Table 4

Most common grade≥3 adverse events (overall incidence ≥1.0%)

System organ class
preferred term n (%)
CRP <150 mg/LCRP ≥150 mg/LOverall
Lenzilumab
(n=181)
Placebo
(n=193)
Total
(n=374)
Lenzilumab
(n=59)
Placebo
(n=50)
Total
(n=109)
Total
(n=512)
Any AE ≥grade 332 (17)54 (28)86 (23)24 (41)16 (32)40 (37)152 (30)
Respiratory, thoracic and mediastinal disorders30 (17)48 (25)78 (21)23 (39)15 (30)38 (35)135 (26)
 Respiratory failure9 (5)22 (11)31 (8)55 (11)
 Acute respiratory failure8 (4)15 (8)23 (6)6 (10)6 (12)12 (11)40 (8)
 Hypoxia9 (5)10 (5)19 (5)3 (5)1 (2)4 (3)30 (6)
 Pulmonary embolism2 (1)3 (2)5 (1)8 (2)
Cardiac disorders7 (4)10 (5)17 (5)4 (7)3 (6)7 (6)29 (6)
 Cardiac arrest5 (3)3 (2)8 (2)3 (5)1 (2)4 (4)12 (2)
 Acute myocardial infarction0 (0)3 (2)3 (1)3 (1)
Vascular disorders4 (2)8 (4)12 (3)25 (5)
 Shock1 (1)3 (2)4 (1)1 (2)1 (1)9 (2)
Infections and infestations4 (2)7 (4)11 (3)3 (5)1 (2)4 (4)26 (5)
 Septic shock4 (2)5 (3)9 (2)1 (2)1 (1)14 (3)
 Sepsis0 (0)3 (2)3 (1)7 (1)
General disorders and administration site conditions2 (1)8 (4)10 (3)15 (3)
 Multiple organ dysfunction syndrome2 (1)6 (3)8 (2)9 (2)
Renal and urinary disorders1 (1)7 (4)8 (2)16 (3)
 Acute kidney injury1 (1)4 (2)5 (1)13 (3)
Nervous system disorders0 (0)3 (2)3 (1)4 (1)
General disorders0 (0)3 (2)3 (1)3 (1)
  • CRP, C reactive protein.