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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 27-year-old man developed Aspergillus pneumonia and invasive pulmonary aspergillosis fumigatus during treatment with prednisolone for skin graft-versus host disease (GVHD) grade IV, and developed resistance in Aspergillus fumigatus infection during treatment with posaconazole for fungal prophylaxis and later for Aspergillus fumigatus infection [routes not stated].
The man, who had relapsed acute lymphoblastic leukaemia (ALL), received second matched unrelated donor haematopoietic stem cell transplantation. He was started on posaconazole 300 mg tablet every 12 hours for two doses and then 300mg once a day for fungal prophylaxis. He had been receiving posaconazole for 77 days from the outpatient clinic. Later, he was hospitalised for aggravated skin GVHD grade IV and started...
- Lee H-J, et al. TR34/L98H Mutation in CYP51A Gene in Aspergillus fumigatus Clinical Isolates During Posaconazole Prophylaxis: First Case in Korea. Mycopathologia 183: 731-736, No. 4, Aug 2018. Available from: URL: http://doi.org/10.1007/s11046-018-0271-8 - South Korea