Table 2.
Treatment-related AEs that occurred in ≥ 10% (all grades) or in ≥ 1% (grade 3/4) of patients (N = 74).
| Treatment-related AE | Events, n (%) | |
|---|---|---|
| All grades | Grade 3/4 | |
| Any related AE | 70 (94.6) | 22 (29.7) |
| Fatigue | 31 (41.9) | 7 (9.5) |
| Decreased appetite | 26 (35.1) | 0 |
| AEs related to drug administration | ||
| Injection-site erythema | 26 (35.1) | 0 |
| Injection-site pain | 24 (32.4) | 0 |
| Injection-site induration | 21 (28.4) | 0 |
| Injection-site pruritus | 15 (20.3) | 0 |
| Injection-site reaction | 10 (13.5) | 0 |
| Injection-site swelling | 10 (13.5) | 0 |
| Nausea | 23 (31.1) | 1 (1.4) |
| Diarrhoea | 19 (25.7) | 0 |
| Dysgeusia | 19 (25.7) | 0 |
| Vomiting | 15 (20.3) | 1 (1.4) |
| Anaemia | 12 (16.2) | 6 (8.1) |
| Malaise | 11 (14.9) | 0 |
| Thrombocytopenia | 9 (12.2) | 7 (9.5) |
| AEs related to liver enzymes and metabolism | ||
| Blood bilirubin increased | 9 (12.2) | 4 (5.4) |
| ALT increased | 4 (5.4) | 1 (1.4) |
| AST increased | 4 (5.4) | 1 (1.4) |
| Bilirubin conjugated increased | 3 (4.1) | 2 (2.7) |
| Hepatic enzyme increased | 1 (1.4) | 1 (1.4) |
| Hepatitis | 1(1.4) | 1 (1.4) |
| Abdominal pain | 3 (4.1) | 1 (1.4) |
| Hyperkalaemia | 3 (4.1) | 1 (1.4) |
| Platelet count decreased | 3 (4.1) | 1 (1.4) |
| Blood glucose increased | 2 (2.7) | 1 (1.4) |
| AEs related to dyspnoea | ||
| Dyspnoea exertional | 2 (2.7) | 1 (1.4) |
| Dyspnoea | 1 (1.4) | 1 (1.4) |
| Hypertension | 2 (2.7) | 1 (1.4) |
| Hyperuricemia | 2 (2.7) | 1 (1.4) |
| Cardiomyopathy | 1 (1.4) | 1 (1.4) |
| Cholestasis | 1 (1.4) | 1 (1.4) |
| Neutropenia | 1 (1.4) | 1 (1.4) |
| Peritoneal haemorrhage | 1 (1.4) | 1 (1.4) |
ALT alanine aminotransferase, AST aspartate aminotransferase.