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Table 4 Mean change in hemoglobin levels (g/dL) from baseline to week-4

From: Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial

Statistics

ITT Population (N = 126)

PP Population (N = 93)

Darbepoetin alfa (n = 63)

Erythropoietin alfa (n = 63)

Darbepoetin alfa (n = 47)

Erythropoietin alfa (n = 46)

Baseline

 n

56

53

47

46

 Mean (SD)

8.39 (0.90)

8.80 (0.89)

8.39 (0.85)

8.72 (0.91)

Week-4

 n

55

50

47

45

 Mean (SD)

8.66 (1.24)

9.50 (1.81)

8.68 (1.13)

9.62 (1.71)

Within group comparison

p-value*

0.0566

0.0019

0.0473

0.0002

 Mean change

0.30

0.74

0.29

0.91

 95% CI

[−0.01–0.61]

[0.29–1.19]

[0.00–0.57]

[0.45–1.36]

Between group comparison

 Mean change

−0.44

−0.62

 95% CI

[−0.97–0.09]

[−1.14−0.10]

 p-value**

0.1057

0.0209

  1. n number of subject at each visit; N total number of subjects, ITT Intent to treat, PP Per protocol
  2. * p-value were obtained using Paired t Test for mean (two tailed, a = 0.05)
  3. **p-value were obtained using Unpaired t Test for mean change (two tailed, a = 0.05)
  4. Note: Patients taken where Hb < 10 at Screening