Table 3.
TEAE of any grade ≥15%, n (%) | Total (N = 114) |
---|---|
Fatigue | 65 (57·0) |
Nausea | 55 (48·2) |
Diarrhoea | 52 (45·6) |
Constipation | 30 (26·3) |
Decreased appetite | 28 (24·6) |
Cough | 27 (23·7) |
Pyrexia | 27 (23·7) |
Vomiting | 25 (21·9) |
Anaemia | 21 (18·4) |
Headache | 21 (18·4) |
Dizziness | 20 (17·5) |
Dyspepsia | 20 (17·5) |
ALT increased | 19 (16·7) |
Dyspnoea | 18 (15·8) |
Upper respiratory tract infection | 18 (15·8) |
SAE of any grade ≥2% | |
Dyspnoea | 5 (4·4) |
Acute kidney injury | 4 (3·5) |
Anaemia | 3 (2·6) |
Febrile neutropenia | 3 (2·6) |
Pneumonia | 3 (2·6) |
Laboratory abnormalities of any grade ≥20%: serum chemistry | |
Creatinine increased | 66 (57·9) |
ALT increased | 50 (43·9) |
AST increased | 41 (36·0) |
Hyperglycaemia | 37 (32·5) |
Alkaline phosphatase increased | 34 (29·8) |
Hypoalbuminaemia | 30 (26·3) |
Total bilirubin increased | 30 (26·3) |
Hyponatraemia | 28 (24·6) |
Indirect blood bilirubin increased | 23 (20·2) |
Laboratory abnormalities of any grade ≥20%: haematology | |
Anaemia | 42 (36·8) |
Neutropenia | 35 (30·7) |
Lymphocytes decreased | 34 (29·8) |
Leucocytes decreased | 33 (28·9) |
SAE, serious adverse event; TEAE, treatment‐emergent adverse event.