Adverse events during the double-blind period and open-label period. Affected system organ classes listed here are those reported in at least 10% of patients; preferred terms are those reported in at least 5% of patients within the affected system organ class. Data are n (%).
| Variables | Adverse Events up to Week 16 | Adverse Events during Open-label Period | ||||||
|---|---|---|---|---|---|---|---|---|
| Secukinumab IV Loading, n = 88 | Secukinumab SC Loading, n = 89 | Any Secukinumab, n = 177 | PBO, n = 44 | Secukinumab IV Loading, n = 86 | Secukinumab SC Loading, n = 84 | PBO–Secukinumab, n = 44 | Any Secukinumab, n = 214 | |
| Any adverse event | 36 (40.9) | 45 (50.6) | 81 (45.8) | 19 (43.2) | 51 (59.3) | 52 (61.9) | 21 (47.7) | 124 (57.9) |
| Deaths | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any serious adverse event | 2 (2.3) | 3 (3.4) | 5 (2.8) | 1 (2.3) | 6 (7.0) | 10 (11.9) | 2 (4.5) | 18 (8.4) |
| Discontinuations because of adverse event | 1 (1.1) | 3 (3.4) | 4 (2.3) | 0 | 3 (3.5) | 4 (4.8) | 2 (4.5) | 9 (4.2) |
| Infections and infestations | 19 (21.6) | 16 (18.0) | 35 (19.8) | 10 (22.7) | 28 (32.6) | 29 (34.5) | 13 (29.5) | 70 (32.7) |
| Nasopharyngitis | 5 (5.7) | 5 (5.6) | 10 (5.6) | 4 (9.1) | 3 (3.5) | 4 (4.8) | 4 (9.1) | 11 (5.1) |
| Upper respiratory tract infection | 1 (1.1) | 1 (1.1) | 2 (1.1) | 0 | 8 (9.3) | 7 (8.3) | 2 (4.5) | 17 (7.9) |
| Pharyngitis | 0 | 1 (1.1) | 1 (0.6) | 0 | 1 (1.2) | 5 (6.0) | 0 | 6 (2.8) |
| Oral herpes | 0 | 1 (1.1) | 1 (0.6) | 3 (6.8) | 2 (2.3) | 3 (3.6) | 0 | 5 (2.3) |
| Musculoskeletal and connective tissue disorders | 3 (3.4) | 11 (12.4) | 14 (7.9) | 3 (6.8) | 14 (16.3) | 14 (16.7) | 6 (13.6) | 34 (15.9) |
| Rheumatoid arthritis | 0 | 5 (5.6) | 5 (2.8) | 2 (4.5) | 7 (8.1) | 4 (4.8) | 2 (4.5) | 13 (6.1) |
| Gastrointestinal disorders | 8 (9.1) | 7 (7.9) | 15 (8.5) | 1 (2.3) | 7 (8.1) | 10 (11.9) | 2 (4.5) | 19 (8.9) |
| Respiratory, thoracic, and mediastinal disorders | 4 (4.5) | 3 (3.4) | 7 (4.0) | 2 (4.5) | 8 (9.3) | 4 (4.8) | 5 (11.4) | 17 (7.9) |
| Cough | 0 | 1 (1.1) | 1 (0.6) | 0 | 2 (2.3) | 2 (2.4) | 3 (6.8) | 7 (3.3) |
IV: intravenous; SC: subcutaneous; PBO: placebo.