Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia
Table 3
Treatment-emergent adverse events occurring in ≥2% of subjects either in treatment group or with a statistically significant difference between the FCM and SCM treatment groups (safety population).
System organ class Preferred term
FCM () (%)
SMC () (%)
≥1 treatment-emergent AE
272 (27.3%)
275 (26.9)
Gastrointestinal disorders
34 (3.4)
137 (13.4)
Constipation
9 (0.9)
79 (7.7)
Diarrhea
9 (0.9)
20 (2.0)
Nausea
8 (0.8)
35 (3.4)
Vomiting
2 (0.2)
13 (1.3)
General disorders and administration site conditions
87 (8.7)
12 (1.2)
Injection site extravasation
24 (2.4)
0
Injection site pain
12 (1.2)
1 (0.1)
Injection site bruising
11 (1.1)
0
Injection site irritation
8 (0.8)
0
Injection site paresthesia
6 (0.6)
0
Injection site coldness
5 (0.5)
0
Immune system disorders
5 (0.5)
0
Investigations
25 (2.5)
11 (1.1)
ALT increased
18 (1.8)
6 (0.6)
Metabolism and nutrition disorders
8 (0.8)
1 (0.1)
Hypophosphatemia
6 (0.6)
0
Nervous system disorders
49 (4.9)
21 (2.1)
Headache
25 (2.5)
15 (1.5)
Dysgeusia
7 (0.7)
0
AE = adverse event; ALT = alanine aminotransferase; FCM = ferric carboxymaltose; 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.
