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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-4 Non-Geriatric Studies: Irritability

TABLE 5.7

NON-GERIATRIC STUDIES: IRRITABILITY

 

 

DOSE (MG)

 

% WITH IRRITABILITY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

0.0

—

0.0

2401

1

.25-.5

—

145

1.5

—

3.9

6400

1

.25-.5

15-30

105

0.0

0.0

—

6041

1

.5

—

143

0.0

—

0.0

6042

1

.5

30

127

3.1

1.6

—

6004

1

.6

30

37

0.0

0.0

—

6043

2

.5

—

277

0.0

—

2.2

6016

2

.5

30

30

0.0

0.0

—

6044

2

.5

30

232

0.0

1.7

—

6402

4

.25

30

81

0.0

3.7

—

6045

4

.5

—

62

0.0

—

0.0

6046

4

.5

30

103

1.8

0.0

—

6047

6

.5

—

125

0.0

—

0.0

6048

6

.5

30

145

0.0

0.0

—

6023B

12

.5

30

18

0.0

0.0

—

6023

12

.6

30

51

0.0

0.0

—

6049

13

.5

30

139

1.4

0.0

—
Page
111