Table 2A

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

Weeks 0 to 12Overall 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 TEAEs54 (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)
SAEs4 (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
 All4 (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)
 SAEs2 (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.