Table 2.

Baseline and follow-up hemoglobin and indices of iron stores, intent-to-treat population^a

Parameter	Ferumoxytol (n = 228)	Oral Iron (n = 76)	Pb
Hemoglobin (g/dl; mean ± SD)
baselinec	9.96 ± 0.69	9.96 ± 0.78
day 21	10.71 ± 1.03	10.21 ± 0.80
day 35	10.88 ± 1.27	10.15 ± 1.07
day 35 change from baselined	0.82 ± 1.24	0.16 ± 1.02	<0.0001
Hemoglobin ≥1-g/dl increase from baseline (%)
day 21	32.5	15.8
day 35	39.0	18.4	0.0010
Ferritin (ng/ml; mean ± SD)
baselinec	146.1 ± 173.6	143.5 ± 144.9
day 21	703.1 ± 355.6	157.6 ± 154.5
day 35	555.7 ± 320.0	160.8 ± 161.0
day 35 change from baseline	381.7 ± 278.6	6.9 ± 60.1	<0.0001
Serum iron (μg/dl; mean ± SD)
baselinec	45.0 ± 18.2	43.7 ± 18.6
day 21	76.5 ± 35.8	52.7 ± 25.2
day 35	68.0 ± 26.2	50.1 ± 19.1
day 35 change from baselined	22.7 ± 24.3	4.4 ± 19.2	<0.0001
TSAT (%; mean ± SD)
baselinec	11.3 ± 6.1	10.1 ± 5.5
day 21	24.1 ± 13.1	12.8 ± 8.1
day 35	21.0 ± 10.1	11.8 ± 6.7
day 35 change from baselined	9.8 ± 9.2	1.3 ± 6.4	<0.0001

^aTo convert to SI units, multiply hemoglobin by 10 to obtain g/dl, ferritin by 1 to obtain μg/L, and iron by 0.179 to obtain μmol/L.

^bTwo-sample t test for evaluating a difference between the treatment groups in change from baseline.

^cBaseline value is the mean from the day −10 and day −5 values.

^dChange from baseline does not equal day 35 minus baseline because it includes imputed value of zero for change from baseline for patients who did not have a value obtained at day 35.