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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-6 Non-Geriatric Studies: All Psychiatric

TABLE 5.9

NON-GERIATRIC STUDIES: 'ALL PSYCHIATRIC'

 

 

DOSE (MG)

 

% WITH 'ALL PSYCHIATRIC'

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

5.7

—

2.9

2041

1

.25-.5

—

145

5.9

—

3.9

6400

1

.25-.5

15-30

105

11.3

3.8

—

6041

1

.5

—

143

5.7

—

5.5

6042

1

.5

30

127

7.8

3.2

—

6004

1

.6

30

37

25.0

42.9

—

6043

2

.5

—

277

10.9

—

10.1

6016

2

.5

30

30

7.1

0.0

—

6044

2

.5

30

232

9.5

9.5

—

6402

4

.25

30

81

25.9

29.6

—

6045

4

.5

—

62

29.0

—

12.9

6046

4

.5

30

103

12.7

0.0

—

6047

6

.5

—

125

15.0

—

7.7

6048

6

.5

30

145

9.5

0.0

—

6023B

1.2

.5

30

18

8.3

16.7

—

6023

12

.6

30

51

21.2

22.2

—

6049

13

.5

30

139

23.0

15.1

—
Page
113