Fig. 2: Lower-GI aGVHD-free survival by day +180 after allo-HSCT. | Nature Medicine

Fig. 2: Lower-GI aGVHD-free survival by day +180 after allo-HSCT.

From: Vedolizumab for the prevention of intestinal acute GVHD after allogeneic hematopoietic stem cell transplantation: a randomized phase 3 trial

Fig. 2

Analysis included all randomized patients who received ≥1 dose of study treatment and received allo-HSCT. All statistical tests were two-sided. a, Graph shows number and proportion of patients with a lower-GI aGVHD event or death; censored for patients who had not had the lower-GI aGVHD event or died or had the event after a prespecified time, for example, last contact or day +180 after allo-HSCT, whichever occurred first. If a patient had a lower-GI aGVHD event and died due to any cause, including lower-GI aGVHD, the time to event was derived as the time to the first qualifying event (lower-GI aGVHD event). b, Frequency of lower-GI aGVHD by maximum clinical stages 0–4 by day +180 after allo-HSCT for patients in vedolizumab and placebo treatment groups and also the corresponding frequency of skin aGVHD and liver aGVHD in these treatment groups by maximum clinical stages 0–4 by day +180 after allo-HSCT. CI was based on the Clopper–Pearson method. c, KM estimate for the primary study end point lower-GI aGVHD-free survival from first study treatment (day −1) to lower-GI aGVHD event or death due to any cause. Red line shows the vedolizumab group; blue line shows the placebo group; open circles indicate censored patients. HR obtained via a Cox proportional hazards model with treatment group, stratified by randomization stratification factors: HLA match (7 of 8 or 8 of 8), conditioning regimen (MAC or RIC), ATG (with or without) and P value from a log-rank test (P = 0.0009). d, Forest plot of prespecified subgroup analyses for the primary study end point of lower-GI aGVHD-free survival by day +180 after allo-HSCT: conditioning regimen MAC or RIC, with or without ATG, CNI TAC or CYS, HLA match, and stem cell source peripheral blood or bone marrow. HRs plotted with 95% CIs were obtained via a Cox proportional hazards model with treatment group stratified by randomization strata. Results for the remaining prespecified subgroup analyses are shown in Extended Data Fig. 1.

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