Patients with AEs, n (%) | SEC 300 mg, n = 103 | SEC 150 mg, n = 103 | Placebo, n = 52 |
---|---|---|---|
Any AE | 59 (57.3) | 61 (59.2) | 27 (51.9) |
Serious AEs | 2 (1.9) | 2 (1.9) | 2 (3.8) |
Death | 0 | 0 | 1 (1.9) |
Discontinuation due to AEs | 1 (1.0) | 1 (1.0) | 0 |
Common AEs (≥ 3% in any treatment group) | |||
Diarrhea | 6 (5.8) | 6 (5.8) | 1 (1.9) |
Upper respiratory tract infection | 6 (5.8) | 2 (1.9) | 0 |
Hypertension | 5 (4.9) | 4 (3.9) | 0 |
Sinus congestion | 4 (3.9) | 0 | 0 |
Fatigue | 3 (2.9) | 5 (4.9) | 0 |
Headache | 3 (2.9) | 4 (3.9) | 2 (3.8) |
Nasopharyngitis | 3 (2.9) | 4 (3.9) | 1 (1.9) |
Abdominal pain | 2 (1.9) | 2 (1.9) | 2 (3.8) |
Musculoskeletal pain | 2 (1.9) | 1 (1.0) | 3 (5.8) |
Sinusitis | 2 (1.9) | 1 (1.0) | 2 (3.8) |
Arthralgia | 1 (1.0) | 2 (1.9) | 4 (7.7) |
Back pain | 1 (1.0) | 4 (3.9) | 0 |
Pain in extremity | 1 (1.0) | 3 (2.9) | 3 (5.8) |
Peripheral edema | 1 (1.0) | 0 | 2 (3.8) |
Psoriasis | 1 (1.0) | 4 (3.9) | 0 |
Psoriatic arthropathy | 1 (1.0) | 4 (3.9) | 0 |
Respiratory tract congestion | 0 | 0 | 2 (3.8) |
Selected AEs of interest | |||
Candidiasis | |||
Candida infection | 1 (1.0) | 2 (1.9) | 0 |
Skin Candida | 0 | 1 (1.0) | 0 |
Major cardiac AEs | |||
Myocardial infarction | 0 | 1 (1.0) | 0 |
Ischemic stroke | 0 | 0 | 1 (1.9) |
Neutropenia | 1 (1.0) | 0 | 0 |
Values are expressed as n (%) unless otherwise stated. AE: adverse event; SEC: secukinumab.