of cyclophosphamide (n=1) and prednisone (n=1) secondary to medication error [not all routes, duration of treatments to reactions onset and outcomes not stated].
Case 1: A 5-year-old boy developed fatal septic shock and gastrointestinal disorders...
- Vazquez-Cornejo E, et al. Medication errors in a cohort of pediatric patients with acute lymphoblastic leukemia on remission induction therapy in a tertiary care hospital in Mexico. Cancer Medicine 8: 5979-5987, No. 13, Oct 2019. Available from: URL: http://doi.org/10.1002/cam4.2438 - MexicoCrossRefGoogle Scholar