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Halcion An Independent Assessment of Safety and Efficacy Data (1997) / Chapter Skim
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Appendix A: FDA Safety Tables
Pages 107-122

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From page 107...
... 1992. Review of adverse event data in Upjohn-sponsored clinical studies of Halcion (triazolam)
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From page 109...
... I STUDY WEEKS TRZ | FLZ N 1 6401 1 1 1 .25 1 -- 1 70 1 2401 1 .25-.5 __ 145 1 6400 1 .25-.5 15-30 105 1 6041 1: .5 __ 143 5042 I 1 I .5 1 : D I 127 1, 1.0 1 U.U 1 6004 I 1 I .6 I : ~1 37 11 12.5 1 0.0 I 'ti~t ~1~ 03~0 ~ (.3:~.:1~32:~-'3<']
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From page 111...
... APPENDIX A TABLE A-4 111 Non-Geriatric Studies: irritability TABLE 5.7 NON-GERIATRIC STUDIES: IRRITABILITY ~ I DOSE (MG)
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From page 112...
... STUDY WEEKS TRZ | FLZ N 6401 1 1 1 .25 1 -- 1 70 I 2401 1 .25-.5 __ 145 I 6400 1 .25-.5 15-30 105 I 6041 1 .5 143 I 6042 1 .5 30 127 6004 I 1 T .6 I -} T 37 1. _ 1, 'art ~915~ ogre ~!
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From page 115...
... APPENDIX A TABLE A-8 115 Geriatric Studies: Anxiety TRZ TABLE 5.11 GERIATRIC STUDIES e ANXIETY · 1 DOSE (MG)
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From page 116...
... 116 TABLE A-9 H~4LCION: AN INDEPENDENT ASSESSMENT Geriatric Studies: Confusion TABLE 5.12 GERIATRIC STUDIES: CONFUSION I ~DOSE (MG)
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From page 118...
... 118 TABLE A-~l Geriatric Studies: irritability HALCION: AN INDEPENDENT ASSESSMENT _ TABLE 5.14 GERIATRIC STUDIES: IRRITABILITY .
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From page 120...
... I 'l : STUDY WEEKS TRZ FLZ N 6417 1 .125 __ 90 6417A 1 e 125-.25 __ 37 6061 1 .25 _ 59 6062 I 1 I .25 I 15 r 71 J1 U.U 1 U.U 1 4 2~; ~ ~ I| | ~ - Sat 1 ~ ~ ~.
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From page 121...
... APPENDIX A TABLE A-14 121 Non-Geriatric Studies -- | TABLE 2.2: NON-GERIATRIC STUDIES It I L DOSE (MG)
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Key Terms

  • event data
  • geriatric studies
  • clinical studies
  • adverse event
  • independent assessment

  • trz flz
  • study weeks
  • size study
  • drug administration


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