Table 3 Treatment-related adverse events
SOC PT | Part 1 (n = 43) | Part 2 (n = 16) | ||
|---|---|---|---|---|
Grade 1–2 n (%) | Grade 3–4 n (%) | Grade 1–2 n (%) | Grade 3–4 n (%) | |
Blood and lymphatic system disorders | ||||
Anaemia | 6 (13.9) | 0 | 3 (18.8) | 0 |
Platelet count decreased | 3 (6.9) | 0 | 0 | 0 |
Cardiac disorders | ||||
Palpitations | 0 | 0 | 1 (6.3) | 0 |
Tachycardia | 0 | 0 | 1 (6.3) | 0 |
Gastrointestinal disorders | ||||
Nausea | 16 (37.2) | 0 | 6 (37.5) | 0 |
Diarrhoea | 14 (32.6) | 0 | 5 (31.3) | 0 |
Vomiting | 6 (13.9) | 0 | 4 (25.0) | 0 |
Constipation | 4 (9.3) | 0 | 3 (18.8) | 0 |
Abdominal pain | 2 (4.7) | 0 | 1 (6.3) | 0 |
Dyspepsia | 0 | 0 | 1 (6.3) | 0 |
Flatulence | 0 | 0 | 1 (6.3) | 0 |
General disorders and administration site conditions | ||||
Fatigue | 23 (53.5) | 1 (2.3) | 7 (43.8) | 0 |
Pyrexia | 4 (9.3) | 0 | 0 | 0 |
Mucositis | 3 (6.9) | 0 | 0 | 0 |
Chest pain | 0 | 1 (2.3) | 1 (6.3) | 0 |
Gait disturbance | 0 | 0 | 1 (6.3) | 0 |
Infections | ||||
Herpes zoster | 0 | 0 | 0 | 1 (6.3) |
Injury, poisoning and procedural complications | ||||
Infusion-related reaction | 15 (34.9) | 0 | 6 (37.5) | 0 |
Investigations | ||||
ALT increased | 4 (9.3) | 2 (4.7) | 2 (12.5) | 0 |
AST increased | 4 (9.3) | 1 (2.3) | 1 (6.3) | 1 (6.3) |
ALT and AST increased | 4 (9.3) | 2 (4.7) | 0 | 0 |
Blood ALP increased | 2 (4.7) | 0 | 0 | 0 |
Blood bilirubin increased | 2 (4.7) | 0 | 0 | 0 |
GGT increased | 0 | 1 (2.3) | 0 | 0 |
Hepatic enzyme increased | 0 | 0 | 0 | 1 (6.3) |
Metabolism and nutrition disorders | ||||
Hyperglycaemia | 3 (6.9) | 0 | 0 | 0 |
Decreased appetite | 2 (4.7) | 0 | 4 (25.0) | 0 |
Hypophosphatemia | 2 (4.7) | 0 | 0 | 0 |
Musculoskeletal and connective tissue disorders | ||||
Myalgia | 2 (4.7) | 0 | 0 | 0 |
Muscle spasms | 0 | 0 | 1 (6.3) | 0 |
Nervous system disorders | ||||
Dysgeusia | 7 (16.3) | 0 | 0 | 0 |
Headache | 4 (9.3) | 0 | 2 (12.5) | 0 |
Neuropathy peripheral | 4 (9.3) | 0 | 0 | 0 |
Lethargy | 3 (6.9) | 0 | 1 (6.3) | 0 |
Posterior reversible encephalopathy syndrome | 0 | 1 (2.3) | 0 | 0 |
Respiratory, thoracic and mediastinal disorders | ||||
Dyspnoea | 3 (6.9) | 0 | 1 (6.3) | 0 |
Throat irritation | 2 (4.7) | 0 | 0 | 0 |
Dyspnoea exertional | 0 | 0 | 1 (6.3) | 0 |
Dysphonia | 0 | 0 | 1 (6.3) | 0 |
Skin and subcutaneous tissue disorders | ||||
Palmar-plantar erythrodysesthesia syndrome | 2 (4.7) | 0 | 0 | 0 |
Rash | 0 | 0 | 1 (6.3) | 0 |
Vascular disorders | ||||
Flushing | 5 (11.6) | 0 | 0 | 0 |
Hypotension | 0 | 1 (2.3) | 0 | 0 |