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Table 3 Power (%) to detect a difference of effectiveness between PI-A and PI-B according to the study design and the effectiveness of PI-B ( ϵ B ), assuming ϵ A = 0.999 and a limit of detection (“ML data”)

From: Clinical trial simulation to evaluate power to compare the antiviral effectiveness of two hepatitis C protease inhibitors using nonlinear mixed effect models: a viral kinetic approach

 

ϵ B

0.998

0.995

0.990

0.998

0.995

0.990

0.998

0.995

0.990

Small sample size

Design*

N = 10 and n = 7

N = 14 and n = 5

N = 10 and n = 5

ntot = 70

ntot = 70

ntot =50

Wald test (uncorrected)

62.2

99.8

100

61.8

100

100

55.2

98.8

100

Wald test (corrected)

44.2

98.4

100

50.4

100

100

35.8

95.8

100

Wilcoxon test

6.6

11.2

26.8

4.4

15.6

39.0

6.6

11.2

26.8

 

Design*

N = 20 and n = 7

N = 28 and n = 5

N = 20 and n = 5

ntot = 140

ntot = 140

ntot = 100

Middle sample size

Wald test (uncorrected)

83.4

100

100

86.8

100

100

77.8

100

100

Wald test (corrected)

69.0

100

100

78.0

100

100

58.8

100

100

Wilcoxon test

7.0

23.0

50.4

6.8

30.4

64.6

7.0

23.0

50.4

Large sample size

Design*

N = 30 and n = 7

N = 42 and n = 5

N = 30 and n = 5

ntot = 210

ntot = 210

ntot = 150

Wald test (uncorrected)

94.0

100

100

86.8

100

100

89.4

100

100

Wald test (corrected)

89.2

100

100

82.6

100

100

82.6

100

100

Wilcoxon test

7.4

31.0

67.0

9.2

43.8

85.0

7.4

31.0

67.0

  1. * N: number of patients per group of treatment; n: number of viral load measurements per patient; ntot: total numbers of observations per group of treatment.