Table 2.

Treatment-related adverse events.

	Stage 1 (N = 10)			Stage 2 (N = 20)
	Grade 1–2	Grade 3	Grade 4	Grade 1–2	Grade 3	Grade 4
Haematological
Neutropenia	6 (60%)	7 (70%)	0	10 (50%)	6 (30%)	2 (10%)
Febrile neutropenia	0	1 (10%)	0	0	0	0
Anaemia	10 (100%)	1 (10%)	0	17 (85%)	3 (15%)	0
Thrombocytopenia	7 (70%)	0	0	9 (45%)	2 (10%)	1 (5%)
Non-haematological
Fatigue	7 (70%)	0	0	18 (90%)	1 (5%)	0
Diarrhoea	6 (60%)	3 (30%)	0	13 (65%)	1 (5%)	0
Nausea	5 (50%)	0	0	18 (90%)	1 (5%)	0
Vomiting	4 (40%)	0	0	11 (55%)	1 (5%)	0
Anorexia	7 (70%)	1 (10%)	0	15 (75%)	0	0
Mucositis	7 (70%)	2 (20%)	0	8 (40%)	0	0
Peripheral sensory neuropathy	10 (100%)	2 (20%)	0	17 (85%)	0	0
Dizziness	2 (20%)	0	0	2 (10%)	0	0
Alopecia	3 (30%)	0	0	4 (20%)	0	0
Dyspnoea	3 (30%)	0	0	5 (25%)	0	0
Laryngitis	0	1 (10%)	0	0	0	0
Biochemical eventa
Increased alanine amino-transferase level	7 (70%)	3 (30%)	0	9 (45%)	0	0
Increased alkaline phosphatase level	3 (30%)	8 (80%)	1 (10%)	2 (10%)	1 (5%)	0
Increased ɣ-glutamyl-transferase level	1 (10%)	6 (60%)	2 (20%)	4 (20%)	3 (15%)	1 (5%)
Hypocalcemia	0	0	0	2 (10%)	1 (5%)	0
Hypomagnesaemia	0	0	0	2 (10%)	2 (10%)	0

Data are presented as the number of patients (N) (%). Grade 1 and 2 adverse events reported in at least 10% of patients and all grade 3 and 4 events are presented in this table. No treatment-related grade 5 events were occurred. Adverse events that occurred multiple times in an individual were counted only once.

^aIt was unclear whether these liver function abnormalities were related to the study treatment.