Table 2. Haemoglobin end points and red blood cell transfusions.
|
Treatment group – placebo or darbepoetin alpha (μg kg−1) |
||||||||
|---|---|---|---|---|---|---|---|---|
| 0.5 QW | 1.0 QW | 2.25 QW | 4.5 QW | Placebo | 6.75 Q3W | 6.75 Q4W | 10.0 Q4W | |
| (N=6) | (N=33) | (N=33) | (N=30) | (N=22) | (N=21) | (N=21) | (N=22) | |
| Haematopoietic response | ||||||||
| Proportiona | 80 | 72 | 70 | 100 | 10 | 60 | 61 | 70 |
| (95% CI) | (45, 100) | (55, 89) | (53, 88) | (100, 100) | (0, 24) | (36, 83) | (39, 84) | (50, 91) |
| Median time to haematopoietic response (days) | 50 | 50 | 36 | 27 | NE | 57 | 36 | 40 |
| Haemoglobin response | ||||||||
| Proportiona | 80 | 69 | 67 | 92 | 5 | 58 | 49 | 60 |
| (95% CI) | (45, 100) | (51, 87) | (49, 85) | (80, 100) | (0, 15) | (34, 82) | (26, 73) | (39, 82) |
| Mean change in haemoglobin concentration (g dl−1) (imputed analysis)b | ||||||||
| Mean | 1.45 | 1.66 | 2.07 | 2.91 | 0.00 | 1.18 | 1.22 | 1.70 |
| 95% CI | (−0.05,2.95) | (0.90,2.42) | (1.34,2.80) | (2.20, 3.62) | (−0.39,0.39) | (0.33,2.04) | (0.53,1.92) | (0.89,2.50) |
| Mean change in haemoglobin concentration (g dl−1) (alternate analysis)b | ||||||||
| n | 4 | 20 | 22 | 18 | 16 | 15 | 15 | 13 |
| Mean | 1.98 | 2.01 | 2.69 | 3.16 | 0.05 | 1.71 | 1.38 | 2.05 |
| 95% CI | (−0.8,4.75) | (0.85,3.18) | (1.83,3.55) | (2.49,3.84) | (−0.40,0.50) | (0.73,2.69) | (0.48,2.28) | (1.5,3.04) |
| Patients with RBC transfusion from week 5 to EOTP (subset analysis) | ||||||||
| n | 5 | 32 | 30 | 29 | 20 | 20 | 20 | 21 |
| Proportiona | 20 | 36 | 14 | 7 | 21 | 16 | 6 | 10 |
| (95% CI) | (0, 55) | (10, 62) | (1, 26) | (0, 17) | (3, 39) | (0, 33) | (0, 16) | (0, 23) |
a
Proportion calculated using K-M estimate.
b
Change from baseline calculated using last available haemoglobin value not within 28 days of a transfusion (imputed analysis), and for patients with haemoglobin value at week 13 not within 28 days of a transfusion (alternate analysis). QW=once weekly; Q3W=once every 3 weeks; Q4W=once every 4 weeks; N=number in cohort; CI=confidence interval; RBC=red blood cell; EOTP=end of treatment period; n=number in subset; NE=not estimable (median not reached).