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Table 4 Summary of grade 3 and 4 laboratory and hematologic toxicities

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

Parameter Grade 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)
Activated partial thromboplastin time 3 0 0 1 (7) 0 1 (7) 2 (4)
Creatinine 3 0 0 0 0 1 (7)a 1 (2)
Hemoglobin 3 0 1 (7) 0 0 0 1 (2)
Hyperglycemia 3 0 1 (7)   0 0 1 (2)
Neutropenia 3 0 0 1 (7)b 2 (14) 0 3 (5)
Thrombocytopenia 4 0 0 1 (7)b 0 0 1 (2)
Proteinuria 3 0 0 0 1 (7) 1 (7)a 2 (4)
  4 0 0 0 0 1 (7) 1 (2)
Prothrombin time 3 3 (23)c 1 (7)c 0 0 0 1 (2)
  4 2 (15)c 0 0 0 0 0
  1. Values are expressed as n (%). aOne patient had grade 3 serum creatinine and grade 3 proteinuria. bOne patient with grade 3 neutropenia and grade 4 thrombocytopenia after the first 10-mg/kg dose was rechallenged at grade 1 neutropenia, without further decline after the second dose. cFour of six patients with grade 3 or 4 prothrombin time reported concomitant warfarin use, including the two patients with grade 4 prothrombin time.