Table 2 Open in new tab Adverse events...

Variable	Arm A (n = 50), %	Arm B (n = 49), %
Haematological
White blood cell decreased	94	60	2	94	59	2
Anaemia	100	14	4	98	10	2
Platelet count decreased	100	8	2	94	8	6
Neutrophil count decreased	92	46	8	96	39	18
Non-haematological
Blood bilirubin increased	30	8	0	29	8	0
ALP increased	66	0	0	71	16	0
AST increased	88	12	2	78	27	2
ALT increased	94	14	0	80	18	4
Creatinine increased	8	2	0	14	0	0
Fatigue	66	8	—	65	4	—
Fever	18	0	0	24	0	0
Urticaria	8	0	—	14	0	—
Anorexia	88	16	0	76	4	0
Constipation	44	0	0	49	2	0
Diarrhoea	46	6	0	37	4	0
Nausea	80	8	—	63	2	—
Vomiting	50	2	0	33	4	0
Mucositis oral	12	0	0	14	0	0
Dysgeusia	34	—	—	24	—	—
Pneumonitis	6	0	4^a	4	2	0
Gastric/duodenal ulcer	6	6	0	8	4	0
Gastric/duodenal haemorrhage	10	8	2^a	12	6	0
Biliary infection	20	18	2^a	27	27	0

Variable	Arm A (n = 50), %	Arm B (n = 49), %
Haematological
White blood cell decreased	94	60	2	94	59	2
Anaemia	100	14	4	98	10	2
Platelet count decreased	100	8	2	94	8	6
Neutrophil count decreased	92	46	8	96	39	18
Non-haematological
Blood bilirubin increased	30	8	0	29	8	0
ALP increased	66	0	0	71	16	0
AST increased	88	12	2	78	27	2
ALT increased	94	14	0	80	18	4
Creatinine increased	8	2	0	14	0	0
Fatigue	66	8	—	65	4	—
Fever	18	0	0	24	0	0
Urticaria	8	0	—	14	0	—
Anorexia	88	16	0	76	4	0
Constipation	44	0	0	49	2	0
Diarrhoea	46	6	0	37	4	0
Nausea	80	8	—	63	2	—
Vomiting	50	2	0	33	4	0
Mucositis oral	12	0	0	14	0	0
Dysgeusia	34	—	—	24	—	—
Pneumonitis	6	0	4^a	4	2	0
Gastric/duodenal ulcer	6	6	0	8	4	0
Gastric/duodenal haemorrhage	10	8	2^a	12	6	0
Biliary infection	20	18	2^a	27	27	0

Table 2

Adverse events through all protocol treatment in the safety population (CTCAE version 4.0)

Variable	Arm A (n = 50), %			Arm B (n = 49), %
	All grade	Grade 3	Grade 4	All grade	Grade 3	Grade 4
Haematological
White blood cell decreased	94	60	2	94	59	2
Anaemia	100	14	4	98	10	2
Platelet count decreased	100	8	2	94	8	6
Neutrophil count decreased	92	46	8	96	39	18
Non-haematological
Blood bilirubin increased	30	8	0	29	8	0
ALP increased	66	0	0	71	16	0
AST increased	88	12	2	78	27	2
ALT increased	94	14	0	80	18	4
Creatinine increased	8	2	0	14	0	0
Fatigue	66	8	—	65	4	—
Fever	18	0	0	24	0	0
Urticaria	8	0	—	14	0	—
Anorexia	88	16	0	76	4	0
Constipation	44	0	0	49	2	0
Diarrhoea	46	6	0	37	4	0
Nausea	80	8	—	63	2	—
Vomiting	50	2	0	33	4	0
Mucositis oral	12	0	0	14	0	0
Dysgeusia	34	—	—	24	—	—
Pneumonitis	6	0	4^a	4	2	0
Gastric/duodenal ulcer	6	6	0	8	4	0
Gastric/duodenal haemorrhage	10	8	2^a	12	6	0
Biliary infection	20	18	2^a	27	27	0

Variable	Arm A (n = 50), %			Arm B (n = 49), %
	All grade	Grade 3	Grade 4	All grade	Grade 3	Grade 4
Haematological
White blood cell decreased	94	60	2	94	59	2
Anaemia	100	14	4	98	10	2
Platelet count decreased	100	8	2	94	8	6
Neutrophil count decreased	92	46	8	96	39	18
Non-haematological
Blood bilirubin increased	30	8	0	29	8	0
ALP increased	66	0	0	71	16	0
AST increased	88	12	2	78	27	2
ALT increased	94	14	0	80	18	4
Creatinine increased	8	2	0	14	0	0
Fatigue	66	8	—	65	4	—
Fever	18	0	0	24	0	0
Urticaria	8	0	—	14	0	—
Anorexia	88	16	0	76	4	0
Constipation	44	0	0	49	2	0
Diarrhoea	46	6	0	37	4	0
Nausea	80	8	—	63	2	—
Vomiting	50	2	0	33	4	0
Mucositis oral	12	0	0	14	0	0
Dysgeusia	34	—	—	24	—	—
Pneumonitis	6	0	4^a	4	2	0
Gastric/duodenal ulcer	6	6	0	8	4	0
Gastric/duodenal haemorrhage	10	8	2^a	12	6	0
Biliary infection	20	18	2^a	27	27	0

Events with a frequency of more than 10% or high-grade events (grades 3 and 4) are listed.

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CTCAE, Common Terminology Criteria for Adverse Events.

^aThree treatment-related deaths occurred in Arm A (pneumonitis, gastroduodenal haemorrhage, biliary infection).