Stomatitis, rash, diarrhoea, and fatigue were the most commonly reported adverse events but were largely mild or moderate in severity. Grade 3 or 4 stomatitis was detected in 14 (7%) of patients. Infections occurred in 23% vs 6% in everolimus and placebo groups respectively. Only 2% of infections in the everolimus group were grade 3 or 4 events. Pneumonitis was detected in 35 (17%) of patients of which 2% were grade 3 or higher.r
Discontinuation due to adverse events occurred in 13% of the patients receiving everolimus with pneumonitis, fatigue, and interstitial lung disease as the most common reasons.
During the study 7 patients who received everolimus died due to reasons other than disease progression. Of these, 1 patient died as a result of everolimus related treatment toxicity with acute respiratory distress syndrome.r
© New England Journal of Medicine 2011