Table 2.

Comparative efficacy of epoetin alfa-epbx and epoetin alfa, evaluated by coprimary efficacy end points of mean weekly hemoglobin level and mean weekly epoetin dose by body weight

AnalysisEpoetin alfa-epbxEpoetin alfa
Primary analysis (ITT population)n=306n=306
 Mean weekly hemoglobin level during last 4 wk of treatment, g/dl
  Least squares mean (SEM)10.17 (0.05)10.28 (0.05)
  Difference (95% CI)a−0.12 (−0.25 to 0.01)
 Mean weekly epoetin dose by body weight during last 4 wk of treatment, U/kg per weekb
  Least squares mean (SEM)90.16 (3.87)89.79 (3.88)
  Difference (95% CI)c0.37 (−10.40 to 11.13)
Sensitivity analysis (per protocol population)n=204n=192
 Mean weekly hemoglobin during last 4 wk of treatment, g/dl
  Least squares mean (SEM)10.19 (0.06)10.30 (0.06)
  Difference (95% CI)a−0.10 (−0.27 to 0.06)
 Mean weekly epoetin dose by body weight during last 4 wk of treatment, U/kg per week
  Least squares mean (SEM)85.71 (4.73)88.12 (4.88)
  Difference (95% CI)c−2.41 (−15.77 to 10.95)
  • ITT, intent to treat; 95% CI, 95% confidence interval.

  • a The 95% CI for the least squares mean of the difference (epoetin alfa-epbx–epoetin alfa) in mean weekly hemoglobin had to reside within the equivalence margin of ±0.5 g/dl for equivalence to be concluded.

  • b One patient in each group did not have dose data reported at baseline. Therefore, primary analysis of mean weekly epoetin dose by body weight during last 4 wk of treatment in the ITT population is on the basis of data for 305 randomized patients in each treatment group.

  • c The 95% CI for the least squares mean of the difference (epoetin alfa-epbx–epoetin alfa) in mean weekly epoetin dose per kilogram of body weight had to reside within the equivalence margin of ±45 U/kg per week for equivalence to be concluded.