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Table 1 Sequence symmetry results of the 1000 simulations for different scenarios of medicine utilisation trends and effect sizes, for a population size of 1 million and 20% population prevalence of use of each drug

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

3597

1.00

1.00 (0.94-1.07)

95.5

2.2

0.38

1.00 (0.94-1.07)

95.6

2.1

0.38

Gradual

656

0.85

0.86 (0.73-1.00)

47.6

0.0

−13.85

1.00 (0.85-1.17)

94.4

2.1

1.02

Constant

1604

0.84

0.84 (0.76-0.93)

7.3

0.0

−15.34

1.00 (0.90-1.11)

95.2

1.9

0.46

Rapid

1811

0.88

0.88 (0.80-0.97)

22.4

0.0

−11.71

1.00 (0.91-1.10)

96.1

2.2

0.46

Expected ASR = 1.2

 

No trend

3956

1.00

1.20 (1.13-1.28)

94.2

100.0

0.35

1.20 (1.13-1.28)

94.7

100.0

0.36

Gradual

717

0.85

1.03 (0.88-1.19)

42.8

5.1.0

−13.51

1.21 (1.03-1.40)

94.6

66.4

1.43

Constant

1754

0.84

1.01 (0.92-1.11)

4.8

2.9

−15.52

1.20 (1.09-1.32)

94.8

96.0

0.23

Rapid

1983

0.88

1.05 (0.96-1.15)

18.9

19.8

−11.85

1.20 (1.09-1.31)

94.2

96.8

0.31

Expected ASR = 1.5

 

No trend

4498

1.00

1.50 (1.41-1.59)

95.2

100.0

0.19

1.50 (1.41-1.59)

95.6

100.0

0.18

Gradual

806

0.85

1.29 (1.11-1.48)

41.0

92.2

−13.82

1.51 (1.30-1.73)

95.6

100.0

1.07

Constant

1973

0.84

1.27 (1.15-1.39)

3.9

100.0

−15.29

1.50 (1.37-1.65)

96.0

100.0

0.50

Rapid

2238

0.88

1.32 (1.21-1.44)

16.6

100.0

−11.67

1.50 (1.38-1.64)

95.6

100.0

0.50

Expected ASR = 2.0

 

No trend

5395

1.00

2.00 (1.90-2.12)

94.2

100.0

0.42

2.00 (1.90-2.12)

94.7

100.0

0.42

Gradual

957

0.85

1.72 (1.49-1.96)

36.7

100.0

−13.92

2.01 (1.74-2.29)

95.2

100.0

0.95

Constant

2338

0.84

1.69 (1.55-1.84)

2.4

100.0

−15.29

2.00 (1.83-2.19)

95.7

100.0

0.50

Rapid

2660

0.88

1.76 (1.62-1.91)

11.2

100.0

−11.69

2.00 (1.85-2.17)

96.1

100.0

0.48

Expected ASR = 3.0

 

No trend

7197

1.00

3.00 (2.85-3.17)

95.1

100.0

0.26

3.00 (2.85-3.17)

95.1

100.0

0.27

Gradual

1260

0.85

2.57 (2.26-2.90)

29.2

100.0

−13.92

3.01 (2.65-3.41)

95.8

100.0

0.98

Constant

3074

0.84

2.54 (2.35-2.75)

0.9

100.0

−15.00

3.01 (2.79-3.26)

95.4

100.0

0.82

Rapid

3510

0.88

2.63 (2.45-2.84)

8.6

100.0

−11.72

3.00 (2.79-3.24)

93.5

100.0

0.44

Expected ASR = 0.6

 

No trend

4799

1.00

0.60 (0.56-0.64)

94.0

100.0

−0.03

0.60 (0.56-0.64)

94.0

100.0

−0.03

Gradual

893

0.85

0.51 (0.44-0.58)

32.6

100.0

−14.61

0.60 (0.52-0.68)

95.7

100.0

0.13

Constant

2187

0.84

0.51 (0.46-0.55)

23

100.0

−15.54

0.60 (0.55-0.66)

96.3

100.0

0.21

Rapid

2456

0.88

0.53 (0.48-0.57)

12.1

100.0

−11.90

0.60 (0.55-0.65)

96.3

100.0

0.24

Expected ASR =0.80

 

No trend

4048

1.00

0.80 (0.75-0.85)

95.7

100.0

0.11

0.80 (0.75-0.85)

95.7

100.0

0.10

Gradual

745

0.85

0.68 (0.58-0.79)

39.4

100.0

−14.30

0.80 (0.68-0.92)

95.5

86.3

0.51

Constant

1823

0.84

0.68 (0.61-0.74)

4.8

100.0

−15.49

0.80 (0.73-0.88)

95.0

99.9

0.27

Rapid

2054

0.88

0.70 (0.64-0.77)

15.8

100.0

−12.17

0.80 (0.73-0.87)

95.6

99.9

−0.07

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