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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 64-year-old man developed focal segmental glomerulosclerosis (FSGS) and thrombotic microangiopathy (TMA) during treatment with sorafenib for recurrent hepatocellular carcinoma.
The man, who had hepatitis-C virus infection, hepatocellular carcinoma, mild proteinuria and mild chronic kidney disease (CKD), underwent orthotopic liver transplant (OLT) in August 2013. Post-OLT, he started receiving tacrolimus. He was suspected to have hepato-renal syndrome and contrast induced nephropathy. In the middle of November 2013, he was diagnosed with recurrent hepatocellular carcinoma and subsequently started receiving oral sorafenib [dosage not stated]. Just before initiation of sorafenib, his serum creatinine had decreased to a nadir. Prior to initiation of sorafenib, a urinalysis...
- Hanna RM, et al. Development of Focal Segmental Glomerulosclerosis and Thrombotic Microangiopathy in a Liver Transplant Patient on Sorafenib for Hepatocellular Carcinoma: A Case Report. Transplantation Proceedings 50: 4033-4037, No. 10, Dec 2018. Available from: URL: http://doi.org/10.1016/j.transproceed.2018.07.020 - USA