Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia
Table 4
Treatment-emergent adverse events occurring in ≥2% of subjects in either treatment group or with a statistically significant difference between the FCM or SMC treatment groups by anemia etiology (safety population).
System organ class Preferred term
FCM
SMC
Postpartum () (%)
HMB () (%)
Postpartum () (%)
HMB () (%)
≥1 treatment-emergent AE
143 (23.6)
129 (33.1)
150 (24.1)
125 (31.3)
Gastrointestinal disorders
13 (2.1)
21 (5.4)
66 (10.6)
71 (17.8)
Constipation
5 (0.8)
4 (1.0)
37 (5.9)
42 (10.5)
Diarrhea
3 (0.5)
6 (1.5)
8 (1.3)
12 (3.0)
Nausea
1 (0.2)
7 (1.8)
15 (2.4)
20 (5.0)
Vomiting
1 (0.2)
1 (0.3)
5 (0.8)
8 (2.0)
General disorders and administration site conditions
43 (7.1)
44 (11.3)
1 (0.2)
11 (2.8)
Injection site extravasation
12 (2.0)
12 (3.1)
0
0
Injection site pain
4 (0.7)
8 (2.1)
0
1 (0.3)
Injection site bruising
5 (0.8)
6 (1.5)
0
0
Injection site irritation
5 (0.8)
3 (0.8)
0
0
Injection site paresthesia
1 (0.2)
5 (1.3)
0
0
Injection site coldness
3 (0.5)
2 (0.5)
0
0
Immune system disorders
3 (0.5)
2 (0.5)
0
0
Investigations
20 (3.3)
5 (1.3)
10 (1.6)
1 (0.3)
ALT increased
17 (2.8)
1 (0.3)
6 (1.0)
0
AST increased
14 (2.3)
0
8 (1.3)
0
Metabolism and nutrition disorders
1 (0.2)
7 (1.8)
1 (0.2)
0
Hypophosphatemia
0
6 (1.5)
0
0
Nervous system disorders
21 (3.5)
28 (7.2)
12 (1.9)
9 (2.3)
Dizziness
0
9 (2.3)
0
3 (0.8)
Headache
12 (2.0)
13 (3.3)
9 (1.4)
6 (1.5)
Dysgeusia
4 (0.7)
3 (0.8)
0
0
AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; FCM = ferric carboxymaltose; HMB = heavy menstrual bleeding; SMC = standard medical care. All comparisons between the FCM and SMC groups are statistically significant () unless otherwise noted. Each subject is counted only once per system organ class. Not statistically significant from the FCM group.
