A
FDA Safety Tables
A-1 |
Non-Geriatric Studies: Anxiety, |
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A-2 |
Non-Geriatric Studies: Confusion, |
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A-3 |
Non-Geriatric Studies: Depression, |
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A-4 |
Non-Geriatric Studies: Irritability, |
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A-5 |
Non-Geriatric Studies: Memory Impairment, |
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A-6 |
Non-Geriatric Studies: All Psychiatric, |
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A-7 |
Non-Geriatric Studies: Sedative/Hypnotic, |
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A-8 |
Geriatric Studies: Anxiety, |
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A-9 |
Geriatric Studies: Confusion, |
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A-10 |
Geriatric Studies: Depression, |
|||
A-11 |
Geriatric Studies: Irritability, |
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A-12 |
Geriatric Studies: Memory Impairment, |
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A-13 |
Geriatric Studies: All Psychiatric, |
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A-14 |
Non-Geriatric Studies, |
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A-15 |
Geriatric Studies, |
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.
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 |
— |
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 |
— |
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 |
— |
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 |
— |
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 |
— |
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 |
— |
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 |
— |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
— |
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 |