Table 3.

Adverse events experienced by ≥ 2% of subjects in either treatment group (safety population)

MedDRA SOC-preferred term, n (%)	FCM (n = 147)	Oral iron (n = 103)	P-value
≥ 1 adverse event	64 (43.5)	61 (59.2)	0.02
Gastrointestinal disorders	12 (8.2)	40 (38.8)
Constipation	2 (1.4)	18 (17.5)	< 0.001
Diarrhoea	2 (1.4)	4 (3.9)	0.23
Faeces discoloured	0 (0.0)	3 (2.9)	0.07
Gastrointestinal haemorrhage	0 (0.0)	3 (2.9)	0.07
Nausea	2 (1.4)	5 (4.9)	0.13
General disorders and administration site conditions	18 (12.2)	6 (5.8)
Infusion site reactions	3 (2.0)	0	0.27
Oedema peripheral	9 (6.1)	2 (1.9)	0.13
Infections and infestations	20 (13.6)	8 (7.8)
Bronchitis	3 (2.0)	0	0.27
Upper respiratory tract infection	2 (1.4)	4 (3.9)	0.23
Urinary tract infection	5 (3.4)	1 (1.0)	0.41
Metabolism and nutrition disorders	10 (6.8)	3 (2.9)
Hyperkalaemia	6 (4.1)	1 (1.0)	0.25
Nervous system disorders	6 (4.1)	7 (6.8)
Headache	3 (2.0)	2 (1.9)	1.00
Vascular disorders	9 (6.1)	2 (1.9)
Hypotension	3 (2.0)	0	0.08

FCM, ferric carboxymaltose; MedDRA, Medical Dictionary for Regulatory Activities; SOC, System Organ Class.