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Table 2 Frequently reported (>10% overall and >1 subject in any group) treatment-emergent adverse events and laboratory abnormalities

From: Dose-escalation of human anti-interferon-α receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study

  MEDI-546
0.1 mg/kg single dose 0.3 mg/kg single dose 1.0 mg/kg single dose 3.0 mg/kg single dose 10.0 mg/kg single dose 20.0 mg/kg single dose 0.3 mg/kg/week multiple dose 1.0 mg/kg/week multiple dose 5.0 mg/kg/week multiple dose Total
  (n = 1) (n = 4) (n = 4) (n = 4) (n = 4) (n = 4) (n = 4) (n = 4) (n = 5) (N = 34)
TEAEs
Total number of TEAEs 1 10 15 15 18 11 20 20 38 148
Total subjects reporting ≥1 TEAEs, n (%) 1 (100.0) 4 (100.0) 4 (100.0) 4 (100.0) 4 (100.0) 4 (100.0) 4 (100.0) 4 (100.0) 5 (100.0) 34 (100.0)
Upper respiratory tract infection, n (%)a 0 (0.0) 2 (50.0) 1 (25.0) 2 (50.0) 0 (0.0) 2 (50.0) 0 (0.0) 3 (75.0) 0 (0.0) 10 (29.4)
Headache, n (%)a 0 (0.0) 1 (25.0) 0 (0.0) 0 (0.0) 2 (50.0) 1 (25.0) 2 (50.0) 1 (25.0) 0 (0.0) 7 (20.6)
Diarrhea, n (%)a 0 (0.0) 0 (0.0) 3 (75.0) 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (25.0) 1 (20.0) 6 (17.6)
Nausea, n (%)a 0 (0.0) 0 (0.0) 0 (0.0) 1 (25.0) 2 (50.0) 1 (25.0) 0 (0.0) 1 (25.0) 1 (20.0) 6 (17.6)
Arthralgia, n (%)a 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (25.0) 1 (25.0) 0 (0.0) 4 (11.8)
Fatigue, n (%)a 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (25.0) 1 (25.0) 0 (0.0) 4 (11.8)
Pruritus, n (%)a 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 1 (25.0) 0 (0.0) 0 (0.0) 1 (25.0) 1 (20.0) 4 (11.8)
Dizziness, n (%)a 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (40.0) 3 ( 8.8)
Musculoskeletal chest pain, n (%)a 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (40.0) 3 ( 8.8)
Urticaria, n (%)a 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 2 (40.0) 3 ( 8.8)
Constipation, n (%)a 0 (0.0) 2 (50.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (5.9)
Depression, n (%)a 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (40.0) 2 (5.9)
Laboratory abnormalities
Anemiab,c, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (20.0) 1 (2.9)
Decreased hemoglobind, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (20.0) 1 (2.9)
Decreased absolute lymphocyte countd, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (20.0) 1 (2.9)
Elevated aspartate aminotransferase valuee, n (%) 0 (0.0) 1 (25.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.9)
Hyperglycemiab, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (2.9)
Hematuriab, n (%) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (25.0) 0 (0.0) 0 (0.0) 1 (2.9)
  1. aPreferred term according to the Medical Dictionary for Regulatory Activities version 14.0.
  2. bLaboratory abnormality reported as a TEAE.
  3. cGrade 1 in severity.
  4. dGrade 3 in severity.
  5. eGrade 2 in severity.
  6. TEAE treatment-emergent adverse event.
  7. Note: Subjects were counted only once for each preferred term, regardless of how many events the subject reported.
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Arthritis Research & Therapy

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