Supplemental Material related to "Phase 2 randomized controlled trial of serlopitant, a neurokinin 1 receptor antagonist for chronic pruritus in epidermolysis bullosa. U Okata-Karigane et al., 2022"
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Supplemental Material related to "Phase 2 randomized controlled trial of serlopitant, a neurokinin 1 receptor antagonist for chronic pruritus in epidermolysis bullosa. U Okata-Karigane et al., 2022" Supplemental Figure S1. Participant flow in the double-blind phase and open-label extension study. Supplemental Figure S2. The change in the Static Participant Assessment of Itch (SPAI) at month 2. Supplemental Figure S3. Monthly NRS change in the open-label extension study. Supplemental Table S1. Detailed inclusion and exclusion criteria. Supplemental Table S2. Detailed masking and blinding. Supplemental Table S3. A linear mixed model analysis for relative weekly NRS change. Supplemental Table S4. Patient Global Impression of Change at month 2. Supplemental Table S5. Minimal Clinically Important Difference (MCID) for the Average Itch NRS based on PGIC. Supplemental Table S6. Changes in quality of life or pruritus-related questionnaires at month 2 from baseline. Supplemental Table S7. Detailed open-label extension.
与《司洛匹坦(serlopitant)——一种用于治疗大疱性表皮松解症(epidermolysis bullosa)慢性瘙痒的神经激肽1受体拮抗剂(neurokinin 1 receptor antagonist)的II期随机对照试验》相关的补充材料,原文作者为U Okata-Karigane等人,发表于2022年。 补充图S1:双盲阶段与开放标签扩展研究的受试者入组流程 补充图S2:第2个月时静态瘙痒受试者评估(Static Participant Assessment of Itch, SPAI)的变化 补充图S3:开放标签扩展研究中的月度数字评分法(Numerical Rating Scale, NRS)变化 补充表S1:详细的纳入与排除标准 补充表S2:详细的盲法实施细节 补充表S3:每周相对数字评分法(NRS)变化的线性混合模型分析 补充表S4:第2个月时的患者整体印象改善量表(Patient Global Impression of Change, PGIC)结果 补充表S5:基于患者整体印象改善量表(PGIC)的平均瘙痒数字评分法(NRS)的最小临床重要差异(Minimal Clinically Important Difference, MCID) 补充表S6:基线至第2个月时生活质量或瘙痒相关问卷的得分变化 补充表S7:开放标签扩展研究的详细信息



