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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
The male patient in his second decade of life [exact age at the time of reactions onsets not stated], who exhibited treatment failure with cladribine; developed nocardia pneumonia and tumor hemorrhages during treatment with ifosfamide, carboplatin, etoposide, prednisolone and cladribine; sepsis, catheter related infection, vitreous hemorrhage of the left eye, emphysema in the intestinal tract, peritoneal cavity emphysema, mediastinum emphysema, gastrointestinal haemorrhage and elevation of pancreatic enzymes during treatment with ifosfamide, carboplatin, etoposide and prednisolone; skin adverse event and hepato-biliary enzymes elevation during treatment with trametinib; and also developed fatal small-intestinal perforations during treatment with prednisolone [not all dosages,...
- Kumamoto T, et al. A case of recurrent histiocytic sarcoma with MAP2K1 pathogenic variant treated with the MEK inhibitor trametinib. International Journal of Hematology 109: 228-232, No. 2, Feb 2019. Available from: URL: http://doi.org/10.1007/s12185-018-2553-9 - Japan