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Table 5 Simulation results for TITE-PK, B-CRM, and BLRM-MAP in Scenarios 7-13

From: Phase I dose-escalation oncology trials with sequential multiple schedules

  Scenario
  7 8 9 10 11 12 13
Probability of selecting MTD in the targeted toxicity interval
TITE-PK 0.90 0.70 0.94 0.84 0.62 n/a 0.17
B-CRM 0.83 0.50 0.64 0.60 0.52 n/a 0.77
BLRM MAP 0.95 0.56 0.77 0.68 0.46 n/a 0.55
Probability of selecting MTD in the overdosing interval
TITE-PK n/a 0.22 0.05 0.02 0.37 0.02 n/a
B-CRM n/a 0.38 0.08 0.00 0.28 0.25 n/a
BLRM MAP n/a 0.40 0.21 0.10 0.41 0.03 n/a
Probability of selecting no combination as MTD
TITE-PK 0.00 0.02 0.01 0.14 0.00 0.98 0.15
B-CRM 0.00 0.02 0.02 0.28 0.20 0.75 0.00
BLRM MAP 0.00 0.02 0.02 0.22 0.12 0.97 0.01
Mean number of patients enrolled
TITE-PK 21.7 21.7 21.4 19.4 21.8 3.7 19.7
B-CRM 21.0 21.0 21.0 18.0 19.0 9.0 21.1
BLRM MAP 21.5 23.6 21.6 20.0 22.8 4.8 23.4
Proportion of patients enrolled in the overdosing interval
TITE-PK n/a 0.39 0.17 0.12 0.61 1.00 n/a
B-CRM n/a 0.46 0.15 0.06 0.72 1.00 n/a
BLRM MAP n/a 0.59 0.40 0.26 0.70 1.00 n/a
Mean number of DLT observed
TITE-PK 5.3 8.2 6.2 7.5 10.2 1.8 2.4
B-CRM 4.5 7.0 7.3 7.5 8.5 4.0 3.0
BLRM MAP 5.7 9.7 7.7 8.2 11.1 2.4 3.9