Table 4.

Frequency of observed and expected solid malignancy events and SIR.

Follow-up period (duration*)	SM etanercept group (E)				SM placebo group (P)				E vs P
	Observed (N)	Expected (N)	SIR	95% CI	Observed (N)	Expected (N)	SIR	95% CI	p†	p††
Trial (30 m)	6	1.58	3.80	1.39 – 8.26	0	1.02	0	0 – 3.63	0.01	0.03
Post-trial (43 m)	8	2.04	3.92	1.69–7.72	5	1.73	2.89	0.94 – 6.73	0.39	0.60
From trial entry (64 m)	14	3.73	3.76	2.05 – 6.31	5	2.92	1.71	0.56 – 3.99	0.03	0.12

^*Duration: median, in months

^†Comparison of frequencies of malignancies, Fisher exact test

^††Comparison of the SIRs, F-test

SM= solid malignancies

N=number of events

SIR=Standardized incidence ratio.