Table 3.

Summary of adverse events in the safety population.

Event	Nafamostat (N = 52)		SOC (N = 51)
n (%)	Any Grade	Grade ≥ 3	Any Grade	Grade ≥ 3
Any adverse event	25 (48.1)	5 (9.6)	16 (31.4)	8 (15.7)
Catheter site phlebitis	7 (13.5)	0 (0.0)	2 (3.9)	0 (0.0)
Hyponatraemia	4 (7.7)	0 (0.0)	0 (0.0)	0 (0.0)
Respiratory failure	3 (5.8)	1 (1.9)	1 (2.0)	1 (2.0)
Abdominal pain	3 (5.8)	0 (0.0)	0 (0.0)	0 (0.0)
Nausea	2 (3.8)	0 (0.0)	1 (2.0)	0 (0.0)
Procedural pneumothorax	2 (3.8)	1 (1.9)	0 (0.0)	0 (0.0)
Blood pressure increased	1 (1.9)	1 (1.9)	2 (3.9)	0 (0.0)
Hyperthermia	1 (1.9)	1 (1.9)	0 (0.0)	0 (0.0)
Blood pressure fluctuation	1 (1.9)	1 (1.9)	0 (0.0)	0 (0.0)
Diarrhoea	1 (1.9)	0 (0.0)	1 (2.0)	0 (0.0)
Chest pain	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Hepatitis	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Infusion related reaction	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Alanine aminotransferase increased	1 (1.9)	0 (0.0)	1 (2.0)	0 (0.0)
Blood bilirubin increased	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Electrocardiogram QT prolonged	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Glucose tolerance impaired	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Hyperglycaemia	1 (1.9)	0 (0.0)	1 (2.0)	1 (2.0)
Hypoglycaemia	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Hypotension	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Lymphostasis	1 (1.9)	0 (0.0)	0 (0.0)	0 (0.0)
Dyspnoea	0 (0.0)	0 (0.0)	3 (5.9)	2 (3.9)
Pulmonary embolism	0 (0.0)	0 (0.0)	2 (3.9)	2 (3.9)
Cardiac arrest	0 (0.0)	0 (0.0)	1 (2.0)	1 (2.0)
Serious adverse event	1 (1.9)		4 (7.8)
Respiratory failure	1 (1.9) †		1 (2.0) *
Procedural pneumothorax	1 (1.9) †		0 (0.0)
Multiple organ failure	1 (1.9) †*		0 (0.0)
Pulmonary embolism	0 (0.0)		2 (3.9) *
Cardiac arrest	0 (0.0)		1 (2.0) *

*Serious AE leading to death

^†Serious AEs reported in the same patient

Note. Not presented all AEs recorded in the SOC group and the grade 1 or 2 AEs but recorded in the SOC group only excluded from the table.