Table 3.
Grade ≥ 3 AEs
| Dose received in preceding phase II trial | Total (N = 611) | |||||
|---|---|---|---|---|---|---|
| Placebo (n = 116) | Peficitinib 25 mg (n = 112) | Peficitinib 50 mg (n = 124) | Peficitinib 100 mg (n = 128) | Peficitinib 150 mg (n = 131) | ||
| RA | 1 (0.9) | 1 (0.9) | 2 (1.6) | 1 (0.8) | 0 | 5 (0.8) |
| Appendicitis | 1 (0.9) | 0 | 0 | 1 (0.8) | 1 (0.8) | 3 (0.5) |
| UTI | 0 | 0 | 0 | 2 (1.6) | 1 (0.8) | 3 (0.5) |
| Anaemia | 1 (0.9) | 0 | 0 | 2 (1.6) | 0 | 3 (0.5) |
| Headache | 0 | 1 (0.9) | 1 (0.8) | 1 (0.8) | 0 | 3 (0.5) |
| Pregnancya | 1 (0.9) | 0 | 1 (0.8) | 1 (0.8) | 0 | 3 (0.5) |
| Gastroenteritis | 0 | 0 | 1 (0.8) | 0 | 1 (0.8) | 2 (0.3) |
| Musculoskeletal pain | 0 | 0 | 0 | 1 (0.8) | 1 (0.8) | 2 (0.3) |
| Medical device complication | 0 | 0 | 1 (0.8) | 0 | 1 (0.8) | 2 (0.3) |
| Non-cardiac chest pain | 0 | 0 | 0 | 2 (1.6) | 0 | 2 (0.3) |
| Abdominal pain | 0 | 1 (0.9) | 0 | 1 (0.8) | 0 | 2 (0.3) |
| Nausea | 1 (0.9) | 0 | 0 | 1 (0.8) | 0 | 2 (0.3) |
| COPD | 1 (0.9) | 1 (0.9) | 0 | 0 | 0 | 2 (0.3) |
| Angina pectoris | 0 | 0 | 0 | 1 (0.8) | 1 (0.8) | 2 (0.3) |
| Cholelithiasis | 1 (0.9) | 0 | 1 (0.8) | 0 | 0 | 2 (0.3) |
| Blood CPK increase (> 1.5 × ULN) | 0 | 1 (0.9) | 0 | 0 | 1 (0.8) | 2 (0.3) |
All data are represented as n (%)
COPD chronic obstructive pulmonary disease, CPK creatine phosphokinase, RA rheumatoid arthritis, AE treatment-emergent adverse event, ULN upper limit of normal, UTI urinary tract infection
aOf the three patients who experienced a grade 3 AE of pregnancy during this study, one patient had an induced abortion and discontinued the study (previously received placebo in their respective preceding global phase II trial), and two patients had unknown pregnancy outcomes and discontinued the study (previously received peficitinib 50 mg and peficitinib 100 mg in their respective preceding global phase II trial)