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. Author manuscript; available in PMC: 2024 Jun 1.
Published in final edited form as: Clin Trials. 2024 Apr 9;21(3):322–330. doi: 10.1177/17407745231221152

Table 3.

Simulations results for the idelalisib example: percent of recommendations of each dose level (D1 to D5), estimated over 10000 simulated trials, with a 4-week or 16-week observation window for toxicity, a total sample size of 60 patients, an accrual rate of 2 patients per month.

Hazard D1 D2 D3 D4 D5 Duration

 16-week obs. window (8 patients per obs.window)

Constant True Probability of Toxicity 0.10 0.25 0.45 0.60 0.75
% recommended by TITE-CRM 10 82 8 0 0 136 weeks
% recommended by TITE-BOIN 12 82 6 0 0 161 weeks

 4 week obs. window (2 patients per obs.window)

Decreasing True Probability of Toxicity 0.077 0.196 0.364 0.501 0.650
% recommended by TITE-CRM 1 65 34 0 0 122 weeks
% recommended by TITE-BOIN 3 69 27 0 0 131 weeks
Decreasing True Probability of Toxicity 0.056 0.147 0.281 0.396 0.534
% recommended by TITE-CRM 0 24 68 8 0 122 weeks
% recommended by TITE-BOIN 0 32 60 8 0 131 weeks
Constant True Probability of Toxicity 0.026 0.069 0.139 0.205 0.293
% recommended by TITE-CRM 0 0 7 47 45 122 weeks
% recommended by TITE-BOIN 0 1 12 44 43 131 weeks