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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 32-year-old woman developed hyperammonaemic encephalopathy following chemotherapy with nivolumab. Thereafter, she developed a second episode of hyperammonaemic encephalopathy following treatment with dexamethasone and rovalpituzumab tesirine [routes not stated; not all dosages and durations of treatments to reaction onset stated].
The woman, who had recurrent metastatic fibrolamellar hepatocellular carcinoma (fHCC) status post surgical resection, was referred for progressive confusion over a week. Recently, she had received nivolumab. Nivolumab was stopped considering a possibility of nivolumab-induced autoimmune hepatitis.
The woman was then hospitalised with mental status changes and received treatment with levetiracetam and unspecified steroids considering a possibility of...
- Cho J, et al. Hyperammonemic encephalopathy in a patient with fibrolamellar hepatocellular carcinoma: Case report and literature review. Journal of Gastrointestinal Oncology 10: 582-588, No. 3, Jun 2019. Available from: URL: http://doi.org/10.21037/jgo.2019.01.28 - USA