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Table 3 Treatment-emergent adverse events by preferred term occurring in at least two patients from all pateclizumab-treated groups combined during either single or multiple ascending dose phasesa

From: Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial

  SAD cohorts, n(%) MAD cohorts, n(%)
Adverse events Placebo
(n= 6)
All active
(n= 24)
Placebo
(n= 7)
1.0 mg/kg SC
(n= 8)
3.0 mg/kg SC
(n= 16)
5.0 mg/kg IV
(n= 4)
All active
(n= 28)
Any event 3 (50.0) 20 (66.7) 4 (57.1) 7 (87.5) 8 (50.0) 1 (25.0) 20 (57.1)
Fatigue 0 (0.0) 2 (8.3) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Rheumatoid arthritis 0 (0.0) 2 (8.3) 0 (0.0) 1 (12.5) 1 (6.3) 0 (0.0) 2 (7.1)
Rash 0 (0.0) 2 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Diarrhea 0 (0.0) 1 (4.2) 0 (0.0) 3 (37.5) 1 (6.3) 0 (0.0) 4 (14.3)
Vomiting 0 (0.0) 0 (0.0) 0 (0.0) 2 (25.0) 0 (0.0) 0 (0.0) 2 (7.1)
Nasopharyngitis 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (12.5) 0 (0.0) 2 (7.1)
Headache 0 (0.0) 1 (4.2) 0 (0.0) 2 (25.0) 1 (6.3) 1 (25.0) 4 (14.3)
Rhinorrhea 0 (0.0) 0 (0.0) 0 (0.0) 1 (12.5) 1 (6.3) 0 (0.0) 2 (7.1)
  1. aIV = intravenously; MAD = multiple ascending dose; SAD = single ascending dose; SC = subcutaneously.