The cumulative incidences at 12 months of intestinal GvHD stage > 2 with death as a competing event ( budesonide 20.8 % vs. placebo 32.6 % , p = 0.250 ) and the cumulative incidence of relapse ( budesonide 20.8 % vs. placebo 16.3 % , p = 0.547 ) and non-relapse mortality ( budesonide 28 % ( 95 % CI 15-41 % ) vs. placebo 30 % ( 95 % CI 15-44 % ) , showed no significant difference within the two groups ( p = 0.911 ) .