Table 3.

Number of reported adverse events and serious adverse events

	Sequential monotherapy	Step-up combination therapy	Initial combination with prednisone	Initial combination with infliximab	p Value
	N=40	N=45	N=56	N=43
0–1 year follow-up
AE, n*	31	51	41	34	0.414
SAE, n*	3	3	6	1	0.400
0–10 year follow-up
Total AE, n*	293	292	368	312	0.872
Patients with AE, n (%)	36	39	55	41	0.113
Total SAE, n*	50	33	60	43	0.183
Patients with SAE, n (%)	25 (63)	19 (42)	27 (48)	22 (51)	0.300
Patients with serious infection, n (%)	9 (23)	5 (11)	5 (9)	3 (7)	0.124
Patients with malignancy, n (%)	3 (8)	2 (4)	8 (14)	6 (14)	0.310
Deceased, n†	1	4	1	4	0.220

*More events per patient possible.

†Causes of death, group 1: 1 ischaemic colon after complicated diverticulitis surgery; group 2: 1 lung carcinoma, 1 stomach cancer, 2 unknown; group 3: 1 lung carcinoma; group 4: 1 oesophagus carcinoma, 1 cardiac arrest, 1 lung carcinoma, 1 unknown.

AE, adverse event; SAE, serious adverse event.