Table 3 Mean change in weekly dose/kg body weight between the baseline and evaluation periods in the PPS
PDA-10 (n = 136) | Eprex® (n = 120) | |
|---|---|---|
Mean baseline epoetin dosage (IU/kg/week) | 107.52 (69.18) | 114.58 (73.86) |
Mean evaluation epoetin dosage (IU/kg/week) | 117.53 (81.35) | 104.28 (65.87) |
Mean absolute change in epoetin dose (IU/kg/week) | 10.01 (44.64) | −10.30 (56.09) |
Least Square mean difference of “PDA10 – Eprex®” | ||
LS mean | 9.55 (4.81) | −8.71 (4.82) |
LS mean for difference | 18.26 (6.02) | |
95% one-sided lower limit (≥ − 0.5) (p value) | 8.31 (< 0.0001) | |
95% one-sided upper limit (≤ + 0.5) (p value) | 28.21 (< 0.0001) | |