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. 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 7.

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 = 0.33, 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 0.06 (1,1,2,21) 0.07 (1,2,2,25) 0.06 (1,1,2,31) 0.05 (1,1,2,36)
0.05 (1,1,2,21) 0.06 (1,1,2,26) 0.05 (1,1,2,31) 0.06 (1,1,2,36)
0.07 (1,2,2,20) 0.07 (1,2,2,25) 0.07 (1,2,2,35)
2 0.06 (1,1,2,21) 0.07 (1,2,2,25) 0.06 (1,1,2,31) 0.05 (1,1,2,36)
0.05 (1,1,2,21) 0.06 (1,1,2,26) 0.05 (1,1,2,31) 0.06 (1,1,2,36)
0.07 (1,2,2,20) 0.07 (1,2,2,30) 0.07 (1,2,2,35)
5 1 0.07 (1,1,2,2,19) 0.06 (1,1,1,2,25) 0.05 (1,1,1,1,31) 0.05 (1,1,1,1,36)
0.05 (1,1,1,1,21) 0.04 (1,1,1,1,26) 0.04 (1,1,1,1,31) 0.04 (1,1,1,1,36)
0.06 (1,1,1,2,20) 0.05 (1,1,1,1,26) 0.06 (1,1,1,2,30) 0.06 (1,1,1,2,35)
0.07 (1,1,2,2,24) 0.07 (1,1,2,2,29) 0.07 (1,1,2,2,34)
2 0.07 (1,1,2,2,19) 0.06 (1,1,1,2,25) 0.05 (1,1,1,1,31) 0.05 (1,1,1,1,36)
0.05 (1,1,1,1,21) 0.04 (1,1,1,1,26) 0.04 (1,1,1,1,31) 0.04 (1,1,1,1,36)
0.06 (1,1,1,2,20) 0.05 (1,1,1,1,26) 0.06 (1,1,1,2,30) 0.06 (1,1,1,2,35)
0.07 (1,1,2,2,24) 0.07 (1,1,2,2,29) 0.07 (1,1,2,2,34)
6 1 0.05 (1,1,1,1,1,20) 0.06 (1,1,1,1,2,24) 0.06 (1,1,1,1,2,29) 0.05 (1,1,1,1,1,35)
0.04 (1,1,1,1,1,20) 0.04 (1,1,1,1,1,25) 0.04 (1,1,1,1,1,30) 0.04 (1,1,1,1,1,35)
0.06 (1,1,1,1,2,19) 0.05 (1,1,1,1,1,25) 0.05 (1,1,1,1,1,30) 0.06 (1,1,1,1,2,34)
0.07 (1,1,1,2,2,18) 0.07 (1,1,1,2,2,23) 0.07 (1,1,1,2,2,28) 0.07 (1,1,1,2,2,33)
2 0.05 (1,1,1,1,1,20) 0.06 (1,1,1,1,2,24) 0.06 (1,1,1,1,2,29) 0.05 (1,1,1,1,1,35)
0.04 (1,1,1,1,1,20) 0.04 (1,1,1,1,1,25) 0.04 (1,1,1,1,1,30) .04 (1,1,1,1,1,35)
0.06 (1,1,1,1,2,19) 0.05 (1,1,1,1,1,25) 0.05 (1,1,1,1,1,31) 0.06 (1,1,1,1,2,34)
0.07 (1,1,1,2,2,18) 0.07 (1,1,1,2,2,23) 0.07 (1,1,1,2,2,28) 0.07 (1,1,1,2,2,33)
7 1 0.05 (1,1,1,1,1,1,19) 0.05 (1,1,1,1,1,1,24) 0.05 (1,1,1,1,1,1,29) 0.05 (1,1,1,1,1,1,34)
0.06 (1,1,1,1,1,2,18) 0.06 (1,1,1,1,1,2,23) 0.06 (1,1,1,1,1,2,28) 0.06 (1,1,1,1,1,2,33)
0.07 (1,1,1,1,1,2,18) 0.07 (1,1,1,1,1,2,23)
2 0.05 (1,1,1,1,1,1,19) 0.05 (1,1,1,1,1,1,24) 0.05 (1,1,1,1,1,1,29) 0.05 (1,1,1,1,1,1,34)
a 0.06 (1,1,1,1,1,2,18) 0.06 (1,1,1,1,1,2,23) 0.06 (1,1,1,1,1,2,28) 0.06 (1,1,1,1,1,2,33)
0.07 (1,1,1,1,1,2,18) 0.07 (1,1,1,1,1,2,23)
a

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 3 and 6, respectively.