Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial

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 analysis^a	323	334
KM% (95% CI)	76 (70, 81)	71 (66, 77)
Average Hb after achieving Hb ≥11 g/dL
Patients included in the analysis^b	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

ISSN: 1471-2407