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Table 2 Mean change in Hb level from baseline to evaluation periods in the PPS

From: A multicentre, multi-national, double-blind, randomised, active-controlled, parallel-group clinical study to assess the safety and efficacy of PDA10 (Epoetin-Alfa) vs. Eprex® in patients with anaemia of chronic renal failure

 

PDA-10 (n = 136)

Eprex® (n = 120)

Mean baseline Hb (SD) (g/dl)

11.011 (0.577)

11.001 (0.587)

Mean evaluation Hb (SD) (g/dl)

10.835 (0.811)

10.883 (0.985)

Mean absolute Hb change (SD) (g/dl)

−0.176 (0.914)

−0.118 (1.114)

Least Square mean difference of “PDA10 – Eprex®”

LS mean

−0.259 (0.088)

−0.194 (0.089)

LS mean for difference

−0.066 (0.111)

95% one-sided lower limit (≥ − 0.5) (p value)

−0.249 (<.0001)

95% one-sided upper limit (≤ + 0.5) (p value)

0.117 (<.0001)

  1. SD standard deviation, LS least square, Hb haemoglobin