TEAEs by SOC and PT
TEAEs (any TEAE ≥2.5% in any treatment group)—n (%) | Brodalumab 210 mg N=80 | Placebo N=79 |
Infections and infestations | 18 (22.5) | 15 (19.0) |
Nasopharyngitis | 8 (10.0) | 9 (11.4) |
Rhinitis | 3 (3.8) | 1 (1.3) |
Upper respiratory tract infection | 2 (2.5) | 5 (6.3) |
Gastrointestinal disorders | 13 (16.3) | 7 (8.9) |
Diarrhoea | 3 (3.8) | 1 (1.3) |
Mouth ulceration | 3 (3.8) | 1 (1.3) |
Abdominal pain upper | 2 (2.5) | 0 |
Vomiting | 2 (2.5) | 0 |
Investigations | 7 (8.8) | 1 (1.3) |
Alanine aminotransferase increased | 4 (5.0) | 1 (1.3) |
Aspartate aminotransferase increased | 4 (5.0) | 1 (1.3) |
Liver function test abnormal | 2 (2.5) | 0 |
Musculoskeletal and connective tissue disorders | 6 (7.5) | 6 (7.6) |
Back pain | 0 | 2 (2.5) |
Injury, poisoning and procedural complications | 5 (6.3) | 6 (7.6) |
Ligament sprain | 1 (1.3) | 2 (2.5) |
Metabolism and nutrition disorders | 4 (5.0) | 2 (2.5) |
Nervous system disorders | 3 (3.8) | 2 (2.5) |
Skin and subcutaneous tissue disorders | 3 (3.8) | 5 (6.3) |
Pruritus | 2 (2.5) | 1 (1.3) |
General disorders and administration site conditions | 2 (2.5) | 6 (7.6) |
Fatigue | 1 (1.3) | 2 (2.5) |
Respiratory, thoracic and mediastinal disorders | 2 (2.5) | 3 (3.8) |
Vascular disorders | 2 (2.5) | 2 (2.5) |
Hypertension | 2 (2.5) | 2 (2.5) |
PT, preferred term; SOC, system organ class; TEAE, treatment-emergent adverse event.