Table 3.
Treatment-emergent adverse events occurring in ≥2% of subjects either in treatment group or with a statistically significanta difference between the FCM and SCM treatment groups (safety population).
| System organ classb Preferred term |
FCM (n = 996) n (%) |
SMC (n = 1022) n (%) |
|---|---|---|
| ≥1 treatment-emergent AE | 272 (27.3%) | 275 (26.9) c |
| Gastrointestinal disorders | 34 (3.4) | 137 (13.4) |
| Constipation | 9 (0.9) | 79 (7.7) |
| Diarrhea | 9 (0.9) | 20 (2.0)c |
| 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)c |
| Dysgeusia | 7 (0.7) | 0 |
AE = adverse event; ALT = alanine aminotransferase; FCM = ferric carboxymaltose; SMC = standard medical care.
aAll comparisons between the FCM and SMC groups are statistically significant (P ≤ 0.05) unless otherwise noted.
bEach subject is counted only once per system organ class.
cNot statistically significant from the FCM group.