Table 2.

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

FCM (n = 996)		SMC (n = 1022)
System organ class		System organ class
Adverse event	n a (%)	Adverse event	n b (%)
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.

^aOne subject had multiple adverse events leading to premature discontinuation of study drug.

^bSix subjects had multiple adverse events leading to premature discontinuation of study drug.