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. 2023 Oct 28;65:102273. doi: 10.1016/j.eclinm.2023.102273

Table 2.

Primary and secondary efficacy endpoint (PPS population).

Outcome Pegmolesatide
Epoetion alfa
Difference (95% CI) P value
Value Value
Primary efficacy endpoint–dL
 Mean change in Hb level from baseline to wk 1724 0.07 (0.92)a −0.22 (0.97)a 0.29 (0.11, 0.47) 0.0018
Secondary efficacy endpoint–no. (%)
 Proportion of patients with ΔHb maintained within ±1.0 dL during wk 1724 149 (64.0) 68 (59.7) 4.2 (−6.6, 15.1) 0.45
 Proportion of patients with Hb stayed within 10.0–12.0 dL during wk 1724 158 (67.8) 82 (71.9) −4.0 (−14.2, 6.3) 0.45

PPS population included patients who completed at least three hemoglobin measurements during efficacy evaluation period and had no major violation of study protocol. For the primary efficacy endpoint, difference was analyzed with least square mean. ΔHb was defined as the mean change in hemoglobin values from baseline to the efficacy evaluation period.

Abbreviation: Hb, hemoglobin.

a

Mean (SD).