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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case report, a 67-year-old woman developed severe haemorrhagic cystitis following treatment with cyclophosphamide, capecitabine and doxorubicin for metastatic breast cancer, and a 65-year-old woman developed severe haemorrhagic cystitis following treatment with cyclophosphamide and capecitabine for metastatic breast cancer.
Case 1: The 67-year-old woman had undergone an axillary lymph node dissection and a left mastectomy for left breast cancer at 45 years of age. Postoperatively, radiotherapy was administered to the residual breast. After 13 years, a right lung metastasis was observed. As first-line chemotherapy, she received over six courses of AC regimen comprising doxorubicin [adriamycin] 60 mg/m2 and cyclophosphamide 600 mg/m2 [routes not stated]. With...
- Tanaka T, et al. Severe Hemorrhagic Cystitis Caused by Cyclophosphamide and Capecitabine Therapy in Breast Cancer Patients: Two Case Reports and Literature Review. Case Reports in Oncology 12: 69-75, No. 1, Jan-Apr 2019. Available from: URL: http://doi.org/10.1159/000496331 - Japan