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22618

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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 #: FVF4168g 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. 08-06-17 08-06-17 -
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Genentech, Inc.

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8 juni 2017

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Creative Commons BY-NC 3.0

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    READING SPEED (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

    READING SPEED (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

    Patient administration
    Beschrijving

    Patient administration

    Subject Number
    Beschrijving

    PT

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Beschrijving

    PTINIT

    Datatype

    text

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

    VDT

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    READING SPEED (DAY 0)
    Beschrijving

    READING SPEED (DAY 0)

    Right Eye: Not Done
    Beschrijving

    NOT_DONE [NOTDN]

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0229089
    Card # used:
    Beschrijving

    CARD_NUMBER [CARDNO]

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C3275277
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C0229089
    1a. Time to Complete:
    Beschrijving

    READING_TIME [RDTM]

    Datatype

    time

    Maateenheden
    • m:ss
    Alias
    UMLS CUI [1,1]
    C1549507
    UMLS CUI [1,2]
    C0229089
    m:ss
    b. No. of words read CORRECTLY:
    Beschrijving

    CORRECT_READING [COTRD]

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0871221
    UMLS CUI [1,2]
    C0229089
    Left Eye: Not Done
    Beschrijving

    NOT_DONE [NOTDN]

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0229090
    Card # used:
    Beschrijving

    CARD_NUMBER [CARDNO]

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C3275277
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C0229090
    1a. Time to Complete:
    Beschrijving

    READING_TIME [RDTM]

    Datatype

    time

    Maateenheden
    • m:ss
    Alias
    UMLS CUI [1,1]
    C1549507
    UMLS CUI [1,2]
    C0229090
    m:ss
    b. No. of words read CORRECTLY:
    Beschrijving

    CORRECT_READING [COTRD]

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0871221
    UMLS CUI [1,2]
    C0229090

    Similar models

    READING SPEED (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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
    READING SPEED (DAY 0)
    NOT_DONE [NOTDN]
    Item
    Right Eye: Not Done
    boolean
    C0430888 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CARD_NUMBER [CARDNO]
    Item
    Card # used:
    integer
    C3275277 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0229089 (UMLS CUI [1,3])
    READING_TIME [RDTM]
    Item
    1a. Time to Complete:
    time
    C1549507 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    CORRECT_READING [COTRD]
    Item
    b. No. of words read CORRECTLY:
    integer
    C0871221 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    NOT_DONE [NOTDN]
    Item
    Left Eye: Not Done
    boolean
    C0430888 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    CARD_NUMBER [CARDNO]
    Item
    Card # used:
    integer
    C3275277 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0229090 (UMLS CUI [1,3])
    READING_TIME [RDTM]
    Item
    1a. Time to Complete:
    time
    C1549507 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    CORRECT_READING [COTRD]
    Item
    b. No. of words read CORRECTLY:
    integer
    C0871221 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])

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