Overview of TEAEs
| Placebo (N=56) | Peficitinib 25 mg (N=55) | Peficitinib 50 mg (N=57) | Peficitinib 100 mg (N=55) | Peficitinib 150 mg (N=58) | Peficitinib total (N=225) | |
|---|---|---|---|---|---|---|
| Any TEAEs | 36 (64.3%) | 39 (70.9%) | 37 (64.9%) | 29 (52.7%) | 39 (67.2%) | 144 (64.0%) |
| ≥Grade 3 TEAEs* | 3 (5.4%) | 4 (7.3%) | 3 (5.3%) | 6 (10.9%) | 2 (3.4%) | 15 (6.7%) |
| Serious TEAEs | 1 (1.8%) | 1 (1.8%) | 2 (3.5%) | 3 (5.5%) | 0 | 6 (2.7%) |
| Deaths | 0 | 0 | 1 (1.8%) | 0 | 0 | 1 (0.4%) |
| TEAEs leading to discontinuation | 10 (17.9%) | 7 (12.7%) | 5 (8.8%) | 6 (10.9%) | 4 (6.9%) | 22 (9.8%) |
| Infections and infestations | 12 (21.4%) | 18 (32.7%) | 14 (24.6%) | 7 (12.7%) | 17 (29.3%) | 56 (24.9%) |
| GI disorders | 3 (5.4%) | 8 (14.5%) | 11 (19.3%) | 6 (10.9%) | 10 (17.2%) | 35 (15.6%) |
Data are expressed as number of patients (%).
*Based on NCI-CTCAE grade; grade 3=severe or medically significant, grade 4=life threatening, grade 5=death related to adverse event.
GI disorders, gastrointestinal disorders; TEAE, treatment-emergent adverse event.