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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 57-year-old woman developed low level BK polyomavirus (BKPyV) infection associated with high-grade metastatic sarcomatoid urothelial carcinoma with urothelial carcinoma in situ during treatment with methylprednisolone, mycophenolate-mofetil and tacrolimus used as an immunosuppressants [routes not stated; duration of treatments to reactions onset not stated].
The woman, who had a chronic kidney failure, underwent a kidney transplant from a deceased donor. Thereafter, she started receiving immunosuppressive treatment with methylprednisolone 4mg daily, mycophenolate mofetil 500mg twice a day and tacrolimus 5mg twice a day. The immunosuppressants dosages were dynamically adjusted to maintain target serum concentrations. Notably, she had a long-term BKPyV infection. The BKPyV...
- Fu F, et al. Occurrence and regression of BK polyomavirus associated carcinoma: A clinical and next-generation sequencing study. Clinical Science 132: 1753-1763, No. 16, 30 Aug 2018. Available from: URL: http://doi.org/10.1042/CS20180443 - China