Table 3.

Treatment-emergent adverse events in Crohn’s disease and ulcerative colitis in the main and extension study, safety population

	Main study (week 0–52)				Extension study (week 52–78)
	Crohn’s disease		Ulcerative colitis		Crohn’s disease		Ulcerative colitis
	CT-P13 n = 77	IFX n = 78	CT-P13 n = 46	IFX n = 47	CT-P13 Maintenance n = 65	IFX/CT-P13 Switch n = 62	CT-P13 Maintenance n = 42	IFX/CT-P13 Switch n = 38
Overview
SUSAR	0	0	0	0	0	0	0	0
Serious adverse events	9/8 (10%)	9/8 (10%)	3/3 (7%)	4/4 (9%)	7/6 (9%)	4/3 (5%)	0	2/2 (5%)
Adverse events	130/57 (74%)	107/49 (63%)	65/29 (63%)	57/32 (68%)	42/24 (37%)	28/18 (29%)	17/12 (29%)	20/14 (37%)
Adverse events leading to study drug discontinuation	2 (2.6%)	1 (1.3%)	0 (0%)	2 (4.3%)	0 (0%)	1 (1.6%)	0 (0%)	0 (0%)
Most frequent treatment-emergent adverse events
Minor infections†	21/18 (23%)	16/15 (19%)	8/8 (17%)	4/4 (9%)	8/8 (12%)	3/3 (5%)	7/6 (14%)	8/8 (21%)
Iron deficiency	3/3 (4%)	2/2 (3%)	–	–	3/2 (3%)	2/1 (2%)	–	–
Infusion-related reaction	–	–	1/1 (2%)	2/2 (4%)	3/3 (5%)	–	–	–
Kidney stones	–	–	–	–	1/1 (2%)	2/1 (2%)	–	–
Nausea	–	–	–	–	1/1 (2%)	1/1 (2%)	–	–
Rash	5/5 (6%)	–	3/3 (7%)	4/4 (9%)	1/1 (2%)	3/3 (5%)	–	–
Back pain	–	–	–	–	–	–	1/1 (2%)	1/1 (3%)
Headache	1/1 (1%)	5/5 (6%)	1/1 (2%)	2/1 (2%)	–	–	–	–
Depression	1/1 (1%)	3/3 (4%)	–	–	–	–	–	–
Joint pain	1/1 (1%)	3/3 (4%)	–	–	–	–	–	–
Elevated liver enzymes	–	–	4/3 (7%)	1/1 (1%)	–	–	–	–
Cataract	–	–	1/1 (2%)	–	–	–	–	–
Amaurosis fugax	–	–	–	–	–	–	1/1 (2%)	–
Anaemia	–	–	–	–	–	–	–	1/1 (3%)

Data are number of events/number of patients (%)

IFX infliximab, SUSAR suspected unexpected serious adverse reaction

^†Minor infections: cold, otitis, sinusitis, flu, urinary tract infections, gastroenteritis, cholecystitis