Table 5

Number of patients with one or more malignancies through week 160 compared with the expected number of malignancies from the general US population according to the SEER database

		Golimumab^†
	Placebo^*	50 mg	100 mg	Combined
Treated patients in the study^‡^§	155	279	328	431
Type of malignancy^¶
Lymphoma
Patient-years of follow-up
Total	58	302	560	863
Median	0.3	0.8	1.7	2.4
Observed/expected^** number of patients with event	0/0.02	0/0.11	4/0.20	4/0.30
SIR^†† (95% CI^‡‡)	0.00 (0.00 to 149.04)	0.00 (0.00 to 28.04)	20.37 (5.55 to 52.15)	13.19 (3.59 to 33.78)
Other malignancies
Patient-years of follow-up
Total	57	302	560	863
Median	0.3	0.8	1.7	2.4
Observed/expected^** number of patients with event	1/0.45	2/2.44	2/4.40	4/6.84
SIR^†† (95% CI^‡‡)	2.24 (0.06 to 12.50)	0.82 (0.10 to 2.96)	0.45 (0.06 to 1.64)	0.58 (0.16 to 1.50)
All malignancies
Patient-years of follow-up
Total	57	302	560	862
Median	0.3	0.8	1.7	2.4
Observed/expected^** number of patients with event	1/0.46	2/2.54	6/4.58	8/7.12
SIR^†† (95% CI^‡‡)	2.15 (0.05 to 12.00)	0.79 (0.10 to 2.84)	1.31 (0.48 to 2.85)	1.12 (0.49 to 2.21)

↵* Received placebo with or without MTX.
↵† Received golimumab with or without MTX. Subcutaneous injections were administered every 4 weeks.
↵‡ Patients may appear in more than one column.
↵§ Through 12 August 2009.
↵¶ Includes patients with malignancies (excluding nonmelanoma skin cancers, which are not included in the SEER database) during the study.
↵** The expected number of patients with malignancies is based on the SEER database,¹³ adjusted for age, gender and race.
↵†† SIR is the observed number of patients with malignancy divided by expected number of patients with malignancy.
↵‡‡ CI based on an exact method.
MTX, methotrexate; SEER, Surveillance, Epidemiology and End Results (database); SIR, standardised incidence ratio.