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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 43-year-old woman experienced late-onset gastroduodenitis and cholangitis during treatment with nivolumab for cutaneous metastatic melanoma, and she developed Staphylococcus aureus bacteraemia during treatment with methylprednisolone and unspecified corticosteroids for the nivolumab-induced gastroduodenitis and cholangitis.
The woman was diagnosed with superficially spreading cutaneous melanoma on her right ear in 2012. She subsequently underwent wide excision surgery. However, she later experienced unresectable BRAF wild-type regional and subcutaneous recurrence. Therefore, in November 2016, she started receiving IV infusion of nivolumab 3 mg/kg every 2 weeks. Four months later, she achieved complete remission. However, 2 weeks prior to her twenty-sixth nivolumab infusion,...