Table 3.
Secondary efficacy endpoints
| QW | EDS | |
|---|---|---|
| (n = 374) | (n = 378) | |
| Patients who achieved Hb ≥11 g/dL from baseline to Week 13 | ||
| Patients included in the analysisa | 323 | 334 |
| KM% (95% CI) | 76 (70, 81) | 71 (66, 77) |
| Average Hb after achieving Hb ≥11 g/dL | ||
| Patients included in the analysisb | 301 | 304 |
| Mean (95% CI) | 11.6 (11.5, 11.7) | 11.8 (11.7, 11.9) |
| Category - % | ||
| <11 g/dL | 22 | 13 |
| 11 to 13 g/dL | 74 | 84 |
| >13 g/dL | 4 | 4 |
| Patients who had a hematopoietic response from baseline to Week 13 | ||
| Patients included in the analysis | 374 | 378 |
| KM% (95% CI) | 59 (53, 64) | 53 (48,59) |
| Patients who had a hematopoietic response from baseline to end of treatment | ||
| Patients included in the analysis | 374 | 378 |
| KM% (95% CI) | 86 (82, 91) | 84 (79, 88) |
| Patients who had an RBC transfusion from baseline to Week 13 | ||
| Patients included in the analysis | 374 | 378 |
| KM% (95% CI) | 25 (20, 29) | 20 (16, 24) |
| Patients who had an RBC transfusion from baseline to end of treatment | ||
| Patients included in the analysis | 374 | 378 |
| KM% (95% CI) | 29 (24, 34) | 26 (21, 30) |
aPatients who had Hb values ≤11 g/dL at baseline were included in the analysis
bPatients who achieved Hb ≥11 g/dL or who had Hb values ≥11 g/dL at baseline were included in the analysis
QW = once weekly; EDS = extended dosing schedule; Hb = Hemoglobin; CI = confidence interval; KM = Kaplan-Meier