Extended Data Table 4 Results summary for main exploratory efficacy end points – by day +365
- Results of the main exploratory study end points analyzed by day+365 after allo-HSCT. Analyses included all randomized patients who received ≥1 dose of study treatment and allo-HSCT. All statistical tests were two-sided.
- * Number (%) of patients with an observed event/relapse/death (as applicable), whichever occurred first, from first study treatment dose (day −1) through day +365.
- † Obtained via log-rank test unless otherwise stated.
- ‡ Obtained via Cox proportional hazards model with treatment group, stratified by randomization stratification factors: HLA match (7/8, 8/8), conditioning regimen (Myeloablative, Reduced Intensity), ATG (With, Without) unless otherwise stated.
- § Competing risk analysis with relapse and death as competing risks. P-value obtained by Gray’s test.
- ¶ GVHD and relapse-free survival was the time from the date of first study treatment dose (day-1) to GVHD event/death/relapse, where an event is defined as death or aGVHD grade 3–4 by modified Glucksberg criteria9 (Supplementary Table 2) or chronic GVHD requiring system immunosuppression or relapse.
- ‖Competing risk analysis with death as competing risk. P-value obtained by Gray’s test.
- ** Hazard ratio obtained via Cox proportional hazards model with treatment group adjusting for complete remission status and randomization stratification factors: HLA match or mismatch (8/8 or 7/8), Conditioning Regimen (Myeloablative, Reduced Intensity), and ATG (With, Without).
- ††P-value for comparison between vedolizumab and placebo was obtained using Wilcoxon rank-sum test. Allo-HSCT, allogenic hematopoietic stem cell transplantation; ATG, anti-thymocyte globulin; HLA, human leukocyte antigen; GVHD, graft-versus-host disease; MAGIC, Mount Sinai Acute GVHD International Consortium (Harris AC, et al. Biol Blood Marrow Transplant 2016;22:4-10).
