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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 49-year-old woman developed chronic norovirus gastroenteritis following immunosuppressive treatment with methylprednisolone, tacrolimus, antithymocyte globulin, mycophenolate mofetil and prednisone after pancreas transplantation [not all routes and dosages stated].
The woman underwent pancreas transplantation with enteric drainage. She had creatinine level of 0.8 mg/dL prior to the operation. She received induction immunotherapy consisting of IV methylprednisolone and alemtuzumab. She also received maintenance immunotherapy consisting of sirolimus and tacrolimus. On post transplant day 386, she received antithymocyte globulin for an episode of moderate cellular rejection. Sirolimus was switched to mycophenolate mofetil 1000mg two times a day. On post transplant day 841, she...