Table 3 Summary of possibly, probably or definitely drug-related adverse events (CTC grades 3, 4 and 5)
P2A DL0 | P2A DL1 | P2A DL2 | P2A DL3 | P2A DL4 | P2B DL0 | P2B DL1 | P2B DL1a | P2B DL2 | P2B DL2a | P2B DL3 | P2A+P2B total | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
No. of patients | 3 | 6 | 3 | 14 | 7 | 3 | 3 | 1 | 14 | 1 | 3 | 58 |
Haematological toxicity | ||||||||||||
Neutropenia grade 3 | 2 (14%) | 1 (14%) | 1 (33%) | 1 (33%) | 3 (21%) | 2 (67%) | 10 (17%) | |||||
Neutropenia grade 4 | 1 (14%) | 3 (21%) | 1 (33%) | 5 (9%) | ||||||||
Leucocytopenia grade 3 | 2 (29%) | 1 (33%) | 1 (33%) | 1 (7%) | 1 (33%) | 6 (10%) | ||||||
Thrombocytopenia grade 3 | 2 (14%) | 1 (14%) | 2 (67%) | 3 (21%) | 2 (67%) | 10 (17%) | ||||||
Thrombocytopenia grade 4 | 1 (7%) | 1 (33%) | 2 (3%) | |||||||||
Anaemia grade 3 | 1 (14%) | 1 (33%) | 1 (7%) | 1 (100%) | 1 (33%) | 5 (9%) | ||||||
Haemolytic uraemic syndrome | 1 (7%) | 1 (2%) | ||||||||||
Lymphopenia grade 3 | 1 (7%) | 1 (2%) | ||||||||||
Lymphopenia grade 4 | 1 (7%) | 1 (2%) | ||||||||||
Pancitopenia grade 5 | 1 (33%) | 1 (2%) | ||||||||||
Biochemical toxicity | ||||||||||||
Elevated ALT grade 3 | 1 (7%) | 1 (7%) | 2 (3%) | |||||||||
Elevated AST grade 3 | 1 (7%) | 1 (2%) | ||||||||||
Hyperbilirubinemia grade 3 | 1 (7%) | 1 (2%) | ||||||||||
Hyperglycaemia grade 3 | 1 (14%) | 1 (2%) | ||||||||||
Hypokalemia grade 3 | 1 (33%) | 1 (2%) | ||||||||||
Increased lipase grade 4 | 1 (33%) | 1 (2%) | ||||||||||
Metabolic acidosis grade 3 | 1 (33%) | 1 (2%) | ||||||||||
Gastrointestinal disorders | ||||||||||||
Diarrhoea grade 3 | 1 (7%) | 1 (14%) | 1 (7%) | 3 (5%) | ||||||||
Abdominal pain grade 3 | 1 (7%) | 1 (2%) | ||||||||||
Other toxicity | ||||||||||||
Fatigue grade 3 | 1 (14%) | 1 (14%) | 2 (29%) | 2 (14%) | 1 (33%) | 7 (12%) | ||||||
Hypertension grade 3 | 2 (14%) | 1 (33%) | 1 (33%) | 2 (14%) | 6 (10%) | |||||||
Pneumothorax grade 3 | 1 (7%) | 1 (2%) | ||||||||||
Tumour haemorrage grade 3 | 1 (7%) | 1 (14%) | 2 (3%) | |||||||||
Insomnia grade 3 | 1 (7%) | 1 (2%) | ||||||||||
Urinary infection grade 3 | 1 (7%) | 1 (2%) | ||||||||||
Hand–foot syndrome grade 3 | 1 (14%) | 1 (2%) | ||||||||||
P2B DL1a and DL2a no related AE ⩾ grade 3 reported | MTD P2A | MTD P2B | ||||||||||
