ORR. (A) ORR at day 28. (B) Durable overall response at day 56. (C) Overall response rate at day 14. (D) Organ response at day 28. Full analysis set. (A and C) ORR is defined as the proportion of patients achieving CR or PR. (B) Durable ORR at day 56 is defined as the proportion of patients who achieved a CR or PR at day 28 and maintained a CR or PR at day 56. The 2-sided 90% CI for the response rate was calculated using the Clopper-Pearson exact method. (D) Baseline involvement if respective stage at baseline is >0. n, number of patients with the respective organ response; N, number of patients in the treatment group; N1, number of patients with the respective organ involvement at baseline excluding patients in n with change/addition of new systemic GVHD treatment by day 28 who have a reduction in organ stage of ≥1; y, years.
