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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 case series described three women aged 58−65 years, who developed pseudo-cirrhosis during treatment with bevacizumab, capecitabine, cyclophosphamide, epirubicin, eribulin, exemestane, fulvestrant, gemcitabine, letrozole, paclitaxel, toremifene, vinorelbine or an unspecified mTOR-protein-inhibitor [mammalian target of rapamycin inhibitor] for metastatic invasive ductal carcinoma of the breast [routes and outcomes not stated; not all dosages stated; duration of treatment to reactions onsets not clearly stated].
Case 1: A 65-year-old woman, who developed pseudo-cirrhosis during treatment with epirubicin, cyclophosphamide, capecitabine, letrozole, fulvestrant, exemestane, toremifene, paclitaxel, bevacizumab, gemcitabine, vinorelbine and an unspecified mTOR-protein-inhibitor. The...