Table 1.

Treatment-related adverse events by treatment assignment

	REGN5381, i.v.
	Placebo, i.v. total	0.3 mg	1 mg	3 mg	10 mg	30 mg	100 mg	Total
Primary SOC PT	n = 12	n = 6	n = 6	n = 6	n = 6	n = 6	n = 6	n = 36
Number of treatment-related TEAEs	11	4	1	3	4	8	6	26
Participants with at least one treatment-related TEAE, n (%)	4 (33.3)	3 (50.0)	1 (16.7)	2 (33.3)	3 (50.0)	3 (50.0)	3 (50.0)	15 (41.7)
Nervous system disorders, n (%)	4 (33.3)	2 (33.3)	0	0	1 (16.7)	3 (50.0)	2 (33.3)	8 (22.2)
Dizziness postural	2 (16.7)	1 (16.7)	0	0	1 (16.7)	3 (50.0)	1 (16.7)	6 (16.7)
Dizziness	1 (8.3)	0	0	0	0	0	1 (16.7)	1 (2.8)
Headache	1 (8.3)	1 (16.7)	0	0	0	0	0	1 (2.8)
Presyncope	0	0	0	0	0	0	1 (16.7)	1 (2.8)
Cardiac disorders, n (%)	1 (8.3)	1 (16.7)	1 (16.7)	1 (16.7)	1 (16.7)	0	1 (16.7)	5 (13.9)
Palpitations	1 (8.3)	0	1 (16.7)	0	1 (16.7)	0	1 (16.7)	3 (8.3)
Ventricular tachycardia	0	1 (16.7)	0	1 (16.7)	0	0	0	2 (5.6)
Vascular disorders, n (%)	0	1 (16.7)	0	0	1 (16.7)	2 (33.3)	1 (16.7)	5 (13.9)
Orthostatic hypotension	0	0	0	0	1 (16.7)	2 (33.3%)	1 (16.7)	4 (11.1)
Diastolic hypotension	0	1 (16.7)	0	0	0	0	0	1 (2.8)
Gastrointestinal disorders, n (%)	1 (8.3)	0	0	1 (16.7)	0	2 (33.3)	1 (16.7)	4 (11.1)
Nausea	0	0	0	0	0	2 (33.3)	1 (16.7)	3 (8.3)
Diarrhoea	1 (8.3)	0	0	1 (16.7)	0	0	0	1 (2.8)
Vomiting	0	0	0	1 (16.7)	0	0	0	1 (2.8)
General disorders and administration site conditions, n (%)	2 (16.7)	0	0	0	1 (16.7)	1 (16.7)	0	2 (5.6)
Feeling hot	2 (16.7)	0	0	0	1 (16.7)	1 (16.7)	0	2 (5.6)

The Medical Dictionary for Regulatory Activities (MedDRA) (v.25.1) coding dictionary was applied. At each level of participant summarization, a participant is counted once if the participant reported one or more events. i.v., intravenous; SOC, system organ class; PT, preferred term.