Most common grade≥3 adverse events (overall incidence ≥1.0%)
| System organ class preferred term n (%) | CRP <150 mg/L | CRP ≥150 mg/L | Overall | ||||
| Lenzilumab (n=181) | Placebo (n=193) | Total (n=374) | Lenzilumab (n=59) | Placebo (n=50) | Total (n=109) | Total (n=512) | |
| Any AE ≥grade 3 | 32 (17) | 54 (28) | 86 (23) | 24 (41) | 16 (32) | 40 (37) | 152 (30) |
| Respiratory, thoracic and mediastinal disorders | 30 (17) | 48 (25) | 78 (21) | 23 (39) | 15 (30) | 38 (35) | 135 (26) |
| Respiratory failure | 9 (5) | 22 (11) | 31 (8) | – | – | – | 55 (11) |
| Acute respiratory failure | 8 (4) | 15 (8) | 23 (6) | 6 (10) | 6 (12) | 12 (11) | 40 (8) |
| Hypoxia | 9 (5) | 10 (5) | 19 (5) | 3 (5) | 1 (2) | 4 (3) | 30 (6) |
| Pulmonary embolism | 2 (1) | 3 (2) | 5 (1) | – | – | – | 8 (2) |
| Cardiac disorders | 7 (4) | 10 (5) | 17 (5) | 4 (7) | 3 (6) | 7 (6) | 29 (6) |
| Cardiac arrest | 5 (3) | 3 (2) | 8 (2) | 3 (5) | 1 (2) | 4 (4) | 12 (2) |
| Acute myocardial infarction | 0 (0) | 3 (2) | 3 (1) | – | – | – | 3 (1) |
| Vascular disorders | 4 (2) | 8 (4) | 12 (3) | – | – | – | 25 (5) |
| Shock | 1 (1) | 3 (2) | 4 (1) | – | 1 (2) | 1 (1) | 9 (2) |
| Infections and infestations | 4 (2) | 7 (4) | 11 (3) | 3 (5) | 1 (2) | 4 (4) | 26 (5) |
| Septic shock | 4 (2) | 5 (3) | 9 (2) | – | 1 (2) | 1 (1) | 14 (3) |
| Sepsis | 0 (0) | 3 (2) | 3 (1) | – | – | – | 7 (1) |
| General disorders and administration site conditions | 2 (1) | 8 (4) | 10 (3) | – | – | – | 15 (3) |
| Multiple organ dysfunction syndrome | 2 (1) | 6 (3) | 8 (2) | – | – | – | 9 (2) |
| Renal and urinary disorders | 1 (1) | 7 (4) | 8 (2) | – | – | – | 16 (3) |
| Acute kidney injury | 1 (1) | 4 (2) | 5 (1) | – | – | – | 13 (3) |
| Nervous system disorders | 0 (0) | 3 (2) | 3 (1) | – | – | – | 4 (1) |
| General disorders | 0 (0) | 3 (2) | 3 (1) | – | – | – | 3 (1) |
CRP, C reactive protein.