Safety and Efficacy of Intravenous Ferric Carboxymaltose (750 mg) in the Treatment of Iron Deficiency Anemia: Two Randomized, Controlled Trials

Table 1

Demographics and baseline characteristics of subjects (safety population).

	Multidose study		Single-dose study
	FCM	SMC	FCM	SMC
	(𝑁=343)	(𝑁=360)	(𝑁=366)	(𝑁=369)
Age (years)	49.3±18.5	47.7±17.6	49.2±19.9	49.6±19.9
Sex
Female	292 (85.1)	318 (88.3)	322 (88.0)	315 (85.4)
Male	51 (14.9)	42 (11.7)	44 (12.0)	54 (14.6)
Race/Ethnicity
Caucasian	185 (53.9)	180 (50.0)	171 (46.7)	205 (55.6)
African American	87 (25.4)	113 (31.4)	114 (31.1)	96 (26.0)
Hispanic	58 (16.9)	61 (16.9)	70 (19.1)	48 (13.0)
Asian	3 (0.9)	1 (0.3)	6 (1.6)	10 (2.7)
Other	10 (2.9)	5 (1.4)	5 (1.4)	10 (2.7)
Weight (kg)	82.2±22.4	85.4±22.0	83.2±24.3	82.2±22.9
IDA Etiology
CKD	40 (11.7)	34 (9.4)	67 (18.3)	53 (14.4)
Uterine bleeding	77 (22.4)	103 (28.6)	61 (16.7)	79 (21.4)
GI related	69 (20.1)	66 (18.3)	49 (13.4)	47 (12.7)
Postpartum	35 (10.2)	36 (10.0)	56 (15.3)	49 (13.3)
Other/Unknown	122 (35.6)	121 (33.6)	133 (36.3)	141 (38.2)
Hb (g/dL)	9.6±1.1	9.6±1.1	10.8±1.1	10.8±1.0
Hb Category (g/dL)
≤8.0	40 (11.7)	46 (12.8)	9 (2.5)	5 (1.4)
8.1–9.5	109 (31.8)	112 (31.1)	71 (19.4)	71 (19.2)
≥9.6	194 (56.6)	202 (56.1)	286 (78.1)	293 (79.4)
TSAT (%)	10.6±7.9	10.5±8.0	15.9±9.2	15.0±8.4
Ferritin (ng/mL)	25.6±48.3	27.3±66.4	38.1±53.4	34.0±51.1
No Current ESA use	337 (98.3)	356 (99.9)	347 (94.8)	351 (95.1)
No Iron Intolerance	283 (82.5)	302 (83.9)	333 (91.0)	318 (86.2)
Previous Iron Therapy	242 (70.6)	263 (73.1)	241 (65.8)	256 (69.4)
Response: Poor/No	208 (60.6)	217 (60.3)	246 (67.2)	248 (67.2)
No imm.supp. therapy	340 (99.1)	353 (98)	357 (97.5)	357 (96.7)
Cardiovascular risk
≤2	201 (58.6)	222 (61.7)	217 (59.3)	230 (62.3)
>2	142 (41.4)	138 (38.3)	149 (40.7)	139 (37.7)
Type of SMC	NA		NA
Oral Iron		187 (51.9)		210 (56.9)
IV Iron		154 (42.8)		128 (34.7)
Venofer		112 (31.1)		69 (18.7)
Iron Dextran		33 (9.2)		56 (15.2)
Ferrlecit		9 (2.5)		3 (0.8)
Other or no treatment		20 (5.6)		30 (4.6)

Values are expressed as mean ± standard deviation or number (percentage).
CKD: chronic kidney disease; ESA: erythropoiesis-stimulating agent; FCM: ferric carboxymaltose; Hb: hemoglobin; IDA: iron deficiency anemia; IV: intravenous; NA: not applicable; SMC: standard medical care; TSAT: transferring saturation.