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. 2021 Apr 7;80(8):1014–1021. doi: 10.1136/annrheumdis-2020-219406

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.