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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 report described one 78-year-old man and one 72-year-old woman, who developed myositis or necrotising myositis during treatment with pembrolizumab [routes, dosages, duration of treatment to reaction onsets not stated].
Case 1: The 78-old-year man developed myositis during treatment with pembrolizumab. He had a medical history of urinary cancer and presented with generalised weakness. Subsequently, he was diagnosed with renal, pelvis, and ureter cancer with multiple metastases of lymph nodes 2 years prior to the present consultation. His tumour worsened, despite the treatment with vinblastine, doxorubicin [adriamycin], cisplatin, gemcitabine and methotrexate. Subsequently, he started receiving pembrolizumab for the enlargement of lymph nodes. At the second course of...
- Kamo H, et al. Pembrolizumab-related systemic myositis involving ocular and hindneck muscles resembling myasthenic gravis: A case report. BMC Neurology 19: 184, No. 1, 5 Aug 2019. Available from: URL: http://doi.org/10.1186/s12883-019-1416-1 - Japan