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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 case series, 3 patients [2 men and 1 woman] aged 54−77 years were described, who developed hepatitis, colitis, liver enzyme elevation, coagulopathy, meningitis or allergic reaction while receiving nivolumab, ipilimumab, lenvatinib, pazopanib and cabozantinib for metastatic renal cell carcinoma (RCC) [routes not stated; not all dosages and durations of treatments to reactions onsets and outcomes stated].
Case 1: A 77-year-old man had a history of high blood pressure, diabetes mellitus, dyslipidaemia and chronic coronary heart disease. He had undergone a radical nephrectomy in 2011 for a localised clear-cell RCC tumour. In 2016, he developed stage IV RCC with metastases to the lungs and pancreas, and was treated with sunitinib for 16 months. Due to new progressive bone...
- Carretero-Gonzalez A, et al. Three case reports: Temporal association between tyrosine-kinase inhibitor-induced hepatitis and immune checkpoint inhibitors in renal cell carcinoma. Medicine 98: e18098, No. 47, Nov 2019. Available from: URL: http://doi.org/10.1097/MD.0000000000018098 CrossRefGoogle Scholar