Table 3.
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.