Table 3.

Serious treatment-emergent adverse events by system organ class and preferred term (safety population).

Cohort 1 with ACI-35.030
SOC PT [n (%)]	ACI-35.030 300 μg (N = 6)	ACI-35.030 900 μg (N = 19)	ACI-35.030 1800 μg (N = 6)	Cohort 1 placebo (N = 10)	Pooled placebo (N = 14)	Total (N = 41)
Any serious TEAEs	2 (33.3)	2 (10.5)	2 (33.3)	0	1 (7.1)	6 (14.6)
Infections and infestations	1 (16.7)	1 (5.3)	0	0	0	2 (4.9)
Diverticulitis	1 (16.7)	0	0	0	0	1 (2.4)
Hemorrhagic fever with renal syndrome	0	1 (5.3)	0	0	0	1 (2.4)
Cardiac disorders	1 (16.7)	0	0	0	0	1 (2.4)
Sinus node dysfunction	1 (16.7)	0	0	0	0	1 (2.4)
Gastrointestinal disorders	0	0	1 (16.7)	0	0	1 (2.4)
Diverticulum	0	0	1 (16.7)	0	0	1 (2.4)
General disorders and administration site conditions	0	1 (5.3)	0	0	0	1 (2.4)
Injection site rash	0	1 (5.3)	0	0	0	1 (2.4)
Injury, poisoning, and procedural complications	0	1 (5.3)	0	0	0	1 (2.4)
Post-traumatic pain	0	1 (5.3)	0	0	0	1 (2.4)
Nervous system disorders	0	1 (5.3)	0	0	0	1 (2.4)
Dizziness	0	1 (5.3)	0	0	0	1 (2.4)
Vascular disorders	0	0	1 (16.7)	0	0	1 (2.4)
Aneurysm thrombosis	0	0	1 (16.7)	0	0	1 (2.4)
Peripheral artery aneurysm	0	0	1 (16.7)	0	0	1 (2.4)
Musculoskeletal and connective tissue disorders	0	0	0	0	1 (7.1)	0
Intervertebral disc protrusion	0		0	0	1 (7.1)	0

Cohort 2 with JACI-35.054
SOC PT [n (%)]	JACI-35.054 15 μg (N = 6)	JACI-35.054 60 μg (N = 6)	Cohort 2 placebo (N = 4)	Pooled placebo (N = 14)	Total (N = 16)
Any serious TEAEs	0	0	1 (25.0)	1 (7.1)	1 (6.3)
Musculoskeletal and connective tissue disorders	0	0	1 (25.0)	1 (7.1)	1 (6.3)
Intervertebral disc protrusion	0	0	1 (25.0)	1 (7.1)	1 (6.3)

n = Number of participants; PT = preferred term; SOC = system organ class.

For each SOC and PT, participants are included only once.