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Table 5 Empirical power and the percentage of trials stopping for futility and efficacy for sample size re-estimation using conditional power

From: Impact of misspecifying the distribution of a prognostic factor on power and sample size for testing treatment interactions in clinical trials

θ

Planned distribution of the prognostic factor

Planned n t

Empirical power

Percent stopping for futility

Percent stopping for efficacy

Misspecification of the prognostic factor: -5%

5

10%

1,418

0.7324

16.58%

5.76%

20%

798

0.8410

10.34%

11.76%

30%

608

0.8616

9.02%

13.72%

40%

532

0.8754

8.24%

15.42%

50%

512

0.8868

7.64%

16.22%

15

10%

178

0.7246

17.14%

7.90%

20%

100

0.8232

12.26%

11.82%

30%

78

0.8736

8.94%

14.76%

40%

68

0.8936

7.72%

15.80%

50%

64

0.9010

7.10%

16.38%

Misspecification of the prognostic factor: -15%

5

10%

1,418

--

--

--

20%

798

0.5614

26.06%

3.5%

30%

608

0.7536

15.46%

7.3%

40%

532

0.8304

10.72%

10.80%

50%

512

0.8750

8.34%

14.32%

15

10%

178

--

--

--

20%

100

0.6026

22.68%

4.96%

30%

78

0.7634

15.76%

8.50%

40%

68

0.8412

10.78%

11.86%

50%

64

0.8734

9.32%

14.76%

Misspecification of the prognostic factor: +5%

5

10%

1,418

0.9528

3.10%

27.44%

20%

798

0.9194

5.58%

20.94%

30%

608

0.9064

6.26%

18.36%

40%

532

0.8898

7.18%

17.16%

50%

512

0.8868

7.52%

16.02%

15

10%

178

0.9476

3.94%

29.36%

20%

100

0.9194

5.70%

21.78%

30%

78

0.9204

5.94%

20.38%

40%

68

0.9146

6.36%

18.28%

50%

64

0.9056

6.96%

15.88%

Misspecification of the prognostic factor: +15%

5

10%

1,418

0.9868

0.94%

45.24%

20%

798

0.9494

3.38%

27.26%

30%

608

0.9186

5.34%

20.84%

40%

532

0.8990

6.98%

17.12%

50%

512

0.8822

8.00%

14.30%

15

10%

178

0.9902

0.78%

49.94%

20%

100

0.9584

3.18%

29.86%

30%

78

0.9412

4.32%

22.32%

40%

68

0.9108

6.56%

17.12%

50%

64

0.8816

8.76%

13.84%

  1. The margin of error based on the 99% confidence interval is 0.015.