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Halcion: An Independent Assessment of Safety and Efficacy Data (1997)
Institute of Medicine (IOM)

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. "Appendix A: FDA Safety Tables." Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press, 1997.

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Halcion: An Independent Assessment of Safety and Efficacy Data

TABLE A-1 Non-Geriatric Studies: Anxiety

TABLE 5.4

NON-GERIATRIC STUDIES: ANXIETY

 

 

DOSE (MG)

 

% WITH ANXIETY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

2.9

—

2.9

2401

1

.25-.5

—

145

4.4

—

1.3

6400

1

.25-.5

15-30

105

7.5

3.8

—

6041

1

.5

—

143

4.3

—

2.7

6042

1

.5

30

127

4.7

0.0

—

6004

1

.6

30

37

6.3

23.8

—

6043

2

.5

—

277

8.0

—

5.0

6016

2

.5

30

30

7.1

0.0

—

6044

2

.5

30

232

6.9

5.2

—

6402

4

.25

30

81

20.4

22.2

—

6045

4

.5

—

62

16.1

—

12.9

6046

4

.5

30

103

10.9

2.0

—

6047

6

.5

—

125

15.0

—

3.1

6048

6

.5

30

145

4.1

5.6

—

6023B

12

.5

30

18

8.3

0.0

—

6023

12

.6

30

51

9.1

0.0

—

6049

13

.5

30

139

13.5

8.2

—
Page
108