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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 case series, three patients (two women and one man) aged 58−72 years were described, who developed invasive pulmonary aspergillosis during treatment with ibrutinib, imatinib or bosutinib [routes not stated].
A 63-year-old woman developed invasive pulmonary aspergillosis secondary to Aspergillus fumigatus during treatment with ibrutinib for chronic B-cell lymphocytic leukaemia (CLL). She started receiving treatment with ibrutinib 420mg once a day for CLL. She had received chemotherapy prior to the initiation of ibrutinib. Prior to the initiation of ibrutinib, she had received ofatumumab for 4 months, which she discontinued because of increase in white cell count due to an unknown aetiology. On day +10 of ibrutinib therapy, she presented with cough productive of yellow...
- Nasir T, et al. Invasive aspergillosis complicating treatment with tyrosine kinase inhibitors. BMJ Case Reports 12: No. 1, 29 Jan 2019. Available from: URL: http://doi.org/10.1136/bcr-2018-226121 - United Kingdom