TABLE 3.
Treatment-emergent adverse events (TEAEs) and serious TEAEs in the safety analysis set
|
Tozorakimab+SoC
(n=54) |
SoC
(n=44) |
|
| TEAEs | 39 (72.2) | 26 (59.1) |
| System organ class | ||
| Infections and infestations | 11 (20.4) | 11 (25.0) |
| Respiratory, thoracic and mediastinal disorders | 12 (22.2) | 9 (20.5) |
| Gastrointestinal disorders | 11 (20.4) | 7 (15.9) |
| Investigations | 11 (20.4) | 4 (9.1) |
| Nervous system disorders | 5 (9.3) | 8 (18.2) |
| Cardiac disorders | 7 (13.0) | 5 (11.4) |
| General disorders and administration site conditions | 2 (3.7) | 8 (18.2) |
| Metabolism and nutrition disorders | 4 (7.4) | 6 (13.6) |
| Psychiatric disorders | 4 (7.4) | 5 (11.4) |
| Skin and subcutaneous tissue disorders | 5 (9.3) | 3 (6.8) |
| Musculoskeletal and connective tissue disorders | 4 (7.4) | 4 (9.1) |
| Renal and urinary disorders | 5 (9.3) | 1 (2.3) |
| Preferred terms occurring in three or more patients in either arm | ||
| Pulmonary embolism | 3 (5.6) | 5 (11.4) |
| Subcutaneous emphysema | 0 (0.0) | 3 (6.8) |
| Atrial fibrillation | 2 (3.7) | 4 (9.1) |
| Delirium | 2 (3.7) | 3 (6.8) |
| Dyspnoea | 4 (7.4) | 2 (4.5) |
| Epistaxis | 5 (9.3) | 0 (0.0) |
| Oral candidiasis | 1 (1.9) | 4 (9.1) |
| Constipation | 4 (7.4) | 0 (0.0) |
| Diarrhoea | 1 (1.9) | 3 (6.8) |
| Fall | 3 (5.6) | 1 (2.3) |
| Pneumonia | 1 (1.9) | 3 (6.8) |
| Increased alanine aminotransferase | 3 (5.6) | 0 (0.0) |
| Serious TEAEs occurring in two or more patients in either arm | ||
| Patients with serious TEAEs | 14 (25.9) | 10 (22.7) |
| Pulmonary embolism | 2 (3.7) | 3 (6.8) |
| Dyspnoea | 3 (5.6) | 0 (0.0) |
| Sepsis | 2 (3.7) | 1 (2.3) |
| Acute myocardial infarction | 2 (3.7) | 0 (0.0) |
| COVID-19 | 2 (3.7) | 0 (0.0) |
| Pneumonia | 1 (1.9) | 1 (2.3) |
| TEAEs leading to death | ||
| Patients with TEAEs leading to death | 2 (3.7) | 4 (9.1) |
| Acute respiratory distress syndrome | 0 (0.0) | 1 (2.3) |
| Blood culture positive | 0 (0.0) | 1 (2.3) |
| Carotid artery occlusion | 0 (0.0) | 1 (2.3) |
| Catheter site haemorrhage | 1 (1.9) | 0 (0.0) |
| Cerebral artery occlusion | 0 (0.0) | 1 (2.3) |
| Cerebral haemorrhage | 1 (1.9) | 0 (0.0) |
| Cerebral infarction | 0 (0.0) | 1 (2.3) |
| General physical health deterioration | 0 (0.0) | 1 (2.3) |
| Klebsiella infection | 1 (1.9) | 0 (0.0) |
| Multiple organ dysfunction syndrome | 0 (0.0) | 1 (2.3) |
| Pulmonary embolism | 0 (0.0) | 1 (2.3) |
| Sepsis | 1 (1.9) | 0 (0.0) |
| Bacterial superinfection | 0 (0.0) | 1 (2.3) |
Data are presented as n (%). SoC: standard of care; COVID-19: coronavirus disease 2019.