Table 2B.

Incidence of serious infections, herpes zoster-related disease and malignancy per 100 patient-years, from week 0 to week 52 (SAF)

	Placebo (N=101)	Peficitinib 100 mg (N=104)	Peficitinib 150 mg (N=102)	Peficitinib 100 mg + 150 mg (N=206)	Peficitinib total* (N=296)	Etanercept (open-label arm) (N=200)
Serious infections
Patient-years	22.6	88.2	92.1	180.3	245.7	195.5
Number of patients who had at least one incidence	0	1	2	3	5	4
Incidence rate/100 patient-years (95% CI)	0.0	1.1 (0.2 to 8.1)	2.2 (0.5 to 8.7)	1.7 (0.5 to 5.2)	2.0 (0.8 to 4.9)	2.0 (0.8 to 5.5)
Herpes zoster-related disease (including varicella)
Patient-years	22.6	86.8	90.9	177.7	241.2	194.0
Number of patients who had at least one incidence	0	5	4	9	14	5
Incidence rate/100 patient-years (95% CI)	0.0	5.8 (2.4 to 13.8)	4.4 (1.7 to 11.7)	5.1 (2.6 to 9.7)	5.8 (3.4 to 9.8)	2.6 (1.1 to 6.2)
Malignancies
Patient-years	22.6	88.1	92.8	180.9	246.4	197.3
Number of patients who had at least one incidence	0	2	0	2	3	1
Incidence rate/100 patient-years (95% CI)	0.0	2.3 (0.6 to 9.1)	0.0 (- to -)	1.1 (0.3 to 4.4)	1.2 (0.4 to 3.8)	0.5 (0.1 to 3.6)

Patient-years was calculated from initial dose up to first incidence of the event for patients who had at least one event, and from initial dose through follow-up for patients who had no events; incidence rate is calculated as (100 × number of patients who had at least one incidence/total patient-years).

*Included adverse events occurring during treatment with peficitinib in patients who were initially treated with placebo and switched to peficitinib at week 12.

SAF, safety analysis set.