Table 3 Summary of adverse events during the placebo-controlled phase of the study through week 16 (before early escape)

Assessment	Group 1	Group 2	Golimumab + methotrexate
	Group 1	Group 2	Group 3	Group 4	Groups 3 and 4 combined
	Placebo + methotrexate	Golimumab 100 mg + placebo	50 mg	100 mg
Patients treated	133	133	89	89	178
Average duration of follow-up (weeks)	15.9	16.0	16.1	15.9	16.0
Average exposure (no of administrations)	3.9	4.0	3.9	3.9	3.9
Patients with one or more adverse events	81 (60.9%)	84 (63.2%)	61 (68.5%)	62 (69.7%)	123 (69.1%)
Patients with one or more serious adverse event	3 (2.3%)	5 (3.8%)	5 (5.6%)	8 (9.0%)	13 (7.3%)
Patients with one or more infection	32 (24.1%)	40 (30.1%)	25 (28.1%)	25 (28.1%)	50 (28.1%)
Patients with one or more serious infections	1 (0.8%)	1 (0.8%)	2 (2.2%)	5 (5.6%)	7 (3.9%)
Patients with one or more injection-site disorders	3 (2.3%)	4 (3.0%)	4 (4.5%)	4 (4.5%)	8 (4.5%)
Patients with one or more malignancies	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.1%)	1 (1.1%)