TABLE 2.
Adverse events
| Part 1 | Part 2 | |||||
| AE | Safety population | Age 70–79 years | Safety population | |||
| Otilimab (n=397) | Placebo (n=396) | Otilimab (n=89) | Placebo (n=91) | Otilimab (n=174) | Placebo (n=173) | |
| Any AE | ||||||
| Patients with ≥1 event | 274 (69) | 265 (67) | 73 (82) | 68 (75) | 140 (80) | 133 (77) |
| Any SAE | ||||||
| Patients with ≥1 event | 124 (31) | 147 (37) | 33 (37) | 49 (54) | 90 (52) | 90 (52) |
| Most common AEs ≥5% in any group | ||||||
| Constipation | 39 (10) | 35 (9) | 16 (18) | 14 (15) | 16 (9) | 15 (9) |
| Pneumonia | 43 (11) | 29 (7) | 13 (15) | 11 (12) | 12 (7) | 17 (10) |
| Acute kidney injury | 23 (6) | 25 (6) | 8 (9) | 11 (12) | 14 (8) | 12 (7) |
| Anaemia | 18 (5) | 22 (6) | 5 (6) | 8 (9) | 11 (6) | 10 (6) |
| Respiratory failure | 19 (5) | 21 (5) | 6 (7) | 9 (10) | 7 (4) | 8 (5) |
| Hypotension | 14 (4) | 16 (4) | 1 (1) | 6 (7) | 10 (6) | 13 (8) |
| Atrial fibrillation | 12 (3) | 18 (5) | 5 (6) | 9 (10) | 9 (5) | 12 (7) |
| Septic shock | 18 (5) | 16 (4) | 4 (4) | 2 (2) | 10 (6) | 6 (3) |
| Pulmonary embolism | 13 (3) | 25 (6) | 2 (2) | 9 (10) | 3 (2) | 7 (4) |
| Hypoxaemia | 10 (3) | 13 (3) | 1 (1) | 8 (9) | 10 (6) | 12 (7) |
| MODS | 12 (3) | 16 (4) | 3 (3) | 5 (5) | 6 (3) | 11 (6) |
| Hypokalaemia | 15 (4) | 16 (4) | 7 (8) | 6 (7) | 8 (5) | 4 (2) |
| Diarrhoea | 15 (4) | 18 (5) | 4 (4) | 6 (7) | 4 (2) | 5 (3) |
| UTI | 13 (3) | 14 (4) | 3 (3) | 5 (5) | 5 (3) | 10 (6) |
| Pneumothorax | 17 (4) | 15 (4) | 3 (3) | 6 (7) | 6 (3) | 3 (2) |
| Pyrexia | 20 (5) | 15 (4) | 3 (3) | 6 (7) | 1 (<1) | 4 (2) |
| Hyperglycaemia | 12 (3) | 14 (4) | 4 (4) | 3 (3) | 10 (6) | 4 (2) |
| Delirium | 17 (4) | 17 (4) | 4 (4) | 5 (5) | 3 (2) | 2 (1) |
| Hyperkalaemia | 17 (4) | 13 (3) | 5 (6) | 7 (8) | 4 (2) | 4 (2) |
| Hypertension | 17 (4) | 10 (3) | 6 (7) | 3 (3) | 6 (3) | 5 (3) |
| Acute respiratory failure | 10 (3) | 11 (3) | 5 (6) | 3 (3) | 6 (3) | 9 (5) |
| Hepatocellular injury | 6 (2) | 5 (1) | 5 (6) | 1 (1) | 14 (9) | 10 (6) |
| Hypernatraemia | 20 (5) | 10 (3) | 2 (2) | 6 (7) | 3 (2) | 1 (<1) |
| Insomnia | 12 (3) | 5 (1) | 3 (3) | 2 (2) | 8 (5) | 7 (4) |
| Sepsis | 7 (2) | 12 (3) | 1 (1) | 6 (7) | 6 (3) | 3 (2) |
| Decubitus ulcer | 16 (4) | 9 (2) | 8 (9) | 3 (3) | 0 | 2 (1) |
| Fluid overload | 1 (<1) | 2 (<1) | 0 | 1 (1) | 9 (5) | 5 (3) |
| Most common SAEs ≥5% any group | ||||||
| Respiratory failure | 17 (4) | 18 (5) | 6 (7) | 8 (9) | 6 (3) | 8 (5) |
| MODS | 12 (3) | 15 (4) | 3 (3) | 5 (5) | 6 (3) | 8 (5) |
| Septic shock | 14 (4) | 13 (3) | 4 (4) | 2 (2) | 8 (5) | 5 (3) |
| Acute respiratory failure | 9 (2) | 10 (3) | 5 (6) | 3 (3) | 6 (3) | 9 (5) |
| Pneumonia | 7 (2) | 9 (2) | 1 (1) | 5 (5) | 6 (3) | 5 (3) |
| COVID-19# | 3 (<1) | 5 (1) | 1 (1) | 1 (1) | 6 (3) | 9 (5) |
| Pulmonary embolism | 6 (2) | 11 (3) | 2 (2) | 5 (5) | 1 (<1) | 3 (2) |
| Patients with AEs of special interest | ||||||
| Serious infections | 50 (13) | 58 (15) | 12 (13) | 17 (19) | 37 (21) | 29 (17) |
| Cytokine release syndrome | 0 | 2 (<1) | 0 | 1 (1) | 3 (2) | 1 (<1) |
| Serious hypersensitivity reactions | 1 (<1) | 1 (<1) | 1 (1) | 0 | 0 | 0 |
| Infusion site reactions | 1 (<1) | 1 (<1) | 1 (1) | 0 | 0 | 0 |
| Neutropaenia | 1 (<1) | 0 | 0 | 0 | 0 | 0 |
Data are presented as n (%). AE: adverse event; SAE: serious adverse event; MODS: multiple organ dysfunction syndrome; UTI: urinary tract infection. #: COVID-19, as per protocol, was only to be reported as an AE if the signs and symptoms of COVID-19 were more severe than expected.