Table 4.
Treatment-emergent adverse events occurring in ≥2% of subjects in either treatment group or with a statistically significant differencea between the FCM or SMC treatment groups by anemia etiology (safety population).
| System organ classb Preferred term |
FCM | SMC | ||
|---|---|---|---|---|
| Postpartum (n = 606) n (%) |
HMB (n = 390) n (%) |
Postpartum (n = 623) n (%) |
HMB (n = 399) n (%) |
|
| ≥1 treatment-emergent AE | 143 (23.6) | 129 (33.1) | 150 (24.1) c | 125 (31.3) c |
| 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)c |
| 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)c | 1 (0.3) |
| ALT increased | 17 (2.8) | 1 (0.3) | 6 (1.0) | 0 |
| AST increased | 14 (2.3) | 0 | 8 (1.3)c | 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)c | 9 (2.3) |
| Dizziness | 0 | 9 (2.3) | 0 | 3 (0.8)c |
| Headache | 12 (2.0) | 13 (3.3) | 9 (1.4)c | 6 (1.5)c |
| 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.
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.