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 AE143 (23.6)129 (33.1)150 (24.1)125 (31.3)
Gastrointestinal disorders13 (2.1)21 (5.4)66 (10.6)71 (17.8)
 Constipation5 (0.8)4 (1.0)37 (5.9)42 (10.5)
 Diarrhea3 (0.5)6 (1.5)8 (1.3)12 (3.0)
 Nausea1 (0.2)7 (1.8)15 (2.4)20 (5.0)
 Vomiting1 (0.2)1 (0.3)5 (0.8)8 (2.0)
General disorders and administration site conditions43 (7.1)44 (11.3)1 (0.2)11 (2.8)
 Injection site extravasation12 (2.0)12 (3.1)00
 Injection site pain4 (0.7)8 (2.1)01 (0.3)
 Injection site bruising5 (0.8)6 (1.5)00
 Injection site irritation5 (0.8)3 (0.8)00
 Injection site paresthesia1 (0.2)5 (1.3)00
 Injection site coldness3 (0.5)2 (0.5)00
Immune system disorders3 (0.5)2 (0.5)00
Investigations20 (3.3)5 (1.3)10 (1.6)1 (0.3)
 ALT increased17 (2.8)1 (0.3)6 (1.0)0
 AST increased14 (2.3)08 (1.3)0
Metabolism and nutrition disorders1 (0.2)7 (1.8)1 (0.2)0
 Hypophosphatemia06 (1.5)00
Nervous system disorders21 (3.5)28 (7.2)12 (1.9)9 (2.3)
 Dizziness09 (2.3)03 (0.8)
 Headache12 (2.0)13 (3.3)9 (1.4)6 (1.5)
 Dysgeusia4 (0.7)3 (0.8)00

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.