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. Author manuscript; available in PMC: 2013 Oct 1.
Published in final edited form as: Clin Cancer Res. 2012 Jul 23;18(19):5179–5187. doi: 10.1158/1078-0432.CCR-12-0726

Table 2.

Results of 1000 simulated trials under true toxicity rates equal to 0.1, 0.17, 0.26, 0.4, 0.42, 0.45 for the 6 levels, respectively, and a target acceptable toxicity rate of 25%. Each error rate varied from 0 to 0.3 by increments of 0.05. Level -1: one level below level 1; NF: dose not found because level 1 was too toxic. Numbers in bold indicate true MTD.

% Trials selecting each dose Patients Treated DLTs Duration Sample
Size
Level NF −1 1 2 3 4 5 6 −1 1 2 3 4 5 6
accrual
rate:
1/mos
CRM
Error A: 0 5 24 43 21 5 2 16 28 32 17 5 2 5 (4,6) 19.9 20
0.05 3 22 41 23 8 3 14 26 33 18 7 3 5 (4,6) 19.9 20
0.10 4 20 42 23 8 4 14 26 31 18 7 3 5 (4,6) 19.8 20
0.15 2 15 38 27 12 6 13 23 30 20 9 4 5 (4,5) 20.2 20
0.20 1 15 35 28 13 7 11 23 30 21 10 6 4 (4,5) 19.8 20
0.25 1 12 32 30 15 9 11 21 29 21 12 6 4 (3,5) 20.2 20
0.30 1 7 28 32 18 # 10 19 27 23 13 8 4 (3,5) 19.8 20
3+3 1 8 25 31 27 7 1 1 31 30 21 9 2 0 3 (2,3) 15.1 15
2 7 21 32 27 8 3 1 30 30 22 10 3 0 3 (2,3) 15.7 15
0 6 19 30 32 9 3 1 28 29 23 12 3 1 3 (2,3) 15.6 15
1 8 16 31 28 11 4 2 27 28 23 11 4 1 3 (2,3) 16.0 15
1 7 15 25 31 13 7 2 27 26 22 14 5 2 3 (2,3) 16.9 15
1 6 13 25 30 14 8 4 25 26 23 14 6 3 3 (2,3) 17.0 18
0 5 13 24 29 17 7 6 25 25 22 15 6 3 3 (2,3) 17.6 18
accrual
rate: 3/mos
CRM 5 27 43 19 4 2 17 36 30 12 4 1 5 (3,6) 7.8 20
4 24 39 25 6 2 19 36 29 13 3 1 4 (3,5) 7.9 20
5 22 37 27 6 2 17 35 29 14 4 1 4 (3,5) 7.8 20
3 18 39 29 8 4 16 33 30 15 5 2 4 (3,5) 7.8 20
1 15 35 30 12 7 14 32 30 16 5 2 4 (3,5) 7.8 20
1 11 33 33 13 8 13 31 29 18 7 3 4 (3,5) 7.8 20
1 11 33 31 15 10 12 31 30 18 7 3 4 (3,5) (,) 7.9 20
3+3 1 8 25 31 27 7 1 1 31 30 21 9 2 0 3 (2,3) 5.6 15
2 7 21 32 27 8 3 1 30 30 22 10 3 0 3 (2,3) 5.8 15
0 6 19 30 32 9 3 1 28 29 23 12 3 1 3 (2,3) 5.7 15
1 8 16 31 28 11 4 2 28 28 23 11 4 1 3 (2,3) 5.9 15
1 7 15 25 31 13 7 2 27 26 22 14 5 2 3 (2,3) 6.2 15
1 6 13 25 30 14 8 4 25 26 23 14 6 2 3 (2,3) 6.3 9
0 5 13 24 29 17 7 6 25 26 22 15 6 3 3 (2,3) 6.4 18
accrual rate:
1/mos
CRM
Error B: 0 5 24 43 21 5 2 16 28 32 17 5 2 5 (4,6) 19.9 20
0.05 14 33 35 13 3 1 23 31 28 13 4 1 5 (4,6) 20.0 20
0.10 29 35 26 9 2 1 32 32 24 10 3 1 6 (5,7) 19.6 20
0.15 44 34 17 4 1 1 44 30 17 7 2 1 6 (5,7) 20.3 20
0.20 58 25 14 3 0 0 51 26 16 5 2 0 6 (6,8) 20.0 20
0.25 74 17 7 1 0 0 62 23 11 3 1 0 7 (6,8) 19.9 20
0.30 82 12 4 1 0 0 70 19 9 3 1 0 8 (7,9) 19.8 20
3+3 accrual rate:
1/mos
1 8 25 31 27 7 1 1 5 31 30 21 9 2 0 3 (2,3) 15.1 15
5 14 26 32 17 4 1 0 10 36 29 17 6 1 0 2 (2,3) 14.0 12
8 20 32 24 13 3 0 0 15 40 27 13 4 0 0 2 (2,3) 13.0 12
18 21 33 19 8 1 0 0 21 43 24 9 3 0 0 2 (2,3) 12.3 12
26 23 31 15 5 0 0 0 25 45 21 7 1 0 0 2 (2,3) 11.8 12
38 23 26 10 2 0 0 0 31 46 17 4 0 0 0 2 (2,3) 11.0 12
51 19 22 7 0 0 0 0 36 47 14 3 0 0 0 2 (2,3) 10.5 9
CRM accrual rate:
3/mos
5 27 43 19 4 2 17 36 30 12 4 1 5 (3,6) 7.8 20
12 38 34 13 3 0 25 38 25 9 3 1 5 (4,6) 7.8 20
27 38 27 6 1 0 34 37 21 6 1 0 5 (4,6) 7.8 20
45 32 18 5 1 0 45 33 16 4 1 0 6 (5,7) 7.8 20
58 29 11 2 0 0 51 31 14 3 0 0 6 (5,8) 7.7 20
74 19 6 0 0 0 61 26 11 2 0 0 7 (6,8) 7.6 20
85 12 3 0 0 0 69 23 7 1 0 0 8 (7,9) 7.6 20
3+3 accrual rate:
3/mos
1 8 25 31 27 7 1 1 5 31 30 21 9 2 0 3 (2,3) 5.6 15
5 14 26 32 17 4 1 0 10 36 29 17 6 1 0 2 (2,3) 5.3 12
8 20 32 24 13 3 0 0 15 40 27 13 4 0 0 2 (2,3) 4.9 12
18 21 33 19 8 1 0 0 21 43 24 9 3 0 0 2 (2,3) 4.6 12
26 23 31 15 5 0 0 0 25 45 21 7 1 0 0 2 (2,3) 4.5 12
38 23 26 10 2 0 0 0 31 46 17 4 0 0 0 2 (2,3) 4.2 12
51 19 22 7 0 0 0 0 36 47 14 3 0 0 0 2 (2,3) 4.0 9