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Various toxicities: 19 case reports In an interim analysis of 112 patients of a post-marketing surveillance, treated between June 2016 to September 2017, 19 patients [ages and sexes not stated] were described, who developed rash and blood creatine phosphokinase increased (9 patients), iron deficiency anaemia (1 patient), uveitis (2 patients), dermatitis acneiform (1 patient), blood lactate dehydrogenase increased (1 patient), putamen haemorrhage (1 patient), metastases to the skin (1 patient), alopecia (1 patient) or disease progression (2 patients) during treatment with dabrafenib and trametinib for metastatic melanoma with BRAF V600 mutation. The patients, who had metastatic melanoma with BRAF V600 mutation, were started on dabrafenib and trametinib daily [routes and doses not stated]. Subsequently, they developed rash and blood creatine phosphokinase increased, iron deficiency anaemia, uveitis, dermatitis acneiform, blood lactate dehydrogenase increased, putamen haemorrhage, metastases to the skin, alopecia or disease progression [durations of treatments to reactions onsets not stated]. The patients, who developed putamen haemorrhage, iron deficiency anaemia, uveitis, dermatitis acneiform and blood lactate dehydrogenase increased were found to be not recovered. Whereas, the patient, who had disease progression, died due to it [not all outcomes stated]. Teshima Y, et al. Interim analysis for post-marketing surveillance of dabrafenib and trametinib combination therapy in Japanese patients with unresectable and metastatic melanoma with BRAF V600 mutation. International Journal of Clinical Oncology 25: 1870-1878, No. 10, 22 Jul 2020. Available from: URL: http://doi.org/10.1007/ 803519532 s10147-020-01737-3

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Reactions 5 Dec 2020 No. 1833