Table 3.

Treatment-emergent adverse events during study treatment period (safety analysis set)

Adverse event	All grades	Grade 3	Grade 4
Haematological
Neutrophil count decreased	36 (65.5%)	17 (30.9%)	9 (16.4%)
Platelet count decreased	13 (23.6%)	0	0
Anaemia	9 (16.4%)	2 (3.6%)	0
White blood cell count decreased	7 (12.7%)	1 (1.8%)	1 (1.8%)
Non-haematological
Stomatitis	39 (70.9%)	5 (9.1%)	0
Dermatitis acneiform	34 (61.8%)	5 (9.1%)	0
Decreased appetite	30 (54.5%)	1 (1.8%)	0
Fatigue	27 (49.1%)	2 (3.6%)	0
Dry skin	27 (49.1%)	2 (3.6%)	0
Nausea	23 (41.8%)	1 (1.8%)	0
Paronychia	23 (41.8%)	0	0
Diarrhoea	17 (30.9%)	1 (1.8%)	0
Palmar-plantar erythrodysaesthesia syndrome	14 (25.5%)	1 (1.8%)	0
Platelet count decreased	13 (23.6%)	0	0
Hypomagnesaemia	12 (21.8%)	2 (3.6%)	0
Dysgeusia	12 (21.8%)	0	0
Peripheral sensory neuropathy	11 (20.0%)	2 (3.6%)	0
Rash	11 (20.0%)	1 (1.8%)	0
Malaise	10 (18.2%)	0	0
Vomiting	9 (16.4%)	1 (1.8%)	0
Pyrexia	9 (16.4%)	0	0
Pruritus	9 (16.4%)	0	0
Febrile neutropenia	6 (10.9%)	6 (10.9%)	0
Abdominal pain	6 (10.9%)	0	0

Data are n (%). The safety population includes all enrolled patients who received at least one dose of study treatment (n = 55). No treatment-related deaths occurred