Table 2.

Common Adverse Events (regardless of attribution) According to Dosing Cohorts Reported in ≥ 10% of Patients

Cohort Characteristic and Adverse Event (grade)	Cohort							% of Total
	I	II	III	IV	CD-I	V	CD-II
No. of patients	7	9	6	8	10	7	9
Dose	1.25 mg/kg/d	2.5 mg/kg/d	5.0 mg/kg/d	8.3 mg/kg/d	8.3 mg/kg/d	12.5 mg/kg/d	560 mg/d
Schedule*	28/7 days	28/7 days	28/7 days	28/7 days	Once daily	28/7 days	Once daily
Diarrhea
1-2	0	4	1	4	7	3	5	42.9
3-4	0	1	1	0	0	0	0	3.6
Nausea/vomiting
1-2	3	3	3	4	4	2	4	41.1
3-4	0	0	0	1	0	0	0	1.8
Constipation
1-2	1	0	2	2	1	1	1	14.3
3-4	0	0	0	0	0	0	0	0
Decreased appetite/dyspepsia
1-2	2	3	1	1	5	1	4	30.4
3-4	0	0	0	0	2	0	0	3.6
Fatigue
1-2	4	4	0	3	4	4	2	37.5
3-4	0	0	0	0	2	0	0	3.6
Insomnia
1-2	1	1	1	0	3	0	0	10.7
3-4	0	0	0	0	0	0	0	0
Headache
1-2	1	2	1	4	2	2	2	25
3-4	0	0	0	0	0	0	0	0
Muscle spasms/myalgia
1-2	2	3	2	3	4	3	4	37.5
3-4	0	0	0	0	0	0	0	0
Other pain
1-2	8	1	5	4	6	5	6	62.5
3-4	0	0	0	0	1	0	0	1.8
Pyrexia
1-2	1	1	2	1	3	2	2	21.4
3-4	0	0	0	1	0	0	0	1.8
Rash
1-2	0	1	0	3	3	1	1	16.1
3-4	0	0	0	0	0	0	0	0
Cough
1-2	3	0	3	2	3	3	4	32.1
3-4	0	0	0	0	0	0	0	0
Other respiratory
1-2	1	2	3	5	5	4	8	50
3-4	1	0	1	0	2	0	0	7.1
Arthralgia
1-2	1	1	2	0	3	2	0	16.1
3-4	0	0	0	0	0	0	0	0
Edema
1-2	5	2	1	1	4	2	1	28.6
3-4	0	0	0	0	0	0	0	0

Abbreviation: CD, continuous dosing.

^*28/7 days = patients receiving drug for 28 continuous days followed by 7 days off of drug.