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Table 2 TEAEs in >1 patient by system organ class

From: Phase 1b randomized, double-blind study of namilumab, an anti-granulocyte macrophage colony-stimulating factor monoclonal antibody, in mild-to-moderate rheumatoid arthritis

System organ class, na (%) Placebo (n = 9) Namilumab 150 mg (n = 8) Namilumab 300 mg (n = 7) Total (N = 24)
Preferred term, na (%)
Any TEAE 5 (56) 5 (63) 4 (57) 14 (58)
Musculoskeletal and connective tissue disorders 3 (33) 3 (38) 0 6 (25)
 Exacerbation/worsening of RA 2 (22) 1 (13) 0 3 (13)
 Musculoskeletal pain 0 2 (25) 0 2 (8)
 Pain in extremity 1 (11) 0 0 1 (4)
 Muscular weakness 1 (11) 0 0 1 (4)
Laboratory investigations (total)b 1 (11) 3 (38) 2 (29) 6 (25)
Infections and infestations 2 (22) 3 (38) 0 5 (21)
 Nasopharyngitis 2 (22) 2 (25) 0 4 (17)
 Urinary tract infection 0 1 (13) 0 1 (4)
Gastrointestinal disorders 0 2 (25) 1 (14) 3 (13)
 Abdominal pain, upper 0 1 (13) 0 1 (4)
 Diarrhea 0 1 (13) 0 1 (4)
 Abdominal pain 0 0 1 (14) 1 (4)
Cardiac disorders 1 (11) 1 (13) 0 2 (8)
 Bradycardia 1 (11) 0 0 1 (4)
 Coronary artery stenosis 0 1 (13) 0 1 (4)
General disorders and administrative site conditions 1 (11) 0 1 (14) 2 (8)
 Chest discomfort 1 (11) 0 0 1 (4)
 Chest pain 0 0 1 (14) 1 (4)
 Influenza-like illness 0 0 1 (14) 1 (4)
Nervous system disorders 1 (11) 1 (13) 0 2 (8)
 Paresthesia 0 1 (13) 0 1 (4)
 Somnolence 1 (11) 0 0 1 (4)
Renal and urinary disorders 1 (11) 0 1 (14) 2 (8)
 Dysuria 1 (11) 0 0 1 (4)
 Nephrolithiasis 0 0 1 (14) 1 (4)
  1. RA rheumatoid arthritis, TEAE treatment-emergent adverse event
  2. aNumber of patients with ≥1 event in the category; bof which: increased blood creatine phosphokinase (n = 2; 8%)
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Arthritis Research & Therapy

ISSN: 1478-6362

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