Table 4 Safety profile during week 16 (placebo-controlled period) and the entire safety reporting period
Variable | Through week 16 (placebo-controlled period)a | Entire safety-data period | ||||
|---|---|---|---|---|---|---|
Secukinumab IV-300 mg (N = 76) | Secukinumab IV-150 mg (N = 74) | Placebo (N = 75) | Any secukinumab 300 mg (N = 113) | Any secukinumab 150 mg (N = 110) | Any secukinumab (N = 223) | |
Exposure to study treatment, days, mean ± SD | 112.9 ± 14.2 | 117.4 ± 13.1 | 112.2 ± 19.4 | 410.7 ± 108.9 | 425.9 ± 92.4 | 418.2 ± 101.1 |
Number of patients (%) | Number of patients (incidence rate per 100 patient years) | |||||
Any AE | 34 (44.7) | 34 (45.9) | 33 (44.0) | 83 (152.7) | 90 (179.2) | 173 (165.4) |
Serious AE | 1 (1.3) | 0 (0.0) | 1 (1.3) | 6 (4.8) | 6 (4.8) | 12 (4.8) |
Discontinued due to AEs | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (3.5) | 4 (3.6) | 8 (3.6) |
Death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Common AEsa | ||||||
Nasopharyngitis | 3 (3.9) | 6 (8.1) | 2 (2.7) | 16 (13.7) | 22 (19.6) | 38 (16.6) |
Diarrhea | 3 (3.9) | 5 (6.8) | 0 (0.0) | 8 (6.6) | 9 (7.5) | 17 (7.0) |
Headache | 3 (3.9) | 5 (6.8) | 5 (6.7) | 11 (9.1) | 12 (10.1) | 23 (9.6) |
Cough | 3 (3.9) | 3 (4.1) | 1 (1.3) | 5 (4.1) | 3 (2.4) | 8 (3.2) |
Pharyngitis | 3 (3.9) | 1 (1.4) | 1 (1.3) | 4 (3.2) | 3 (2.4) | 7 (2.8) |
Ear infection | 3 (3.9) | 0 (0.0) | 0 (0.0) | 3 (2.4) | 0 | 3 (1.2) |
Urinary tract infection | 3 (3.9) | 0 (0.0) | 3 (4.0) | 6 (4.9) | 3 (2.4) | 9 (3..6) |
AEs of special interest | ||||||
Candida infection | 1 (1.4) | 1 (1.3) | 0 (0.0) | 2 (1.8) | 2 (1.8) | 4 (1.8) |
Malignant tumor | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
Neutropenia | ||||||
Grade 3 | 0 (0.0) | 1 (1.4) | 0 (0.0) | 1 (0.9) | 1 (0.9) | 2 (0.9) |
Grade 4 | 0 (0.0) | 2 (2.7) | 0 (0.0) | 0 (0.0) | 2 (1.8) | 2 (0.9) |