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Table 2 Summary of adverse events

From: A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee

  IV Administration SC Administration
Number (%) of patients with Placebo
(n= 8)
100 mg (n= 12) 300 mg (n= 12) All AMG 108 (n= 24) Placebo (n= 88) 75 mg (n= 12) 300 mg (n= 94)
Any adverse event 8 (100) 12 (100) 12 (100) 24 (100) 74 (84) 12 (100) 77 (82)
Most common AE        
   Headache 4 (50) 9 (75) 7 (58) 16 (57) 22 (25) 4 (33) 15 (16)
   Upper respiratory tract infection 1 (13) 2 (17) 5 (42) 7 (29) 7 (8) 6 (50) 9 (10)
Infection 3 (38) 4 (33) 8 (67) 12 (50) 18 (21) 7 (58) 25 (27)
Injection-site reaction 1 (13) 1 (8) 2 (17) 3 (13) 3 (3) 0 7 (7)
Treatment-related AE 5 (63) 8 (67) 6 (50) 14 (58) 10 (11) 0 28 (30)
AE leading to study discontinuation 0 0 0 0 1 (1) 0 1 (1)
Serious AE 0 0 2 (17) 2 (8) 3 (3) 0 2 (2)
Treatment-related SAE 0 0 1 (8) 1 (4) 0 0 1 (1)
Serious infectious AE 0 0 1 (8) 1 (4) 2 (2) 0 1 (1)
Death 0 0 1 (8) 1 (4) 0 0 0
  1. AE, adverse event; IV, intravenous; SAE, serious adverse event; SC, subcutaneous. SAEs were reported by two patients in the 300-mg IV group (hemorrhagic diarrhea and unstable angina in one; and lobar pneumonia, respiratory failure, multiorgan failure, sepsis, neutropenia, and leukopenia in the other); two patients in the 300-mg SC group (pancreatitis in one; and pneumonia and supraventricular tachycardia in the other); and three patients in the placebo SC group (arthropod bite and Staphylococcus infection in one; abdominal pain in the second; and coronary artery disease in the third). All serious infectious AEs have been listed as SAEs above and include one patient in the 300-mg IV group (lobar pneumonia and sepsis); one patient in the 300-mg SC group (pneumonia); and two patients in the placebo SC group (Staphylococcus infection in one and abdominal pain in the other).