The most frequently reported grade 3 or 4 adverse events in the everolimus group versus the placebo group were neutropenia ( 117 [ 25 % ] vs 35 [ 15 % ] ) , stomatitis ( 59 [ 13 % ] vs three [ 1 % ] ) , anaemia ( 46 [ 10 % ] vs six [ 3 % ] ) and diarrhoea ( 43 [ 9 % ] vs 10 [ 4 % ] ) On-treatment adverse event-related deaths were reported in 17 ( 4 % ) patients in the everolimus group and none in the placebo group .