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Table 3 Incidence (three or more patients) of adverse events by dose: single-dose and double-dose cohorts combined

From: Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus

Adverse event Placebo (n = 13) Belimumab
   1.0 mg/kg (n = 15) 4.0 mg/kg (n = 14) 10 mg/kg (n = 14) 20 mg/kg (n = 14) All active (n = 57)
Arthralgia 4 (31) 3 (20) 2 (14) 7 (50) 3 (21) 15 (26)
Headache 1 (8) 3 (20) 3 (21) 4 (29) 2 (14) 12 (21)
Rash 0 4 (27) 2 (14) 2 (14) 4 (29) 12 (21)
Diarrhea 0 5 (33) 1 (7) 1 (7) 3 (21) 10 (18)
Nausea 4 (31) 2 (13) 3 (21) 2 (14) 3 (21) 10 (18)
Fatigue 0 1 (7) 2 (14) 3 (21) 1 (7) 7 (12)
Back pain 1 (8) 0 2 (14) 1 (7) 3 (21) 6 (11)
Joint swelling 2 (15) 0 1 (7) 0 4 (29) 5 (9)
Synovitis 1 (8) 2 (13) 0 3 (21) 0 5 (9)
Depression 0 3 (20) 0 0 0 3 (5)
Infections and infestations 8 (62) 4 (27) 8 (57) 4 (29) 5 (36) 21 (37)
Upper respiratory tract infection 2 (15) 0 3 (21) 1 (7) 3 (21) 7 (12)
Thrombocytopeniaa 0 0 1 (7) 0 0 1 (2)
Pancreatitisb 0 0 0 0 1 (7) 1 (2)
Cellulitis staphylococcalb 0 0 0 1 (7) 0 1(2)
Sepsisb 1 (8) 0 0 0 0 0
Aspartate aminotransferase increasedb 0 0 0 0 1 (7) 1 (2)
Blood creatinine increasedb 0 0 0 0 1 (7) 1 (2)
Neutrophil count decreasedb 0 0 0 2 (14) 0 2 (4)
Dehydrationb 0 0 0 0 1 (7) 1 (2)
Pain in extremityb 0 0 1 (7) 0 0 1 (2)
Headacheb 0 0 0 1 (7) 0 1 (2)
Sinus headacheb 0 1 (7) 0 0 0 1 (2)
Angioneurotic edemab 0 0 1 (7) 0 0 1 (2)
Urticariab 0 0 0 0 1 (7) 1 (2)
  1. Values are expressed as n (%). aGrade 4 potentially life-threatening adverse event. bGrade 3 severe adverse event