The most prominent grade 3 or 4 events in the everolimus group were stomatitis (8%), anemia (6%), fatigue (4%), dyspnea (4%), hyperglycemia (4%), and pneumonitis (3%).[ 27 ] OS did not reach statistical significance although trended toward favoring the everolimus group (median OS 31 months in the everolimus groups vs. 26.6 months in the placebo group, P = 0.14);[ 10 ] however, the study was not powered to detect a 4–5 months OS difference.
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