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

Table 2 Treatment-emergent and treatment-related adverse events

Adverse event, n (%)	Placebo	MEDI-551
	Placebo	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)

MedDRA Medical Dictionary for Regulatory Activities, SAE serious adverse event, TEAE treatment-emergent adverse event,

ISSN: 1478-6362