. Author manuscript; available in PMC: 2018 Feb 7.

Published in final edited form as: J Biopharm Stat. 2017 Feb 7;27(3):495–506. doi: 10.1080/10543406.2017.1290650

Table 5.

Optimal indifference interval width δ and initial design D₀ using toxicity calibration scenarios based on an odds ratio of 2 in the proposed algorithm, target probability of DLT p = 0.20, K dose levels and sample size N.

	K	λ		N=25		N=30		N=35		N=40
			δ	D₀	δ	D₀	δ	D₀	δ	D₀
	4	1	0.04	(2,3,3,17)	0.04	(2,3,3,22)	0.04	(2,3,3,27)	0.04	(2,3,3,32)
			0.03	(2,2,3,18)	0.03	(2,2,3,23)
		2	0.04	(2,3,3,17)	0.04	(2,3,3,22)	0.04	(2,3,3,27)	0.04	(2,3,3,32)
			0.03	(2,2,3,18)	0.03	(2,2,3,23)
	5	1	0.04	(2,2,2,3,16)	0.04	(2,2,2,3,21)	0.04	(2,2,2,3,26)	0.04	(2,2,2,3,31)
			0.03	(2,2,2,2,17)	0.03	(2,2,2,2,22)	0.03	(2,2,2,2,27)	0.03	(2,2,2,2,32)
		2	0.04	(2,2,2,3,16)	0.04	(2,2,2,3,21)	0.04	(2,2,2,3,26)	0.04	(2,2,2,3,31)
			0.03	(2,2,2,2,17)	0.03	(2,2,2,2,22)	0.03	(2,2,2,2,27)	0.03	(2,2,2,2,32)
	6	1	0.03	(1,2,2,2,2,16)	0.03	(1,2,2,2,2,21)	0.03	(1,2,2,2,2,26)	0.03	(1,2,2,2,2,31)
			0.04	(2,2,2,2,3,14)	0.04	(2,2,2,2,3,19)	0.04	(2,2,2,2,3,24)	0.04	(2,2,2,2,3,29)
		2	0.03	(1,2,2,2,2,16)	0.03	(1,2,2,2,2,21)	0.03	(1,2,2,2,2,26)	0.03	(1,2,2,2,2,31)
			0.04	(2,2,2,2,3,14)	0.04	(2,2,2,2,3,19)	0.04	(2,2,2,2,3,24)	0.04	(2,2,2,2,3,29)
^a	7	1	0.03	(1,1,1,2,2,2,16)	0.03	(1,1,1,2,2,2,21)	0.03	(1,1,1,2,2,2,26)	0.03	(1,1,1,2,2,2,31)
^a		2	0.03	(1,1,1,2,2,2,16)	0.03	(1,1,1,2,2,2,21)	0.03	(1,1,1,2,2,2,26)	0.03	(1,1,1,2,2,2,31)

The additional designs yield average percentage of correct selection within 1 percentage point of the optimal indifference interval width δ and initial design D₀. λ = 1 and 2 imply that the numbers of patients reserved on the highest dose level K are 5 and 10, respectively.