Anemia

Anemia / 2012 / Article / Tab 1

Clinical Study

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 studySingle-dose study
FCMSMCFCMSMC
( )( )( )( )

Age (years)
Sex
 Female292 (85.1)318 (88.3)322 (88.0)315 (85.4)
 Male51 (14.9)42 (11.7)44 (12.0)54 (14.6)
Race/Ethnicity
 Caucasian185 (53.9)180 (50.0)171 (46.7)205 (55.6)
 African American87 (25.4)113 (31.4)114 (31.1)96 (26.0)
 Hispanic58 (16.9)61 (16.9)70 (19.1)48 (13.0)
 Asian3 (0.9)1 (0.3)6 (1.6)10 (2.7)
 Other10 (2.9)5 (1.4)5 (1.4)10 (2.7)
Weight (kg)
IDA Etiology
 CKD40 (11.7)34 (9.4)67 (18.3)53 (14.4)
 Uterine bleeding77 (22.4)103 (28.6)61 (16.7)79 (21.4)
 GI related69 (20.1)66 (18.3)49 (13.4)47 (12.7)
 Postpartum35 (10.2)36 (10.0)56 (15.3)49 (13.3)
 Other/Unknown122 (35.6)121 (33.6)133 (36.3)141 (38.2)
Hb (g/dL)
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)
 ≥9.6194 (56.6)202 (56.1)286 (78.1)293 (79.4)
TSAT (%)
Ferritin (ng/mL)
No Current ESA use337 (98.3)356 (99.9)347 (94.8)351 (95.1)
No Iron Intolerance283 (82.5)302 (83.9)333 (91.0)318 (86.2)
Previous Iron Therapy242 (70.6)263 (73.1)241 (65.8)256 (69.4)
 Response: Poor/No208 (60.6)217 (60.3)246 (67.2)248 (67.2)
No imm.supp. therapy340 (99.1)353 (98)357 (97.5)357 (96.7)
Cardiovascular risk
 ≤2201 (58.6)222 (61.7)217 (59.3)230 (62.3)
 >2142 (41.4)138 (38.3)149 (40.7)139 (37.7)
Type of SMC NANA
 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 treatment20 (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.

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