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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 study of 150 patients, 3 patients (1 woman) [not all sexes stated] aged 41−56 years were described, who developed febrile neutropenia and neutropenic typhlitis following treatment with docetaxel and epirubicin for breast cancer. Of these three patients, the 42-year-old woman also experienced drug toxicity and died due to neutropenic typhlitis.
Patient 1: The 42-year-old woman, who had breast cancer stage II, was initiated on the first course of chemotherapy with IV docetaxel 75 mg/m2 and IV epirubicin 75 mg/m2every three weeks. Eight days after receiving the first course, she presented to the emergency room due to diverse symptoms. She presented with grade 4 febrile neutropenia despite receiving prophylactic therapy with pegfilgrastim. Her symptoms included grade 3...