TABLE 4.

Adverse Events

	Dapansutrile 500 mg (n = 8)	Dapansutrile 1000 mg (n = 8)	Dapansutrile 2000 mg (n = 8)	All Dapansutrile Subjects (n = 24)	Pooled Placebo Subjects (n = 6)
Subjects with at least 1 AE, n (%)	4 (50.0)	4 (50.0)	5 (62.5)	13 (54.2)	5 (83.3)
Total AEs, n	9	6	11	26	14
Cardiac disorders, n (%)	0 (0)	1 (12.5)	0 (0)	1 (4.2)	1 (16.7)
Atrial fibrillation, n (%)	0 (0)	1 (12.5)	0 (0)	1 (4.2)	0 (0)
Cardiac failure, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
GI disorders, n (%)	1 (12.5)	1 (12.5)	4 (50.0)	6 (25.0)	3 (50.0)
Abdominal discomfort, n (%)	0 (0)	1 (12.5)	0 (0)	1 (4.2)	1 (16.7)
Abdominal pain, n (%)	1 (12.5)	0 (0)	0 (0)	1 (4.2)	0 (0)
Diarrhea, n (%)	0 (0)	0 (0)	4 (50.0)	4 (16.7)	0 (0)
Flatulence, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
Nausea, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
General disorders and administration site conditions, n (%)	0 (0)	1 (12.5)	0 (0)	1 (4.2)	1 (16.7)
Edema, n (%)	0 (0)	1 (12.5)	0 (0)	1 (4.2)	1 (16.7)
Infections and infestations, n (%)	1 (12.5)	1 (12.5)	0 (0)	2 (8.3)	2 (33.3)
Nasopharyngitis, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
URTI, n (%)	0 (0)	1 (12.5)	0 (0)	1 (4.2)	1 (16.7)
UTI, n (%)	1 (12.5)	0 (0)	0 (0)	1 (4.2)	0 (0)
Investigations, n (%)	3 (37.5)	0 (0)	0 (0)	3 (12.5)	1 (16.7)
BP increase, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
Lipase increased, n (%)	3 (37.5)	0 (0)	0 (0)	3 (12.5)	0 (0)
Metabolism and nutrition disorders, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	1 (16.7)
Hyperglycemia, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
Hypokalemia, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	0 (0)
Musculoskeletal and connective tissue disorders, n (%)	1 (12.5)	1 (12.5)	1 (12.5)	3 (12.5)	1 (16.7)
Arthralgia, n (%)	1 (12.5)	1 (12.5)	1 (12.5)	3 (12.5)	0 (0)
Muscle spasms, n (%)	0 (0)	1 (12.5)	0 (0)	1 (4.2)	0 (0)
Neuropathic arthropathy, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
Nervous system disorders, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	2 (33.3)
Dizziness, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	0 (0)
Headache, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	2 (33.3)
Renal and urinary disorders, n (%)	1 (12.5)	0 (0)	0 (0)	1 (4.2)	1 (16.7)
Acute kidney injury, n (%)	1 (12.5)	0 (0)	0 (0)	1 (4.2)	1 (16.7)
Respiratory, thoracic, and mediastinal disorders, n (%)	1 (12.5)	0 (0)	0 (0)	1 (4.2)	0 (0)
Cough, n (%)	1 (12.5)	0 (0)	0 (0)	1 (4.2)	0 (0)
Skin and SCT disorders, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	1 (16.7)
Angioedema, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	0 (0)
Decubitus ulcer, n (%)	0 (0)	0 (0)	0 (0)	0 (0)	1 (16.7)
Vascular disorders, n (%)	0 (0)	0 (0)	3 (37.5)	3 (12.5)	0 (0)
Hypertension, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	0 (0)
Hypotension, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	0 (0)
Orthostatic hypertension, n (%)	0 (0)	0 (0)	1 (12.5)	1 (4.2)	0 (0)

GI, gastrointestinal; SCT, subcutaneous tissue; URTI, upper respiratory tract infection; UTI, urinary tract infection.