The crude incidence of histological or clinical stage 3-4 acute intestinal GvHD until day 100 observed in 91 ( n = 48 budesonide , n = 43 placebo ) evaluable patients was 12.5 % ( 95 % CI 3-22 % ) under treatment with budesonide and 14 % ( 95 % CI 4-25 % ) under placebo ( p = 0.888 ) .