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PAPERBACK price:$39.00 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources PDF SUMMARY Display this book on your site! Related Titles CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals: Workshop Summary Other Related Titles Halcion: An Independent Assessment of Safety and Efficacy Data (1997) Institute of Medicine (IOM) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "Appendix A: FDA Safety Tables." Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press, 1997. Please select a format: Page 107   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. 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 107 Front Matter (R1-R18) Executive Summary (1-9) Introduction (10-19) Assessment of Efficacy Data (20-48) Assessment of Safety Data (49-93) Additional Comments on Broader Implications (94-96) References (97-106) Appendix A: FDA Safety Tables (107-122) Appendix B: Summary Tables of Literature Reviewed for Safety of Halcion (123-142) Appendix C: Glossary (143-144) Appendix D: Acronyms (145-145) Appendix E: Resources Reviewed by the Committee (146-149) Appendix F: Upjohn Consent to Disclosure (150-152) Appendix G: Committee and Staff Biographies (153-158)

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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.

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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 —

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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 —

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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 —

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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

Representative terms from entire chapter:

anxiety geriatric