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Table 5 Estimated incidence rates and relative risks for mild or greater AR. The number of expected cases were based on estimated incidence rates utilizing the pooled control (unexposed) groups of these studies. Relative risks and z statistics were calculated within each study.

From: Risk of valvular heart disease associated with use of fenfluramine

Author, year

Duration (months)

"Incident" cases

Expected cases

p-value by Poisson

Relative Risk (RR)

Lower 95% CI of RR

Upper 95% CI of RR

z

p-value

Khan, 1998

26.5

38.9

1.939

<0.00001

59.5

31.6

112.1

12.7

<0.00001

 

4.9

3.5

0.086

<0.00001

69.1

31.1

153.4

10.4

<0.00001

 

9.0

5.6

0.125

<0.00001

108.0

57.1

204.4

14.4

<0.00001

Weissman, 1998

2.4

11.6

0.696

<0.00001

15.3

8.4

27.9

8.9

<0.00001

Shively, 1999

6.9

9.3

0.685

<0.00001

38.4

18.9

78.0

10.1

<0.00001

Hensrud, 1999

9.6

3.3

0.075

<0.00001

7.8

1.2

51.8

2.1

0.016

Ryan, 1999

16.7

13

0.600

<0.00001

-

-

-

-

-

Gardin, 2000

2.0

0.03

0.042

0.96

0.7

0.0

61295

-0.1

0.52

 

4.5

10.3

0.226

<0.00001

47.8

31.3

73.0

17.9

<0.00001

 

9.0

8.2

0.459

<0.00001

18.8

10.6

33.3

10.0

<0.00001

 

15.0

10.5

0.563

<0.00001

19.5

11.6

32.9

11.2

<0.00001

 

22.0

14.5

0.816

<0.00001

18.7

11.6

30.0

12.1

<0.00001

 

2.0

0

0.080

0.92

0.0

0.0

-

-0.3

0.60

 

4.5

7.5

0.359

<0.00001

26.1

15.0

45.2

11.6

<0.00001

 

9.0

16.2

0.652

<0.00001

31.0

20.6

46.7

16.5

<0.00001

 

15.0

2.8

0.190

0.0010

18.5

7.6

45.1

6.4

<0.00001

Jollis, 2000

2.0

0.10

0.022

0.022

5.1

0.0

1233

0.6

0.28

 

4.5

2.8

0.618

0.026

4.8

1.6

14.9

2.8

0.0029

 

9.0

14.1

1.638

<0.00001

9.3

5.4

15.9

8.1

<0.00001

 

18.0

31.7

2.486

<0.00001

13.8

9.2

20.6

12.7

<0.00001

 

30.0

11.9

1.131

<0.00001

11.4

6.6

19.7

8.7

<0.00001

Davidoff, 2001

2.5

5.0

0.300

<0.00001

20.8

9.9

43.4

8.1

<0.00001

Summary, 2002

8.78

220.8

14.01

<0.00001

19.6

16.3

23.5

31.7

<0.00001