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Table 2 Sequence symmetry results of the 1000 simulations for different scenarios of medicine utilisation trends and different effect sizes, for a population size of 1 million and 5% incidence of use of each drug in the population

From: The performance of sequence symmetry analysis as a tool for post-market surveillance of newly marketed medicines: a simulation study

   

Crude sequence ratio

Adjusted sequence ratio

Medicine utilisation scenario

Pairs (N)

Null SR

Crude SR (95% CI)

Cover-age (%)

Power* (%)

Relative bias (%)

Adjusted SR (95% CI)

Cover-age (%)

Power* (%)

Relative bias (%)

Expected ASR = 1.0

 

No trend

225

1.00

1.01 (0.75-1.30)

94.3

1.8

2.42

1.01 (0.75-1.30)

94.5

1.6

2.42

Gradual

41

0.85

0.90 (0.31-1.60)

86.8

0.0

−4.33

1.06 (0.37-1.88)

94.5

0.1

12.18

Constant

100

0.84

0.85 (0.52-1.23)

81.1

0.1

−12.58

1.01 (0.61-1.46)

94.7

0.2

3.73

Rapid

113

0.88

0.90 (0.57-1.27)

87.3

0.0

−7.75

1.03 (0.65-1.45)

95.2

1.3

4.97

Expected ASR = 1.2

 

No trend

247

1.00

1.21 (0.91-1.55)

95.9

20.7

2.84

1.21 (0.91-1.55)

95.7

20.8

2.84

Gradual

44

0.85

1.08 (0.40-1.91)

90.6

0.0

−3.73

1.27 (0.47-2.24)

96.9

0.5

12.90

Constant

110

0.84

1.04 (0.65-1.47)

81.5

1.3

−11.45

1.23 (0.77-1.75)

94.9

7.9

5.05

Rapid

124

0.88

1.07 (0.70-1.49)

87.4

1.4

−8.70

1.22 (0.79-1.70)

95.8

7.8

3.90

Expected ASR = 1.5

 

No trend

280

1.00

1.51 (1.15-1.92)

95.6

85.5

2.54

1.51 (1.15-1.92)

95.4

85.8

2.52

Gradual

50

0.85

1.36 (0.56-2.33)

86.7

0.6

−3.58

1.59 (0.66-2.74)

95.6

5.6

13.10

Constant

124

0.84

1.29 (0.84-1.82)

81.1

13.3

−11.39

1.54 (1.00-2.16)

96.2

45.4

5.12

Rapid

139

0.88

1.35 (0.90-1.87)

86.9

24.6

−7.53

1.54 (1.03-2.13)

95.9

52.3

5.20

Expected ASR = 2.0

 

No trend

337

1.00

2.03 (1.57-2.55)

96.1

100.0

2.91

2.03 (1.57-2.55)

96.2

100.0

2.89

Gradual

60

0.85

1.79 (0.81-3.01)

87.7

17.7

−4.59

2.10 (0.95-3.53)

95.6

40.6

11.87

Constant

146

0.84

1.72 (1.15-2.39)

80.6

76.1

−11.44

2.04 (1.37-2.84)

96.1

97.0

5.08

Rapid

166

0.88

1.79 (1.23-2.45)

87.5

90.7

−7.96

2.04 (1.40-2.79)

97.0

98.7

4.71

Expected ASR = 3.0

 

No trend

450

1.00

3.03 (2.40-3.77)

96.4

100.0

2.84

3.03 (2.40-3.77)

96.2

100.0

2.85

Gradual

78

0.85

2.67 (1.30-4.47)

87.8

90.8

−3.94

3.14 (1.52-5.24)

96.3

97.9

12.66

Constant

192

0.84

2.59 (1.79-3.55)

80.5

100.0

−11.16

3.07 (2.12-4.21)

97.5

100.0

5.39

Rapid

219

0.88

2.67 (1.90-3.59)

83.4

100.0

−8.50

3.03 (2.16-4.09)

96.0

100.0

4.12

Expected ASR = 0.6

 

No trend

300

1.00

0.61 (0.46-0.76)

95.6

99.0

1.66

0.61 (0.46-0.76)

95.6

99.0

1.68

Gradual

56

0.85

0.53 (0.23-0.85)

86.8

77.9

−9.71

0.62 (0.27-1.00)

95.2

57.0

5.92

Constant

136

0.84

0.51 (0.33-0.70)

79.2

98.2

−14.48

0.61 (0.39-0.83)

94.9

90.0

1.46

Rapid

154

0.88

0.53 (0.35-0.71)

83.7

98.6

−11.09

0.60 (0.40-0.81)

94.5

91.1

1.14

Expected ASR = 0.8

 

No trend

254

1.00

0.81 (0.61-1.03)

95.4

44.5

2.09

0.81 (0.61-1.03)

95.7

44.5

2.10

Gradual

46

0.85

0.72 (0.28-1.21)

89.1

32.7

−6.68

0.84 (0.33-1.42)

95.9

16.6

9.43

Constant

114

0.84

0.69 (0.43-0.97)

79.5

60.4

−13.09

0.82 (0.50-1.15)

95.0

29.1

3.14

Rapid

129

0.88

0.71 (0.46-0.98)

83.2

55.8

−9.95

0.81 (0.52-1.12)

94.1

30.9

2.47

  1. *Note: When the expected Sequence ratio =1, Power is the type I error.