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Table 1 Sample size per arm necessary for a two-arm trial, for a fixed delta of 10 percentage points, a margin d of 2.5 or 5 percentage points, and Pmost at 80% or 85%. The tumour response rate with drug A varies between 20 and 80%

From: Sample size calculation in randomised phase II selection trials using a margin of practical equivalence

 

Margin d 2.5%

Margin d 5%

TRR drug A

TRR drug B

Pmost 80%

Pmost  85%

Pmost  80%

Pmost 85%

20%

10%

19

28

19

35

30%

20%

27

46

32

54

40%

30%

33

53

37

59

50%

40%

36

57

39

73

60%

50%

36

57

39

73

70%

60%

33

53

37

70

80%

70%

27

46

32

54