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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 boy [exact age at reactions onsets not stated] developed multiple infections, including two episodes of urinary tract infections, herpes labialis, Candida infection, positive serum PCR for cytomegalovirus, BK virus-associated nephropathy (BKVAN) and BK virus pneumonia during immunosuppression therapy with basiliximab, mycophenolate mofetil, prednisolone and tacrolimus following renal transplantation.
The boy, who was diagnosed with nephrotic syndrome at 8 years of age, progressed to end-stage renal disease over the years. His medical history was significant for meningitis, and use of prednisolone, ciclosporin [Cyclosporin A] and cyclophosphamide. Therefore, at the age of 15 years, he underwent renal transplantation. Immunosuppression therapy comprised basiliximab as induction...