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

Chapter: Appendix A: FDA Safety Tables

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Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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A
FDA Safety Tables

A-1

 

Non-Geriatric Studies: Anxiety,

 

108

A-2

 

Non-Geriatric Studies: Confusion,

 

109

A-3

 

Non-Geriatric Studies: Depression,

 

110

A-4

 

Non-Geriatric Studies: Irritability,

 

111

A-5

 

Non-Geriatric Studies: Memory Impairment,

 

112

A-6

 

Non-Geriatric Studies: All Psychiatric,

 

113

A-7

 

Non-Geriatric Studies: Sedative/Hypnotic,

 

114

A-8

 

Geriatric Studies: Anxiety,

 

115

A-9

 

Geriatric Studies: Confusion,

 

116

A-10

 

Geriatric Studies: Depression,

 

117

A-11

 

Geriatric Studies: Irritability,

 

118

A-12

 

Geriatric Studies: Memory Impairment,

 

119

A-13

 

Geriatric Studies: All Psychiatric,

 

120

A-14

 

Non-Geriatric Studies,

 

121

A-15

 

Geriatric Studies,

 

122

Source of all tables:. Laughren, T.P. and H. Lee. 1992. Review of adverse event data in Upjohn-sponsored clinical studies of Halcion (triazolam), NDA 17-892. Report made to U.S. Food and Drug Administration.

Page 108 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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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 109 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-2 Non-Geriatric Studies: Confusion

TABLE 5.5

NON-GERIATRIC STUDIES: CONFUSION

 

 

DOSE (MG)

 

% WITH CONFUSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

0.0

-

0.0

2401

1

.25-.5

—

145

0.0

—

0.0

6400

1

.25-.5

15-30

105

0.0

0.0

—

6041

1

.5

—

143

0.0

—

0.0

6042

1

.5

30

127

1.6

0.0

—

6004

1

.6

30

37

12.5

0.0

—

6043

2

.5

—

277

0.0

—

0.7

6016

2

.5

30

30

0.0

0.0

—

6044

2

.5

30

232

0.0

0.0

—

6402

4

.25

30

81

0.0

0.0

—

6045

4

.5

—

6'2

6.5

—

0.0

6046

4

.5

30

10.3

0.0

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

3.0

5.6

—

6049

13

.5

30

139

2.7

0.0

—

Page 110 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-3 Non-Geriatric Studies: Depression

TABLE 5.6

NON-GERIATRIC STUDIES: DEPRESSION

 

 

DOSE (MG)

 

% WITH DEPRESSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

0.0

—

0.0

2401

1

.25-.5

—

145

0.0

—

0.0

66400

1

.25-.5

15-30

105

0.0

0.0

—

6041

1

.5

—

143

1.4

—

2.7

6042

1

.5

3.0

127

0.0

0.0

—

6004

1

.6

30

37

0.0

0.0

—

6043

2

.5

—

277

2.2

—

0.7

6016

2

.5

30

30

0.0

0.0

—

6044

2

.5

30

232

2.6

3.4

—

6402

4

.25

30

81

3.7

0.0

—

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

4.1

4.2

—

60238

12

.5

30

18

0.0

0.0

—

6023

12

6

30

51

3.0

0.0

—

6049

13

.5

30

139

6.8

6.8

—

Page 111 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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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 112 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-5 Non-Geriatric Studies: Memory Impairment

TABLE 5.8

NON-GERIATRIC STUDIES: MEMORY IMPAIRMENT

 

 

DOSE (MG)

 

% WITH MEMORY IMPAIRMENT

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

0.0

—

0.0

2401

1

.25-.5

—

145

0.0

—

0.0

6400

1

.25-.5

15-30

105

0.0

0.0

—

6041

1

.5

—

143

0.0

—

0.0

6042

1

.5

30

127

1.6

1.6

—

6004

1

.6

30

37

6.3

0.0

—

6043

2

.5

—

277

0.0

—

0.0

6016

2

.5

30

30

0.0

0.0

—

6044

2

.5

30

232

0.0

0.0

—

6402

4

.25

30

81

0.0

0.0

—

6045

4

.5

—

62

0.0

—

0.0

6046

4

.5

30

103

0.0

0.0

—

6047

6

.5

—

125

1.7

—

0.0

6048

6

.5

30

145

1.4

0.0

—

6023B

12

.5

30

18

8.3

0.0

—

6023

12

.6

30

51

15.2

0.0

—

6049

13

.5

30

139

6.8

0.0

—

Page 113 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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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 114 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-7 Non-Geriatric Studies: Sedative/Hypnotic

TABLE 5.10

NON-GERIATRIC STUDIES: 'SEDATIVE/HYPNOTIC'

 

 

DOSE (MG)

 

% WITH 'SEDATIVE HYPNOTIC'

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6401

1

.25

—

70

17.1

—

11.4

2401

1

.25-.5

—

145

75.0

—

84.4

6400

1

.25-.5

15-30

105

20.8

21.2

—

6041

1

.5

—

143

24.3

—

12.3

6042

1

..5

30

127

21.9

17.5

—

6004

1

.6

30

37

50.0

47.6

—

6043

2

.5

—

277

35.5

—

19.4

6016

2

.5

30

30

14.3

25.0

—

6044

2

.5

30

232

37.1

44.0

—

6402

4

.25

30

81

33.3

59.3

—

6045

4

.5

—

62

54.8

—

12.9

6046

4

.5

30

103

43.6

36.0

—

6047

6

.5

—

125

36.7

—

13.8

6048

6

.5

30

145

25.7

31.0

—

6023B

12

.5

30

18

41.7

50.0

—

6023

12

.6

30

51

33.3

77.8

—

6049

13

.5

30

139

37.8

42.5

—

Page 115 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-8 Geriatric Studies: Anxiety

TABLE 5.11

GERIATRIC STUDIES: ANXIETY

 

 

DOSE (MG)

 

% WITH ANXIETY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

—

90

2.2

—

9.1

6417A

1

.125-.25

—

37

0.0

—

15.8

6061

1

.25

—

59

0.0

—

0.0

6062

1

.25

15

71

0.0

0.0

—

6063

2

.25

—

38

5.6

—

10.0

6064

2

.25

15

43

10.0

0.0

—

6065

4

.25

15

41

14.3

0.0

0.0

2601

4

.25-.5

15-30

121

30.0

17.5

14.6

Page 116 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-9 Geriatric Studies: Confusion

TABLE 5.12

GERIATRIC STUDIES: CONFUSION

 

 

DOSE (MG)

 

% WITH CONFUSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

—

90

0.0

—

2.3

6417A

1

.125-.25

—

37

0.0

—

0.0

6061

1

.25

—

59

0.0

—

0.0

6062

1

.25

15

71

0.0

0.0

—

6063

2

.25

—

38

5.6

—

0.0

6064

2

.25

15

43

0.0

4.3

—

6065

4

.25

15

41

0.0

0.0

0.0

2601

4

.25-.5

15-30

121

5.0

2.5

2.4

Page 117 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-10 Geriatric Studies: Depression

TABLE 5.13

GERIATRIC STUDIES: DEPRESSION

 

 

DOSE (MG)

 

% WITH DEPRESSION

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

—

90

0.0

—

0.0

6417A

1

.125-.25

—

37

0.0

—

0.0

6061

1

.25

—

59

0.0

—

0.0

6062

1

.25

15

71

0.0

0.0

—

6063

2

.25

—

38

5.6

—

0.0

6064

2

.25

15

43

10.0

0.0

—

6065

4

.25

15

41

0.0

0.0

0.0

2601

4

.25-.5

15-30

121

7.5

5.0

7.3

Page 118 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-11 Geriatric Studies: Irritability

TABLE 5.14

GERIATRIC STUDIES: IRRITABILITY

 

 

DOSE (MG)

 

% WITH IRRITABILITY

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

—

90

0.0

—

0.0

6417A

1

.125-.25

—

37

0.0

—

0.0

6061

1

.25

—

59

0.0

—

0.0

6062

1

.25

15

71

0.0

0.0

—

6063

2

.25

—

38

0.0

—

0.0

6064

2

.25

15

43

0.0

0.0

—

6065

4

.25

1.5

41

7.1

0.0

0.0

2601

4

.25-.5

15-30

121

5.0

0.0

2.4

Page 119 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-12 Geriatric Studies: Memory Impairment

TABLE 5.15

GERIATRIC STUDIES: MEMORY IMPAIRMENT

 

 

DOSE (MG)

 

% WITH MEMORY IMPAIRMENT

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

—

90

0.0

—

0.0

6417A

1

.125-.25

—

37

0.0

—

0.0

6061

1

.25

—

59

0.0

—

0.0

6062

1

.25

15

71

0.0

0.0

—

6063

2

.25

—

38

0.0

—

0.0

6064

2

.25

15

43

0.0

0.0

—

6065

4

.25

15

41

0.0

0.0

0.0

2601

4

.25-.5

15-30

121

2.5

0.0

0.0

Page 120 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-13 Geriatric Studies: All Psychiatric

TABLE 5.16

GERIATRIC STUDIES: 'ALL PSYCHIATRIC'

 

 

DOSE (MG)

 

% WITH 'ALL PSYCHIATRIC'

STUDY

WEEKS

TRZ

FLZ

N

TRZ

FLZ

PBO

6417

1

.125

—

90

2.2

—

13.6

6417A

1

.1250.25

—

37

0.0

—

15.8

6061

1

.25

—

59

0.0

—

0.0

6062

1

.25

15

71

0.0

0.0

—

6063

2

.25

—

38

11.1

—

10.1

6064

2

25

15

43

15.0

4.3

—

6065

4

.25

15

41

14.3

0.0

0.0

2601

4

.25-.5

15-30

121

47.5

32.5

26.8

Page 121 Cite Bookmark
Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-14 Non-Geriatric Studies

TABLE 2.2:

NON-GERIATRIC STUDIES

 

 

DOSE (MG)

GROUPS/SAMPLE SIZE

STUDY

WEEKS

TRZ

FLZ

TRZ

FLZ

PBO

6401

1

.25

—

35

—

35

2401

1

.25-.5

—

66

—

77

6400

1

.25-.5

15-30

53

52

—

6041

1

.5

—

70

—

72

6042

1

.5

30

62

59

—

6004

1

.6

30

16

21

—

6043

2

.5

—

138

—

135

6016

2

.5

30

14

16

—

6044

2

.5

30

112

110

—

6402

4

.25

30

54

27

—

6045

4

.5

—

31

—

31

6046

4

.5

30

55

50

—

6047

6

.5

—

59

—

64

6048

6

.5

30

72

71

—

6023B

12

.5

30

9

6

—

6023

12

.6

30

33

18

—

6049

13

.5

30

74

73

—

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Suggested Citation: "Appendix A: FDA Safety Tables." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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TABLE A-15 Geriatric Studies

TABLE 2.3:

GERIATRIC STUDIES

 

 

DOSE (MG)

GROUPS/SAMPLE SIZE

STUDY

WEEKS

TRZ

FLZ

TRZ

FLZ

PBO

6417

1

.125

—

46

—

44

6417A

1

.125-.25

—

18

—

19

6061

1

.25

—

31

—

28

6062

1

.25

15

36

35

—

6063

2

.25

—

18

—

20

6064

2

.25

15

20

23

—

6065

4

.25

15

14

13

14

2601

4

.25-.5

15-30

32

33

27

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Next Chapter: Appendix B: Summary Tables of Literature Reviewed for Safety of Halcion
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