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 17–24 | 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 17–24 | 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 17–24 | 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.
Mean (SD).