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.



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OCR for page 107
Halcion: An Independent Assessment of Safety and Efficacy Data 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.

OCR for page 107
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 —

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Halcion: An Independent Assessment of Safety and Efficacy Data 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 —

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Halcion: An Independent Assessment of Safety and Efficacy Data 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 —

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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 —

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Halcion: An Independent Assessment of Safety and Efficacy Data 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 —

OCR for page 107
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 —

OCR for page 107
Halcion: An Independent Assessment of Safety and Efficacy Data 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 —

OCR for page 107
Halcion: An Independent Assessment of Safety and Efficacy Data 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

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Halcion: An Independent Assessment of Safety and Efficacy Data 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

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Halcion: An Independent Assessment of Safety and Efficacy Data 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

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Halcion: An Independent Assessment of Safety and Efficacy Data 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

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Halcion: An Independent Assessment of Safety and Efficacy Data 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

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Halcion: An Independent Assessment of Safety and Efficacy Data 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

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Halcion: An Independent Assessment of Safety and Efficacy Data 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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Halcion: An Independent Assessment of Safety and Efficacy Data 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