Table 5.

Summary of discontinuation due to adverse events

Subject	Dose	Day last dosed	Reasons for withdrawal	Severity*
A	1600 mg	10	Abnormal liver function tests	Grade 1
B	1600 mg	20	Increased creatine phosphokinase	Grade 3†
C	2400 mg	26	Alopecia	Grade 2
D	3200 mg	10	Abnormal liver function tests	Grade 2 Grade 1
			Blood in stools	Grade 1
E	3200 mg	13	Abdominal pain	Grade 2
			Vision blurred	Grade 2
F	3200 mg	10	Abnormal liver function tests	Grade 2
G	3200 mg	15	Headache	Grade 2
H	Placebo	15	Headache	Grade 2

^*Severity of adverse events is based on NCI Common Toxicity Criteria version 2.0.

^†Please note the event was not symptomatic but classified into grade 3 according to the NCI CTC.