Table 3.

Adverse events

		Step-up group (n=193)	Top-down group (n=193)
Any adverse event
Flare of Crohn's disease		225, 132 (68%)	30, 26 (13%)
Infection		20, 12 (6%)	23, 16 (8%)
Thiopurine intolerance		59, 48 (25%)	87, 62 (32%)
Methotrexate intolerance		9, 4 (2%)	8, 6 (3%)
Infliximab intolerance		0	8, 8 (4%)
Malignancy		0	0
Other		2, 2 (1%)	12, 8 (4%)
Serious adverse events
Hospitalisation for flare of Crohn's disease		15, 12 (6%)	3, 3 (2%)
Surgery for disease complication		11, 10 (5%)	2, 2 (1%)
	Abdominal surgery	10, 9 (5%)	1, 1 (1%)
	Perianal surgery	1, 1 (1%)	1, 1 (1%)
Medication related		1, 1 (1%)	1, 1 (1%)
Serious infection		8, 4 (2%)	3, 3 (2%)
Malignancy		0	0
Death		0	0
Other		7, 6 (3%)	6, 4 (2%)

Data are number of events, number of patients (%). Adverse events presented by biomarker status are shown in appendix 1 (p 16).