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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 study described three patients [two male and one female patient; exact ages at reaction onsets not stated], of whom one male patient developed hepatic fibrosis and hepatocellular carcinoma following treatment with prednisone, azathioprine and mycophenolate mofetil. The female patient developed hepatic fibrosis and hepatitis B (HBV) reactivation following treatment with everolimus, mycophenolic acid or sofosbuvir, and the remaining male patient developed hepatic fibrosis and HBV reactivation following treatment with prednisone, mycophenolate mofetil, tacrolimus, sofosbuvir or ledipasvir [routes not stated; not all dosages, duration of treatments to reaction onsets and outcomes stated].
Case 1: A male patient, who born in 1956, had kidney transplantation in 1975. He was on...