Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia
Table 2
Adverse events leading to premature discontinuation of study drug by treatment group.
FCM ()
SMC ()
System organ class
System organ class
Adverse event
(%)
Adverse event
(%)
General disorders and administration site conditions
Gastrointestinal disorders
Injection site extravasation
5 (0.5)
Constipation
6 (0.6)
Injection site bruising
2 (0.2)
Nausea
6 (0.6)
Immune system disorders
Abdominal pain
5 (0.5)
Hypersensitivity
1 (0.1)
Vomiting
2 (0.2)
Abdominal discomfort
1 (0.1)
Small intestinal obstruction
1 (0.1)
Abdominal hernia
1 (0.1)
Abdominal adhesions
1 (0.1)
Reproductive system and breast disorders
Uterine hemorrhage
2 (0.2)
Menorrhagia
1 (0.1)
Postpartum hemorrhage
1 (0.1)
Vulvovaginal pruritus
1 (0.1)
Drug exposure via breast milk
1 (0.1)
FCM = ferric carboxymaltose; SMC = standard medical care. One subject had multiple adverse events leading to premature discontinuation of study drug. Six subjects had multiple adverse events leading to premature discontinuation of study drug.