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 AE272 (27.3%)275 (26.9)
Gastrointestinal disorders34 (3.4)137 (13.4)
 Constipation9 (0.9)79 (7.7)
 Diarrhea9 (0.9)20 (2.0)
 Nausea8 (0.8)35 (3.4)
 Vomiting2 (0.2)13 (1.3)
General disorders and administration site conditions87 (8.7)12 (1.2)
 Injection site extravasation24 (2.4)0
 Injection site pain12 (1.2)1 (0.1)
 Injection site bruising11 (1.1)0
 Injection site irritation8 (0.8)0
 Injection site paresthesia6 (0.6)0
 Injection site coldness5 (0.5)0
Immune system disorders5 (0.5)0
Investigations25 (2.5)11 (1.1)
 ALT increased18 (1.8)6 (0.6)
Metabolism and nutrition disorders8 (0.8)1 (0.1)
 Hypophosphatemia6 (0.6)0
Nervous system disorders49 (4.9)21 (2.1)
 Headache25 (2.5)15 (1.5)
 Dysgeusia7 (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.