Table 3 Safety profile during the placebo-controlled period and the entire safety-reporting period
Variable | Through week 16 (placebo-controlled period) | Entire safety-data period | ||||
|---|---|---|---|---|---|---|
Secukinumab 300 mg (N = 139) | Secukinumab 150 mg (N = 138) | Placebo (N = 137) | Any secukinumab 300 mg (N = 204) | Any secukinumab 150 mg (N = 202) | Any secukinumab (N = 406) | |
Exposure to study treatment (days), mean ± SD | 403.8 ± 108.3 | 392.3 ± 115.8 | 398.1 ± 112.1 | |||
Any AE | 76 (54.7) | 80 (58.0) | 77 (56.2) | 164 (194.9) | 156 (192.5) | 320 (193.7) |
Any serious AE | 3 (2.2) | 5 (3.6) | 9 (6.6) | 19 (8.8) | 21 (10.2) | 40 (9.5) |
Discontinued due to AEsa | 3 (2.2) | 5 (3.6) | 5 (3.6) | 9 (4.4) | 13 (6.4) | 22 (5.4) |
Deathb | 0 | 0 | 0 | 0 | 2 (1.0) | 2 (0.5) |
Common AEsc | ||||||
Nasopharyngitis | 13 (9.4) | 11 (8.0) | 13 (9.5) | 47 (25.0) | 30 (15.5) | 77 (20.2) |
Upper respiratory tract infection | 7 (5.0) | 6 (4.3) | 5 (3.6) | 23 (10.9) | 19 (9.3) | 42 (10.1) |
Diarrhea | 4 (2.9) | 7 (5.1) | 2 (1.5) | 16 (7.5) | 15 (7.2) | 31 (7.4) |
Back pain | 5 (3.6) | 4 (2.9) | 1 (0.7) | 16 (7.5) | 12 (5.7) | 28 (6.6) |
Headache | 6 (4.3) | 9 (6.5) | 6 (4.4) | 11 (5.1) | 15 (7.3) | 26 (6.1) |
Arthralgia | 4 (2.9) | 1 (0.7) | 1 (0.7) | 12 (5.5) | 13 (6.3) | 25 (5.9) |
Bronchitis | 3 (2.2) | 2 (1.4) | 5 (3.6) | 15 (6.9) | 9 (4.3) | 24 (5.6) |
Fatigue | 5 (3.6) | 4 (2.9) | 2 (1.5) | 7 (3.2) | 15 (7.3) | 22 (5.2) |
Urinary tract infection | 6 (4.3) | 3 (2.2) | 2 (1.5) | 13 (6.0) | 9 (4.2) | 22 (5.1) |
AEs of special interest | ||||||
Myocardial infarction | 0 | 0 | 0 | 0 | 1 (0.5) | 1 (0.2) |
Neutropenia | 0 | 0 | 0 | 1 (0.4) | 2 (0.9) | 3 (0.7) |
Candida infection | 0 | 2 (1.4) | 2 (1.5) | 6 (2.7) | 8 (3.8) | 14 (3.2) |
IBD | 0 | 0 | 1 (0.7) | 1 (0.4) | 0 | 1 (0.2) |