Table 2: Adverse events leading to premature discontinuation of study drug by treatment group.

FCM ()SMC ()

System organ classSystem organ class
 Adverse event (%) Adverse event (%)

General disorders and administration site conditionsGastrointestinal disorders
 Injection site extravasation5 (0.5) Constipation6 (0.6)
 Injection site bruising2 (0.2) Nausea6 (0.6)
Immune system disorders Abdominal pain5 (0.5)
 Hypersensitivity1 (0.1) Vomiting2 (0.2)
 Abdominal discomfort1 (0.1)
 Small intestinal obstruction1 (0.1)
 Abdominal hernia1 (0.1)
 Abdominal adhesions1 (0.1)
Reproductive system and breast disorders
 Uterine hemorrhage2 (0.2)
 Menorrhagia1 (0.1)
 Postpartum hemorrhage1 (0.1)
 Vulvovaginal pruritus1 (0.1)
 Drug exposure via breast milk1 (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.