Common adverse events (AE) reported in ≥ 5% of all patients and AE of interest. Data reported as n (%).
| Placebo | 30 mg IR | 60 mg IR | 100 mg ER | All Patients | |
|---|---|---|---|---|---|
| During the initial 13 weeks of the study | n = 76 | n = 74 | n = 73 | n = 78 | n = 301 |
| Patients with AE | 57 (75.0) | 63 (85.1) | 60 (82.2) | 60 (76.9) | 240 (79.7) |
| Common AE | |||||
| Upper respiratory tract infection | 20 (26.3) | 6 (8.1) | 17 (23.3) | 7 (9.0) | 50 (16.6) |
| Nausea | 6 (7.9) | 3 (4.1) | 7 (9.6) | 7 (9.0) | 23 (7.6) |
| Rheumatoid arthritis* | 1 (1.3) | 9 (12.2) | 4 (5.5) | 9 (11.5) | 23 (7.6) |
| Urinary tract infection | 4 (5.3) | 6 (8.1) | 3 (4.1) | 5 (6.4) | 18 (6.0) |
| Rash | 2 (2.6) | 7 (9.5) | 4 (5.5) | 4 (5.1) | 17 (5.6) |
| Arthralgia | 0 | 6 (8.1) | 4 (5.5) | 6 (7.7) | 16 (5.3) |
| Diarrhea | 5 (6.6) | 4 (5.4) | 4 (5.5) | 3 (3.8) | 16 (5.3) |
| Dizziness | 2 (2.6) | 3 (4.1) | 4 (5.5) | 7 (9.0) | 16 (5.3) |
| Patients with any rash | 3 (3.9) | 10 (13.5) | 13 (17.8) | 8 (10.3) | 34 (11.3) |
| Localized | 2 (2.6) | 5 (6.8) | 4 (5.5) | 2 (2.6) | 13 (4.3) |
| Acne | 0 | 3 (4.1) | 5 (6.8) | 2 (2.6) | 10 (3.3) |
| Generalized | 1 (1.3) | 2 (2.7) | 5 (6.8) | 2 (2.6) | 10 (3.3) |
| No information available | 0 | 0 | 0 | 2 (2.6) | 2 (0.7) |
| During 26 weeks (including data during initial 13 weeks) | n = 76 | n = 158† | n = 106† | n = 78 | n = 301 |
| Patients with AE | 59 (77.6) | 126 (79.7) | 93 (87.7) | 61 (78.2) | 261 (86.7) |
| Common AE | |||||
| Upper respiratory tract infection | 22 (28.9) | 12 (7.6) | 25 (23.6) | 10 (12.8) | 67 (22.3) |
| Rheumatoid arthritis* | 6 (7.9) | 25 (15.8) | 17 (16.0) | 13 (16.7) | 57 (18.9) |
| Nausea | 7 (9.2) | 7 (4.4) | 14 (13.2) | 7 (9.0) | 34 (11.3) |
| Urinary tract infection | 5 (6.6) | 14 (8.9) | 9 (8.5) | 6 (7.7) | 29 (9.6) |
| Rash | 2 (2.6) | 11 (7.0) | 9 (8.5) | 5 (6.4) | 26 (8.6) |
| Arthralgia | 1 (1.3) | 10 (6.3) | 9 (8.5) | 7 (9.0) | 26 (8.6) |
| Dizziness | 2 (2.6) | 8 (5.1) | 7 (6.6) | 7 (9.0) | 23 (7.6) |
| ALT increased | 3 (3.9) | 6 (3.8) | 12 (11.3) | 2 (2.6) | 21 (7.0) |
| Sinusitis | 4 (5.3) | 8 (5.1) | 5 (4.7) | 5 (6.4) | 21 (7.0) |
| Diarrhea | 5 (6.6) | 5 (3.2) | 7 (6.6) | 3 (3.8) | 20 (6.6) |
| Bronchitis | 4 (5.3) | 6 (3.8) | 4 (3.8) | 3 (3.8) | 17 (5.6) |
| AST increased | 2 (2.6) | 6 (3.8) | 11 (10.4) | 0 | 17 (5.6) |
| Cough | 2 (2.6) | 4 (2.5) | 6 (5.7) | 3 (3.8) | 15 (5.0) |
| Patients with any rash | 3 (3.9) | 16 (10.1) | 19 (17.9) | 9 (11.5) | 46 (15.3) |
| Localized | 2 (2.6) | 6 (3.8) | 6 (5.7) | 2 (2.6) | 16 (5.3) |
| Acne | 0 | 5 (3.2) | 6 (5.7) | 3 (3.8) | 14 (4.7) |
| Generalized | 1 (1.3) | 5 (3.2) | 6 (5.7) | 2 (2.6) | 14 (4.7) |
| No information available | 0 | 0 | 2 (1.8) | 2 (2.6) | 4 (1.3) |