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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 5-year-old girl developed posterior reversible encephalopathy syndrome and BK virus nephropathy following immunosuppressive treatment with basiliximab, methylprednisolone, mycophenolate mofetil, tacrolimus and prednisone. She also developed systemic BK virus infection during treatment with cyclophosphamide, doxorubicin, prednisone, rituximab and vincristine; acute kidney injury secondary to tacrolimus toxicity and cidofovir; and cytopenia during treatment with leflunomide [not all routes, dosages and outcomes stated; duration of treatments to reactions onset not stated].
The girl was diagnosed with dilated cardiomyopathy at four months of age and scheduled for heart transplant. Two months prior to transplantation, she underwent cardiac pulmonary resuscitation for cardiac...