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Table 2 TTP and RR Thresholds Generated with Larger N (1-beta = 0.8, alpha = 0.05, censoring 0.05)

From: Stopping rules employing response rates, time to progression, and early progressive disease for phase II oncology trials

Response Time to Progression Study Size Stage 1 Drug Rejection Stage 2 Drug Acceptance Power Alpha Error ENnul
/PESnul 		ENalt
/PESalt
r nul r alt ttp nul ttp alt n 1 n 2 r 1 epd r 1+r 2 ttp     
0.05 0.2 3 6 30 15 ≤ 2 ≥ 8 ≥ 7 ≥ 5 0.863 0.015 36.6/0.56 44.5/0.04
0.05 0.2 3 7 30 15 ≤ 2 ≥ 7 ≥ 7 ≥ 6 0.849 0.008 35.0/0.67 44.4/0.04
0.05 0.2 4 7 30 15 ≤ 2 ≥ 7 ≥ 7 ≥ 6 0.85 0.037 38.3/0.45 44.4/0.04
0.05 0.2 4 8 30 15 ≤ 2 ≥ 7 ≥ 7 ≥ 6.75 0.864 0.014 38.3/0.44 44.6/0.03
0.05 0.2 5 8 30 30 ≤ 2 ≥ 6 ≥ 9 ≥ 6.75 0.874 0.06 47.7/0.41 58.5/0.05
0.05 0.2 6 9 30 50 ≤ 2 ≥ 5 ≥ 13 ≥ 7.75 0.84 0.063 58.4/0.43 76.5/0.07
0.2 0.4 5 8 30 30 ≤ 6 ≥ 6 ≥ 20 ≥ 6.75 0.872 0.075 50.8/0.31 58.5/0.05
0.2 0.4 5 9 30 40 ≤ 7 ≥ 6 ≥ 23 ≥ 7.5 0.888 0.019 54.5/0.39 68.2/0.05
0.3 0.5 5 8 30 50 ≤ 7 ≥ 6 ≥ 34 ≥ 6.75 0.888 0.053 65.2/0.3 77.1/0.06
0.3 0.5 6 9 30 70 ≤ 9 ≥ 5 ≥ 43 ≥ 7.5 0.864 0.073 72.9/0.39 93.2/0.1
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BMC Medical Research Methodology

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