Direct Comparison of the Safety and Efficacy of Ferric Carboxymaltose versus Iron Dextran in Patients with Iron Deficiency Anemia
Table 2
Treatment-emergent adverse events experienced by ≥5% of patients in either FCM or DEX group.
MedDRA SOCa Preferred term
FCM () (%)
DEX () (%)
valueb
At Least 1 treatment-emergent adverse event
60 (73.2%)
59 (75.6%)
0.856
Gastrointestinal disorders
24 (29.3%)
14 (17.9%)
0.099
Diarrhea
5 (6.1%)
3 (3.8%)
0.720
Nausea
12 (14.6%)
8 (10.3%)
0.477
Vomiting
5 (6.1%)
4 (5.1%)
1.000
Immune system disorders
0
8 (10.3%)
0.003†
Hypersensitivity
0
7 (9.0%)
0.006†
Metabolism and nutrition disorders
8 (9.8%)
4 (5.1%)
0.371
Hypophosphatemia
7 (8.5%)
0
0.014*
Nervous system disorders
16 (19.5%)
17 (21.8%)
0.845
Dizziness
6 (7.3%)
4 (5.1%)
0.747
Headache
6 (7.3%)
10 (12.8%)
0.297
Skin and subcutaneous tissue disorders
6 (7.3%)
19 (24.4%)
0.004†
Pruritus
2 (2.4%)
6 (7.7%)
0.160
Rash
2 (2.4%)
5 (6.4%)
0.268
Urticaria
0
7 (9.0%)
0.006†
MedDRA: medical dictionary for regulatory activities; SOC: system organ class.
aEach subject is counted only once per SOC when multiple preferred terms are reported for the SOC.
bFrom Fisher’s exact test.
*Statistically significant at the level. †Statistically significant at the level.
