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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, five patients (four women and one man) aged 64−73 years, including an elderly man [exact age at reaction onset not stated] were described, of whom four patients developed myasthenia gravis, optic neuritis or cardiotoxicities, including myocarditis, following treatment with nivolumab or pembrolizumab. The remaining patient developed cardiotoxicities including myocarditis and acute myasthenia crisis following off-label treatment with pembrolizumab for malignant mesothelioma [not all routes, dosages, times to reactions onsets and outcomes stated].
Case 1: A 73-year-old man, who had stage-III malignant mesothelioma (mixed epithelioid, sarcomatoid, and desmoplatstic types), received one dose of off-label IV pembrolizumab infusion 200mg due to disease progression....