Table 1.

Adverse Events by Category and Dosage

Adverse Event	100 mg n (%)	250 mg n (%)	500 mg n (%)	1,000 mg n (%)	1,500 mg n (%)	2,000 mg n (%)
Total	0 (0)	2 (66.6)	1 (33.3)	3 (50.0)	2 (66.6)	6 (66.6)
Fatigue*	0 (0)	1 (33.3)	0 (0)	1 (16.6)	1 (33.3)	0 (0)
GI Symptoms†	0 (0)	0 (0)	1 (33.3)	1 (16.6)	2 (66.6)	4 (44.4)
Headache	0 (0)	1 (33.3)	0 (0)	1 (16.6)	1 (33.3)	1 (11.1)
Other‡	0 (0)	0 (0)	0 (0)	0 (0)	1 (33.3)	1 (11.1)

^*Fatigue includes: Difficulty Concentrating

^†GI Symptoms include: Eructation, Heartburn, and Indigestion

^‡Other includes: Decreased Heart Rate and Burning with Urination

^**National Cancer Institute, Common Toxicity Criteria v.2.0