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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
Three women aged 55−68 year were described, who developed atypical femoral fracture (AFF) and two amongst them additionally developed osteonecrosis of jaw (ONJ) following treatment with trastuzumab, zoledronic acid [zoledronate], trastuzumab-emtansine [TDM1] or denosumab for breast cancer [dosages and routes not stated; not all outcomes stated].
Case 1: A 68-year-old woman, who had breast cancer (T3N2M0) underwent quadrantectomy of the right breast with axillary lymph node (LN) dissection in May 2006. Subsequently, she received four cycles of trastuzumab along with docetaxel and concomitant radiotherapy every three weeks until November 2007. In December 2007, her cancer relapsed. Therefore, she again received chemotherapy with trastuzumab, carboplatin and paclitaxel....
- Kordoni M, et al. Atypical Femoral Fractures (AFF) from Bone Remodeling Agents in Patients with Cancer. Anticancer Research 38: 6439-6444, No. 11, Nov 2018. Available from: URL: http://doi.org/10.21873/anticanres.13005Google Scholar