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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 28-year-old man developed fatal neutropenic enterocolitis caused by Stenotrophomonas maltophilia during treatment with azacitidine, beclometasone [beclomethasone dipropionate], busulfan, ciclosporin [cyclosporine A], cyclophosphamide, cytarabine, etoposide, meropenem, gemtuzumab-ozogamicin, methotrexate, methylprednisolone, mitoxantrone, mycophenolate mofetil, tacrolimus and vancomycin [routes not stated; not all dosages and indications stated].
The man, who had acute myeloid leukaemia, underwent peripheral blood stem cell transplantation (PBSCT). He received conditioning regimen included busulfan 12.8 mg/kg and cyclophosphamide 120 mg/kg. He also received ciclosporin and short-term methotrexate for GVHD prophylaxis; however, he developed grade I acute graft versus host...
- Kaito S, et al. Fatal neutropenic enterocolitis caused by stenotrophomonas maltophilia: A rare and underrecognized entity. Internal Medicine 57: 3667-3671, No. 24, 2018. Available from: URL: http://doi.org/10.2169/internalmedicine.1227-18 - Japan