Table 2A.

TEAEs for weeks 0 to 12 and overall period (SAF)

	Weeks 0 to 12					Overall period
	Placebo (N=101)	Peficitinib 100 mg (N=104)	Peficitinib 150 mg (N=102)	Peficitinib 100 mg + 150 mg (N=206)	Etanercept (open-label arm) (N=200)	Peficitinib 100 mg (N=104)	Peficitinib 150 mg (N=102)	Peficitinib 100 mg + 150 mg (N=206)	Etanercept (open-label arm) (N=200)
All TEAEs	54 (53.5)	59 (56.7)	55 (53.9)	114 (55.3)	119 (59.5)	92 (88.5)	89 (87.3)	181 (87.9)	178 (89.0)
Drug-related TEAEs*	29 (28.7)	33 (31.7)	38 (37.3)	71 (34.5)	75 (37.5)	63 (60.6)	63 (61.8)	126 (61.2)	122 (61.0)
SAEs	4 (4.0)	3 (2.9)	2 (2.0)	5 (2.4)	4 (2.0)	7 (6.7)	8 (7.8)	15 (7.3)	18 (9.0)
Drug-related SAEs*	3 (3.0)	2 (1.9)	1 (1.0)	3 (1.5)	4 (2.0)	3 (2.9)	3 (2.9)	6 (2.9)	9 (4.5)
≥Grade 3 TEAE†	8 (7.9)	6 (5.8)	3 (2.9)	9 (4.4)	6 (3.0)	14 (13.5)	19 (18.6)	33 (16.0)	29 (14.5)
TEAEs leading to permanent discontinuation of study drug or reference drug
All	4 (4.0)	6 (5.8)	3 (2.9)	9 (4.4)	5 (2.5)	13 (12.5)	6 (5.9)	19 (9.2)	13 (6.5)
Drug-related*	1 (1.0)	4 (3.8)	2 (2.0)	6 (2.9)	5 (2.5)	7 (6.7)	4 (3.9)	11 (5.3)	11 (5.5)
SAEs	2 (2.0)	2 (1.9)	2 (2.0)	4 (1.9)	2 (1.0)	6 (5.8)	2 (2.0)	8 (3.9)	5 (2.5)
Drug-related SAEs*	1 (1.0)	1 (1.0)	1 (1.0)	2 (1.0)	2 (1.0)	3 (2.9)	1 (1.0)	4 (1.9)	4 (2.0)

Treatment-emergent adverse events are defined as any adverse event that started or worsened in severity after initial dose of study drug or reference drug through the follow-up period. All values are n (%).

*Possible or probable, as assessed by the investigator or records where relationship is missing.

†Based on National Cancer Institute Common Terminology Criteria for Adverse Events grading: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.

AE, adverse event; SAE, serious adverse event; SAF, safety analysis set; TEAE, treatment-emergent adverse event.