Table 3. Most common all-causality treatment-emergent AEs occurring in ≥ 2% patients in any of the treatment groups.
| AE, n (%)* | Tofacitinib | |||||
|---|---|---|---|---|---|---|
| 1 mg BID (n = 53) | 3 mg BID (n = 53) | 5 mg BID (n = 52) | 10 mg BID (n = 53) | 15 mg BID (n = 54) | Placebo (n = 52) | |
| Nasopharyngitis | 6 (11.3) | 4 (7.5) | 6 (11.5) | 3 (5.7) | 8 (14.8) | 6 (11.5) |
| Hyperlipidemia | 1 (1.9) | 0 | 2 (3.8) | 6 (11.3) | 3 (5.6) | 0 |
| Headache | 1 (1.9) | 3 (5.7) | 2 (3.8) | 1 (1.9) | 0 | 1 (1.9) |
| LDL-C increased | 0 | 1 (1.9) | 0 | 1 (1.9) | 6 (11.1) | 0 |
| ALT increased | 0 | 2 (3.8) | 0 | 1 (1.9) | 1 (1.9) | 3 (5.8) |
| Constipation | 1 (1.9) | 0 | 1 (1.9) | 0 | 3 (5.6) | 2 (3.8) |
| Pharyngitis | 0 | 0 | 0 | 3 (5.7) | 2 (3.7) | 1 (1.9) |
| Stomatitis | 1 (1.9) | 1 (1.9) | 2 (3.8) | 1 (1.9) | 0 | 1 (1.9) |
| Abdominal discomfort | 2 (3.8) | 1 (1.9) | 0 | 1 (1.9) | 0 | 1 (1.9) |
| AST increased | 0 | 1 (1.9) | 0 | 1 (1.9) | 0 | 3 (5.8) |
| Blood cholesterol increased | 0 | 1 (1.9) | 1 (1.9) | 1 (1.9) | 2 (3.7) | 0 |
| Fall | 3 (5.7) | 0 | 1 (1.9) | 1 (1.9) | 0 | 0 |
| Herpes zoster | 0 | 0 | 1 (1.9) | 3 (5.7) | 1 (1.9) | 0 |
| Hypercholesterolemia | 0 | 2 (3.8) | 0 | 3 (5.7) | 0 | 0 |
| Bronchitis | 1 (1.9) | 1 (1.9) | 0 | 2 (3.8) | 0 | 0 |
| Contusion | 2 (3.8) | 1 (1.9) | 0 | 0 | 1 (1.9) | 0 |
| Dental caries | 0 | 0 | 2 (3.8) | 1 (1.9) | 0 | 1 (1.9) |
| Gingivitis | 0 | 1 (1.9) | 0 | 0 | 2 (3.7) | 1 (1.9) |
| Hypertension | 0 | 0 | 3 (5.8) | 1 (1.9) | 0 | 0 |
| Upper respiratory tract infection | 0 | 0 | 1 (1.9) | 3 (5.7) | 0 | 0 |
| Diarrhea | 1 (1.9) | 0 | 0 | 0 | 0 | 2 (3.8) |
| Gastritis | 0 | 1 (1.9) | 0 | 0 | 2 (3.7) | 0 |
| RA | 0 | 0 | 0 | 0 | 0 | 2 (3.8) |
| Upper respiratory tract inflammation | 0 | 0 | 0 | 0 | 0 | 2 (3.8) |
AE adverse event, ALT alanine transaminase, AST aspartate transaminase, BID twice daily, LDL-C low-density lipoprotein cholesterol.
*Preferred terms according to Medical Dictionary for Regulatory Activities version 13.0.