Table 4.

Safety through day 28

	Placebo (N=102)	Nezulcitinib 3 mg (N=103)
Patients with any TEAE, n (%)*	42 (41.2)	35 (34.0)
Respiratory failure	9 (8.8)	3 (2.9)
Diarrhoea	7 (6.9)	3 (2.9)
ALT increased	6 (5.9)	6 (5.8)
Acute kidney injury	6 (5.9)	1 (1.0)
Acute respiratory distress syndrome	0	4 (3.9)
AST increased	0	4 (3.9)
Hypertension	0	4 (3.9)
Pulmonary embolism	4 (3.9)	0
Constipation	4 (3.9)	0
Hyperglycaemia	2 (2.0)	3 (2.9)
Cough	1 (1.0)	3 (2.9)
Multiple organ dysfunction syndrome	1 (1.0)	3 (2.9)
Acute respiratory failure	3 (2.9)	0
AESI	8 (7.8)	10 (9.7)
ALT increased	6 (5.9)	6 (5.8)
AST increased	0	4 (3.9)
Transaminase increased	0	2 (1.9)
Hepatic failure	2 (2.0)	1 (1.0)
Hepatic enzyme increased	0	1 (1.0)
SAE	16 (15.7)	10 (9.7)
Respiratory failure	5 (4.9)	3 (2.9)
Pulmonary embolism	4 (3.9)	0
Multiple organ dysfunction syndrome	1 (1.0)	3 (2.9)
Acute respiratory distress syndrome	0	3 (2.9)
Acute respiratory failure	3 (2.9)	0
Acute kidney injury	3 (2.9)	0
Shock	2 (2.0)	1 (1.0)
Cardiac arrest	2 (2.0)	0
Pneumothorax	1 (1.0)	1 (1.0)
Bacterial sepsis	1 (1.0)	1 (1.0)
Systemic bacterial infection	0	1 (1.0)
Ischaemic stroke	0	1 (1.0)
ALT increased	0	1 (1.0)
AST increased	0	1 (1.0)
Sudden death	1 (1.0)	0
Septic shock	1 (1.0)	0
Syncope	1 (1.0)	0
AE related to study drug	9 (8.8)	9 (8.7)
Death	13 (12.7)	6 (5.8)

All data shown as n (%) unless otherwise stated. AEs were mapped according to MedDRA V.23.1.

*Preferred terms reported for any AE with incidence over 2% in either group.

AE, adverse event; AESI, AEs of special interest; ALT, alanine aminotransferase; AST, aspartate aminotransferase; HR, hazard ratio; MedDRA, Medical Dictionary for Regulatory Affairs; SAE, serious AE; TEAE, treatment-emergent adverse event.