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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%)