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Table 5 Summary of adverse events through 24 weeks

From: A phase 2 randomized, double-blind study of AMG 108, a fully human monoclonal antibody to IL-1R, in patients with rheumatoid arthritis

   AMG 108
  Placebo
(n= 201)
50 mg
(n= 202)
125 mg
(n= 201)
250 mg
(n= 201)
Totala
(n= 604)
Any AE 133 (66.2) 134 (66.3) 143 (71.1) 135 (67.2) 412 (68.2)
Most common AE      
   Headache 16 (8.0) 11 (5.4) 15 (7.5) 15 (7.5) 41 (6.8)
   Diarrhea 13 (6.5) 10 (5.0) 11 (5.5) 15 (7.5) 36 (6.0)
   Nasopharyngitis 18 (9.0) 11 (5.4) 13 (6.5) 12 (6.0) 36 (6.0)
   URI 15 (7.5) 10 (5.0) 13 (6.5) 13 (6.5) 36 (6.0)
Treatment-related AE 48 (23.9) 43 (21.3) 50 (24.9) 45 (22.4) 138 (22.8)
AE leading to:      
   Study discontinuation 1 (0.5) 3 (1.5) 3 (1.5) 3 (1.5) 9 (1.5)
   Withdrawal of study drug 2 (1.0) 4 (2.0) 4 (2.0) 3 (1.5) 11 (1.8)
   Hospitalization 9 (4.5) 5 (2.5) 5 (2.5) 6 (3.0) 16 (2.6)
Any infection 72 (35.8) 64 (31.7) 68 (33.8) 62 (30.8) 194 (32.1)
Infection leading to:      
   Study discontinuation 1 (0.5) 0 0 1 (0.5) 1 (0.2)
   Withdrawal of study drug 0 1 (0.5) 0 1 (0.5) 2 (0.3)
   Hospitalization 3 (1.5) 1 (0.5) 1 (0.5) 2 (1.0) 4 (0.7)
Injection site reaction 5 (2.5) 8 (4.0) 10 (5.0) 9 (4.5) 27 (4.5)
Any serious AE 11 (5.5) 6 (3.0) 6 (3.0) 9 (4.5) 21 (3.5)
Treatment-related serious AE 2 (1.0) 2 (1.0) 1 (0.5) 1 (0.5) 4 (0.7)
Serious infection 3 (1.5) 2 (1.0) 1 (0.5) 2 (1.0) 5 (0.8)
Death 0 0 0 0 0
  1. Data presented as n (%). AE, adverse event; URI, upper respiratory infection. aAll randomized patients who received at least one dose of AMG 108.