Table II.

Report of the most common grade 3–4 CTCAE drug-related adverse events and death on study.

	Arm A grade 3	Arm A grade 4	Arm A death on study	Arm B grade 3	Arm B grade 4	Arm-B death on study
Haematological toxicities
Anaemia	12 (50%)	4 (17%)		15 (65%)	2 (9%)
Thrombocytopenia	8 (33%)	15 (63%)		3 (13%)	14 (61%)
Neutropenia	2 (8%)	22 (92%)		2 (9%)	16 (70%)
Non-haematological toxicities	11 (48%)	2 (8%)		11 (48%)	3 (13%)
Fatigue/asthenia	1 (4%)			3 (13%)	1 (4%)
Joint/muscle pain/weakness	1 (4%)			4 (18%)	1 (4%)
Nausea/vomiting	3 (12%)			2 (9%)
Infections including aplastic fever	10 (42%)	1 (4%)	1 (4%)	7 (30%)	4 (18%)	6 (26%)
Hyponatraemia	0			3 (13%)
Hypokalaemia	2 (8%)			1 (4%)
Ischaemia						1 (4%)

Results are presented as number (percentage). Patients may have had more than one adverse event. All adverse events were evaluated according to CTCAE (Common Terminology Criteria for Adverse Events) v3 definitions (http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf). All adverse events with a frequency of 5% or more in at least one arm are listed.