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Table 2 Treatment-emergent and treatment-related adverse events

From: Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study

Adverse event, n (%) Placebo MEDI-551
0.1 mg/kg 0.3 mg/kg 1.0 mg/kg 3.0 mg/kg 10 mg/kg Total
(n = 4) (n = 1) (n = 4) (n = 6) (n = 6) (n = 7) (N = 24)
≥1 TEAE 3 (75.0) 1 (100.0) 4 (100.0) 6 (100.0) 5 (83.3) 7 (100.0) 23 (95.8)
≥1 grade 3 TEAE 0 1 (100.0) 0 2 (33.3) 2 (33.3) 2 (28.6) 7 (29.2)
≥1 grade 4 TEAE 0 0 0 0 1 (16.7) 0 1 (4.2)
Death 0 0 0 0 1 (16.7) 0 0
≥1 SAE 0 1 (100.0) 1 (25.0) 1 (16.7) 2 (33.3) 1 (14.3) 6 (25.0)
≥1 study drug-related TEAE 0 0 2 (50.0) 4 (66.7) 4 (66.7) 4 (57.1) 14 (58.3)
≥1 study drug-related SAE 0 0 1 (25.0) 1 (16.7) 0 0 2 (8.3)
Treatment-related TEAEs and SAEs, by MedDRA preferred term
Infusion-related reaction 0 0 1 (25.0) 2 (33.3) 1 (16.7) 0 4 (16.7)
Cough 0 0 0 0 0 2 (28.6) 2 (8.3)
Diarrhea 0 0 0 0 1 (16.7) 0 1 (4.2)
Fatigue 0 0 0 0 0 1 (14.3) 1 (4.2)
Flushing 0 0 0 1 (16.7) 0 0 1 (4.2)
Headache 0 0 0 0 0 1 (14.3) 1 (4.2)
Hot flush 0 0 0 1 (16.7) 0 0 1 (4.2)
Hyperglycemia 0 0 0 0 1 (16.7) 0 1 (4.2)
Lip swelling 0 0 0 0 1 (16.7) 0 1 (4.2)
Night sweats 0 0 0 0 0 1 (14.3) 1 (4.2)
Rash 0 0 0 0 1 (16.7) 0 1 (4.2)
Subclavian vein thrombosis 0 0 0 1 (16.7) 0 0 1 (4.2)
Supraventricular extrasystoles 0 0 0 0 0 1 (14.3) 1 (4.2)
Supraventricular tachycardia 0 0 1 (25.0) 0 0 0 1 (4.2)
Tongue ulceration 0 0 0 0 0 1 (14.3) 1 (4.2)
Upper respiratory tract infection 0 0 0 0 1 (16.7) 0 1 (4.2)
  1. MedDRA Medical Dictionary for Regulatory Activities, SAE serious adverse event, TEAE treatment-emergent adverse event,
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Arthritis Research & Therapy

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