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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 single-centre, retrospective case-series of 32 patients conducted between June 2014 and June 2016, four patients including one man and two women [not all ages and sexes stated] were described, who developed infusion related reactions, new-onset atrial flutter, palpitations or acute heart failure exacerbation during treatment with carfilzomib (2 patients) and carfilzomib and doxorubicin (2 patients) [indications and outcomes not stated; not all routes, dosages and durations of treatments to reactions onsets stated]. The dosages of carfilzomib were ranged between 27−56 mg/m2 and was off label.
This report describes the patient who received five infusions of carfilzomib for 20-minute each. Eventually, the patient switched to 30-minute infusions and developed infusion related...