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Table 1 TTP and RR Thresholds Generated with fixed N while varying H nul and H alt (1-beta = 0.8, alpha = 0.05, censoring 0.05, n1 = 15, n2 = 15)

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

Response Time to Progression Stage 1 Drug Rejection Stage 2 Drug Acceptance Power Alpha Error ENnul
/PESnul
ENalt
/PESalt
r nul r alt ttp nul ttp alt r 1 epd r 1+r 2 ttp     
0.05 0.2 3 6 ≤ 0 ≥ 5 ≥ 5 ≥ 5.25 0.815 0.035 26.8/0.21 29.7/0.02
0.05 0.2 3 7 ≤ 0 ≥ 5 ≥ 5 ≥ 6 0.828 0.02 26.8/0.22 29.8/0.01
0.05 0.2 4 7 ≤ -1 ≥ 16 ≥ 5 ≥ 6.25 0.821 0.074 30/0 30/0
0.05 0.2 4 8 ≤ 0 ≥ 4 ≥ 5 ≥ 7 0.812 0.035 26.8/0.21 29.6/0.02
0.05 0.2 5 8 ≤ 0 ≥ 9 ≥ 5 ≥ 7 0.825 0.15 29.99†/
0.0002
29.99†/
0.0005
0.05 0.2 6 9 ≤ 0 ≥ 10 ≥ 5 ≥ 8 0.816 0.2 29.99/
0.00001
29.99/
0.0001
0.1 0.3 3 7 ≤ 2 ≥ 5 ≥ 7 ≥ 6 0.854 0.03 24.4/0.37 29.5/0.03
0.1 0.3 4 7 ≤ 2 ≥ 4 ≥ 7 ≥ 6 0.829 0.09 28.9/0.38 24.4/0.07
0.1 0.3 4 8 ≤ 1 ≥ 4 ≥ 7 ≥ 6.75 0.86 0.055 26.2/0.25 29.6/0.03
0.2 0.4 5 8 ≤ 1 ≥ 7 ≥ 10 ≥ 6.75 0.867 0.23 29.97/
0.002
29.99/
0.0004
0.2 0.4 5 9 ≤ 3 ≥ 3 ≥ 10 ≥ 7.5 0.813 0.13 24.6/0.36 28.6/0.09
0.3 0.5 5 8 ≤ 4 ≥ 3 ≥ 12 ≥ 6.75 0.828 0.29 25.7/0.28 28.4/0.1
0.3 0.5 6 9 ≤ 4 ≥ 3 ≥ 12 ≥ 7.5 0.843 0.35 26.7/0.22 28.7/0.09
  1. †Truncated, not rounded, value.
  2. ENnul = expected number of patients accrued if a drug meets the criteria of the null hypothesis
  3. ENalt = expected number of patients accrued if a drug meets the criteria of the alternate hypothesis
  4. PESnul = probability of stopping the trial after stage I if a drug meets the criteria of the null hypothesis
  5. PESalt = probability of stopping the trial after stage I if a drug meets the criteria of the alternate hypothesis