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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 single-centre cohort study of 90 pediatric patients, four patients [ages and sexes not stated] were described, who developed hepatitis E virus replication during treatment with immunosuppressants such as mycophenolate mofetil, tacrolimus or unspecified steroids [routes and durations of treatments to reactions onsets not stated].
Patient 1: A patient developed hepatitis E virus replication following treatment with immunosuppressants such as mycophenolate mofetil, tacrolimus and unspecified steroids. The patient, who had undergone a renal transplant, started receiving triple immunosuppressive regimen consisting of tacrolimus, mycophenolate mofetil and unspecified steroids. Subsequently, the patient was diagnosed with hepatitis E virus replication. After the diagnosis,...