Fig. 3: Key secondary efficacy end points by day +180 after allo-HSCT.

a–e, KM estimates for the secondary efficacy end points. Analyses included all randomized patients who received ≥1 dose of study treatment and allo-HSCT. In the fixed-sequence hierarchical testing procedure, once 1 efficacy end point was not significant (P ≥ 0.05), testing of subsequent end points was not performed. P values were obtained using a log-rank test unless otherwise stated. All statistical tests were two-sided. *P value is significant for vedolizumab versus placebo. ^†HR and 95% CI values were obtained from a Cox proportional hazards model with treatment group stratified by randomization strata: HLA match (7 of 8 or 8 of 8), conditioning regimen (MAC or RIC) and ATG (with or without). ^‡Time to first documented lower-GI aGVHD, relapse of underlying malignancy or death from any cause. ^§Sensitivity analysis, excluding lower-GI aGVHD events classified as clinical grade 0 or unknown. ^¶NRM was a competing risk in this competing risk sensitivity analysis; P value for comparison of vedolizumab with placebo was obtained by a Gray’s test. ^‖Time to first documented IBMTR grade C–D aGVHD (any organ) or death from any cause. ^**Death and relapse were competing risks in this sensitivity analysis; an event was defined as IBMTR grade C–D aGVHD (any organ) or death. P value was obtained by a Gray’s test. ^††Death from first dose of study treatment without occurrence of a relapse. ^‡‡Relapse was a competing risk in this sensitivity analysis; NRM was the time from first study treatment to death without occurrence of a relapse; P value was obtained by a Gray’s test. ^§§Overall survival by day +180 was the analysis of the time from the first dose of study treatment to death from any cause. All deaths were defined as events in this analysis. ^¶¶Time to first documented IBMTR grade B–D aGVHD (any organ) or death from any cause. ^‖‖Death and relapse were competing risks in this sensitivity analysis; an event was defined as IBMTR grade B–D aGVHD (any organ) or death. P value was obtained by a Gray’s test.