Table 2.

Adverse events (all grades) by treatment arm

	Number of patients (%)
	DD/DI arm (N = 86)								HDI arm (N = 80)
Event	Grade 1		Grade 2		Grade 3		Grade 4		Grade 1		Grade 2		Grade 3		Grade 4
Flu-like symptoms
Fatigue	19	(22)	26	(30)	25	(29)	0		14	(17)	27	(34)	19	(24)	3	(4)
Fever	28	(33)	33	(38)	7	(8)	0		25	(31)	23	(29)	8	(10)	1	(1)
Rigors/chills	15	(17)	5	(6)	0		0		12	(15)	3	(4)	3	(4)	0
Arthralgia/myalgia	26	(30)	17	(20)	1	(1)	0		29	(36)	12	(15)	3	(4)	1	(1)
Sweating	8	(9)	3	(3)	0		0		8	(10)	1	(1)	1	(1)	0
Gastrointestinal
Nausea/vomiting	32	(37)	12	(14)	2	(2)	0		27	(34)	12	(15)	1	(1)	0
Constipation	13	(15)	5	(6)	0		0		9	(11)	3	(4)	0		0
Diarrhea	11	(13)	1	(1)	0		0		5	(6)	1	(1)	1	(1)	1	(1)
Anorexia	30	(35)	10	(12)	3	(3)	0		14	(17)	12	(15)	6	(7)	0
Hematological
Leukopenia	13	(15)	32	(37)	21	(24)	0		28	(35)	25	(31)	7	(9)	0
Anemia	12	(14)	0		1	(1)	0		16	(20)	3	(4)	0		0
Granulocytopenia	7	(8)	21	(24)	31	(36)	7	(8)	13	(16)	23	(29)	21	(26)	2	(2)
Platelets	11	(13)	1	(1)	3	(3)	1	(1)	16	(20)	5	(6)	0		0
Hemorrhage	2	(2)	4	(5)	0		0		1	(1)	1	(1)	0		0
Hepatic function
Bilirubin	3	(3)	2	(2)	0		0		6	(7)	0		0		0
SGOT/SGPT	16	(19)	11	(13)	18	(21)	15	(17)	21	(26)	24	(30)	18	(22)	3	(4)
Alkaline phosphatase	8	(9)	2	(2)	0		0		8	(10)	3	(4)	0		0
Liver dysfunction	0		2	(2)	1	(1)	0		3	(4)	1	(1)	1	(1)	0
Neurologic
Depression/anxiety	19	(22)	14	(16)	7	(8)	0		20	(25)	12	(15)	12	(15)	1	(1)
Cognitive disturbance	10	(12)	10	(12)	4	(5)	0		10	(12)	7	(9)	2	(2)	0
Cardiovascular
Hypertension	6	(7)	1	(1)	0		0		2	(2)	1	(1)	2	(2)	0
Hypotension	1	(1)	1	(1)	0		0		5	(6)	4	(5)	0		0
Ritmo	0		2	(2)	0		0		1	(1)	1	(1)	0		0
Cardiac dysfunction	6	(7)	4	(5)	0		0		7	(9)	6	(7)	2	(2)	1	(1)
Pulmonary
Dyspnea	8	(9)	3	(3)	0		0		13	(16)	4	(5)	0		0
Cough	7	(8)	1	(1)	0		0		13	(16)	1	(1)	0		0
Dermatology
Skin	15	(17)	7	(8)	4	(5)	0		15	(19)	11	(14)	2	(2)	1	(1)
Local	1	(1)	0		1	(1)	0		5	(6)	1	(1)	1	(1)	0
Metabolic
Hyperglycaemia	7	(8)	3	(3)	3	(3)	0		5	(6)	3	(4)	0		0
Hypoglycaemia	1	(1)	2	(2)	4	(5)	2	(2)	1	(1)	3	(4)	0		1	(1)