[Translation] A modified version of the International Prognostic Scoring System (IPSS-R) in patients who have not received erythropoiesis stimulating agents (ESAs) for very low-risk, lower-risk, or intermediate-risk myelodysplastic syndromes (MDS) without transfusion dependence ( A phase 3, open-label, randomized study comparing the efficacy and safety of ACE-536 with epoetin alfa in subjects with NTD) anemia: the "ELEMENT-MDS" study
主要目的:比较罗特西普与阿法依泊汀组中较低危 NTD MDS 受试者转化为TD ( ≥3 个 单位 RBC/16 周,基于 IWG 2018)的比例
次要目的:比较罗特西普与阿法依泊汀在较低 危 NTD MDS ( 基 于 IWG 2018)受试者中的红系缓解
[Translation] Primary objective: To compare the proportion of subjects with lower-risk NTD MDS who converted to TD (≥3 units of RBC/16 weeks, based on IWG 2018) in the rotelcept versus epoetin alfa groups.
Secondary objective: To compare erythroid response with rotelcept versus epoetin alfa in subjects with lower-risk NTD MDS (based on IWG 2018)