Table 3: Odds ratio of clinical failure in primary and secondary efficacy endpoints for intravenous FCM treatment.

CharacteristicHemoglobin increase ≥2 g/dLHemoglobin increase ≥3 g/dLTransferrin saturation >
(%)OR (95% CI) (%)OR (95% CI) (%)OR (95% CI)

All190 (41)94 (20)285 (63)
Male35 (35)1.7 (0.94–3.13)20 (20)1.01 (0.50–2.10)54 (55)1.45 (0.91–2.31)
Iron deficiency anemia184 (40)1.27 (0.42–3.45)92 (24)0.07 (0.010.24)53 (69)1.29 (0.77–2.23)
Iron deficiency without anemia53 (69)0.77 (0.45–1.30)
Diseases of the digestive system79 (40)0.88 (0.54–1.42)43 (22)0.57 (0.31–1.04)123 (63)0.95 (0.63–1.4)
Diseases of the genitourinary system67 (55)0.46 (0.250.87)31 (26)1.22 (0.59–2.54)82 (68)0.88 (0.52–1.48)
Neoplasms12 (26)2.19 (0.98–5.19)5 (11)1.63 (0.57–5.72)30 (67)0.70 (0.35–1.38)
Diseases of the circulatory system11 (29)3.34 (1.318.98)6 (16)2.1 (0.72–6.86)18 (47)1.82 (0.91–3.65)
Other diseases21 (40)0.94 (0.45–1.97)9 (17)1.12 (0.47–2.90)32 (62)1.13 (0.61–2.06)
Cumulative FCM treatment
 500 mg18 (15)5 (4)58 (51)
 501–1000 mg141 (49)0.34 (0.180.62)70 (24)0.36 (0.120.92)189 (65)0.57 (0.360.88)
 1001–3000 mg31 (66)0.19 (0.070.49)19 (40)0.23 (0.060.73)38 (81)0.25 (0.100.55)

Significant odds ratio in boldface; CI: confidence interval; FCM: ferric carboxymaltose; OR: odds ratio; N = 450, only patients who had transferrin saturation <20% before treatment were considered for this endpoint. Reference group: cumulative iron dose of 500 mg.