Toxicity
The most common AEs that led to treatment discontinuation (with n≥2) included muscle spasm, weight loss and dysgeusia. All patients experienced treatment-emergent adverse events (TEAEs); however, these were mild to moderate (grade ≤ 2) in almost half the patients. Commonly reported TEAEs, occurring in 20% or more of patients included muscle spasm (71.2%), alopecia (65.4%), dysgeusia (53.8%), weight loss (50%), fatigue (40.4%) and nausea (32.7%). Amenorrhoea was reported in 2 out of 6 women of childbearing potential. In those patients who developed AEs, common AEs with the shortest median time to onset included muscle spasm (1.89 months), dysgeusia (1.48 months), nausea (2.14 months), fatigue (2.79 months), and decreased appetite (2.87 months). 24 patients died during the study period. None of the deaths were considered related to the study treatment by investigators.r
© New England Journal of Medicine 2012