. Author manuscript; available in PMC: 2012 Nov 1.

Published in final edited form as: J Neurooncol. 2011 May 6;105(2):375–381. doi: 10.1007/s11060-011-0602-9

Table 2.

Dose levels evaluated and summary of dose-limiting toxicities during the first cycle of therapy

	COL-3 treatment group (daily dose, mg/m²)

	−EIAD				+EIAD

	25	50	75	100	25	50	75	100
No. of patients evaluated^a	3	3	3	8	3	6	4	4
Dose-limiting toxicity	0	0	0	2	0	1^b	0	0
Hematologic toxicity (grade 4)	0	0	0	0	0	0	0	0
Anemia	0	0	0	0	0	0	0	0
Nonhematologic toxicity (grade 3/4/5)	0	0	0	2	0	1	0	0
Ataxia	0	0	0	0	0	0	0	0
CNS hemorrhage	0	0	0	0	0	1^b	0	0
Diarrhea	0	0	0	0	0	0	0	0
Fatigue	0	0	0	1	0	0	0	0
Hypokalemia	0	0	0	0	0	1^b	0	0
Myalgia	0	0	0	1	0	0	0	0
Photosensitivity	0	0	0	0	0	0	0	0

−EIAD patients not taking enzyme-inducing antiseizure drugs; +EIAD patients taking enzyme-inducing antiseizure drugs

Total number of patients enrolled at each dose level

These two events occurred in the same patient, and were unlikely to be related to study drug but were considered dose-limiting and counted as one toxicity