Safety summary. (A) Treatment-emergent adverse events (SAF); (B) TEAEs for serious infections, herpes zoster-related disease and malignancies for overall study period (SAF)
| (A) | Weeks 0–12 | Overall period | |||||
| Placebo (N=170) | Peficitinib 100 mg (N=174) | Peficitinib 150 mg (N=174) | Peficitinib 100 mg +150 mg (N=348) | Peficitinib 100 mg (N=174) | Peficitinib 150 mg (N=174) | Peficitinib 100 mg +150 mg (N=348) | |
| AEs | 84 (49.4) | 89 (51.1) | 104 (59.8) | 193 (55.5) | 154 (88.5) | 153 (87.9) | 307 (88.2) |
| Drug-related AEs* | 47 (27.6) | 57 (32.8) | 80 (46.0) | 137 (39.4) | 118 (67.8) | 123 (70.7) | 241 (69.3) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SAEs | 4 (2.4) | 5 (2.9) | 3 (1.7) | 8 (2.3) | 19 (10.9) | 13 (7.5) | 32 (9.2) |
| Drug-related SAEs* | 2 (1.2) | 3 (1.7) | 3 (1.7) | 6 (1.7) | 10 (5.7) | 8 (4.6) | 18 (5.2) |
| ≥Grade 3 AEs† | 8 (4.7) | 9 (5.2) | 16 (9.2) | 25 (7.2) | 29 (16.7) | 32 (18.4) | 61 (17.5) |
| TEAEs leading to permanent discontinuation of study drug | |||||||
| All | 7 (4.1) | 5 (2.9) | 5 (2.9) | 10 (2.9) | 13 (7.5) | 12 (6.9) | 25 (7.2) |
| Drug-related AEs* | 6 (3.5) | 3 (1.7) | 5 (2.9) | 8 (2.3) | 7 (4.0) | 11 (6.3) | 18 (5.2) |
| SAEs | 3 (1.8) | 1 (0.6) | 0 | 1 (0.3) | 6 (3.4) | 4 (2.3) | 10 (2.9) |
| Drug-related SAEs* | 2 (1.2) | 1 (0.6) | 0 | 1 (0.3) | 4 (2.3) | 3 (1.7) | 7 (2.0) |
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 (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.
AE, adverse event; SAE, severe adverse event; SAF, safety analysis set; TEAE, treatment-emergent adverse event.