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22679

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Terms of use: You may not use this document or the information contained herein to a regulatory authority in connection with an application for a marketing authorization or any other regulatory submission without the express written consent of Roche Study #: FVF4170g Drug: Ranibizumab Study Title: A Phase III, Double-Masked, Multicenter, Randomized, Sham-Controlled Study Of The Efficacy And Safety Of Ranibizumab Injection In Subjects With Clinically Significant Macular Edema With Center Involvement Secondary To Diabetes Mellitus

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  1. 2017-06-09 2017-06-09 -
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Genentech, Inc.

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9 juni 2017

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Creative Commons BY-NC 3.0

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    CONTRAST SENSITIVITY (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

    CONTRAST SENSITIVITY (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

    Patient administration
    Beskrivning

    Patient administration

    Subject Number
    Beskrivning

    PT

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Beskrivning

    PTINIT

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1997894
    UMLS CUI [1,2]
    C2986440
    Report Date:
    Beskrivning

    VDT

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    CONTRAST SENSITIVITY (DAY 0)
    Beskrivning

    CONTRAST SENSITIVITY (DAY 0)

    Testing Distance: 1 meter
    Beskrivning

    DISTANCE_CHAR [DSTCHR]

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0429925
    Test Date:
    Beskrivning

    EXAM_DT [EXMDT]

    Datatyp

    date

    Måttenheter
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C0200150
    UMLS CUI [1,2]
    C0011008
    DD/MMM/YY
    Right Eye: Not Done
    Beskrivning

    NOT_DONE [NOTDN]

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0229089
    Total number correct =
    Beskrivning

    CORRECT_READING [COTRD]

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0846621
    UMLS CUI [1,2]
    C0229089
    Total CS Score =
    Beskrivning

    [(Total number correct - 3) X 0.05]

    Datatyp

    float

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0449820
    UMLS CUI [1,3]
    C0229089
    Left Eye: Not Done
    Beskrivning

    NOT_DONE [NOTDN]

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0229090
    Total number correct =
    Beskrivning

    CORRECT_READING [COTRD]

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0846621
    UMLS CUI [1,2]
    C0229090
    Total CS Score =
    Beskrivning

    [(Total number correct - 3) X 0.05]

    Datatyp

    float

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0449820
    UMLS CUI [1,3]
    C0229090

    Similar models

    CONTRAST SENSITIVITY (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Patient administration
    PT
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    PTINIT
    Item
    Subject Initials:
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    VDT
    Item
    Report Date:
    date
    C1302584 (UMLS CUI [1,1])
    Item Group
    CONTRAST SENSITIVITY (DAY 0)
    DISTANCE_CHAR [DSTCHR]
    Item
    Testing Distance: 1 meter
    text
    C0429925 (UMLS CUI [1])
    EXAM_DT [EXMDT]
    Item
    Test Date:
    date
    C0200150 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    NOT_DONE [NOTDN]
    Item
    Right Eye: Not Done
    boolean
    C0430888 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD]
    Item
    Total number correct =
    integer
    C0846621 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CONTRAST_SENS_SCORE [TCSS]
    Item
    Total CS Score =
    float
    C0430888 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    C0229089 (UMLS CUI [1,3])
    NOT_DONE [NOTDN]
    Item
    Left Eye: Not Done
    boolean
    C0430888 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    CORRECT_READING [COTRD]
    Item
    Total number correct =
    integer
    C0846621 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    CONTRAST_SENS_SCORE [TCSS]
    Item
    Total CS Score =
    float
    C0430888 (UMLS CUI [1,1])
    C0449820 (UMLS CUI [1,2])
    C0229090 (UMLS CUI [1,3])

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