Table 2.
Summary of the most frequently reported serious adverse events during the study (in ≥3 of the total patients)
| System organ class/preferred term | Tomuzotuximab (N = 115), n (%) | Cetuximab (N = 122), n (%) | Total (N = 237), n (%) |
|---|---|---|---|
| Any serious adverse event | 70 (60.9) | 78 (63.9) | 148 (62.4) |
| Infections and infestations | 22 (19.1) | 26 (21.3) | 48 (20.3) |
| Pneumonia | 12 (10.4) | 9 (7.4) | 21 (8.9) |
| Sepsis | 3 (2.6) | 7 (5.7) | 10 (4.2) |
| Device-related infection | 5 (4.3) | 4 (3.3) | 9 (3.8) |
| Lung abscess | 0 | 3 (2.5) | 3 (1.3) |
| Blood and lymphatic system disorders | 20 (17.4) | 17 (13.9) | 37 (15.6) |
| Anemia | 9 (7.8) | 9 (7.4) | 18 (7.6) |
| Neutropenia | 8 (7.0) | 7 (5.7) | 15 (6.3) |
| Thrombocytopenia | 2 (1.7) | 4 (3.3) | 6 (2.5) |
| Febrile neutropenia | 3 (2.6) | 2 (1.6) | 5 (2.1) |
| Leukopenia | 1 (0.9) | 4 (3.3) | 5 (2.1) |
| Metabolism and nutrition disorders | 14 (12.2) | 18 (14.8) | 32 (13.5) |
| Dehydration | 4 (3.5) | 5 (4.1) | 9 (3.8) |
| Hypomagnesaemia | 4 (3.5) | 5 (4.1) | 9 (3.8) |
| Hypokalemia | 3 (2.6) | 4 (3.3) | 7 (3.0) |
| Decreased appetite | 2 (1.7) | 3 (2.5) | 5 (2.1) |
| General disorders and administration site conditions | 13 (11.3) | 14 (11.5) | 27 (11.4) |
| General physical health deterioration | 2 (1.7) | 2 (1.6) | 4 (1.7) |
| Device dislocation | 1 (0.9) | 2 (1.6) | 3 (1.3) |
| Fatigue | 2 (1.7) | 1 (0.8) | 3 (1.3) |
| Mucosal inflammation | 3 (2.6) | 0 | 3 (1.3) |
| Gastrointestinal disorders | 11 (9.6) | 9 (7.4) | 20 (8.4) |
| Diarrhea | 3 (2.6) | 2 (1.6) | 5 (2.1) |
| Nausea | 3 (2.6) | 2 (1.6) | 5 (2.1) |
| Vomiting | 2 (1.7) | 2 (1.6) | 4 (1.7) |
| Respiratory, thoracic, and mediastinal disorders | 9 (7.8) | 10 (8.2) | 19 (8.0) |
| Pulmonary embolism | 2 (1.7) | 3 (2.5) | 5 (2.1) |
| Nervous system disorders | 5 (4.3) | 8 (6.6) | 13 (5.5) |
| Cerebrovascular accident | 2 (1.7) | 1 (0.8) | 3 (1.3) |