Table 4.

Most Common Grade ≥3 Adverse Events (Overall Incidence ≥ 1.0%)

System Organ Class     Preferred Term n (%)	Lenzilumab N=255	Placebo N=257	Total N=512
Any AE ≥ Grade 3	68 (26.7)	84 (32.7)	152 (29.7)
Respiratory, thoracic and mediastinal disorders	64 (25.1)	71 (27.6)	135 (26.4)
Respiratory failure	24 (9.4)	31 (12.1)	55 (10.7)
Acute respiratory failure	18 (7.1)	22 (8.6)	40 (7.8)
Hypoxia	15 (5.9)	15 (5.8)	30 (5.9)
Pulmonary embolism	5 (2.0)	3 (1.2)	8 (1.6)
Acute respiratory distress syndrome	4 (1.6)	3 (1.2)	7 (1.4)
Cardiac disorders	15 (5.9)	14 (5.4)	29 (5.7)
Cardiac arrest	8 (3.1)	4 (1.6)	12 (2.3)
Cardio-respiratory arrest	3 (1.2)	4 (1.6)	7 (1.4)
Infections and infestations	10 (3.9)	16 (6.2)	26 (5.1)
Septic shock	5 (2.0)	9 (3.5)	14 (2.7)
Sepsis	2 (0.8)	5 (1.9)	7 (1.4)
Pneumonia bacterial	0 (0.0)	6 (2.3)	6 (1.2)
Vascular disorders	10 (3.9)	15 (5.8)	25 (4.9)
Shock	3 (1.2)	6 (2.3)	9 (1.8)
Hypotension	2 (0.8)	5 (1.9)	7 (1.4)
Renal and urinary disorders	5 (2.0)	11 (4.3)	16 (3.1)
Acute kidney injury	5 (2.0)	8 (3.1)	13 (2.5)
General disorders and administration site conditions	4 (1.6)	11 (4.3)	15 (2.9)
Multiple organ dysfunction syndrome	3 (1.2)	6 (2.3)	9 (1.8)