ID

22617

Description

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

Keywords

Versions (1)
  1. 6/8/17 6/8/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 8, 2017

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License

Creative Commons BY-NC 3.0
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    CONTRAST SENSITIVITY (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    CONTRAST SENSITIVITY (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms  
    Patient administration
    Description

    Patient administration

    Subject Number
    Description

    PT

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Description

    PTINIT

    Data type

    text

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

    VDT

    Data type

    date

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

    CONTRAST SENSITIVITY (DAY 0)

    Testing Distance: 1 meter
    Description

    DISTANCE_CHAR [DSTCHR]

    Data type

    text

    Alias
    UMLS CUI [1]
    C0429925
    Test Date:
    Description

    EXAM_DT [EXMDT]

    Data type

    date

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

    NOT_DONE [NOTDN]

    Data type

    boolean

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

    CORRECT_READING [COTRD]

    Data type

    integer

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

    [(Total number correct - 3) X 0.05]

    Data type

    float

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

    NOT_DONE [NOTDN]

    Data type

    boolean

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

    CORRECT_READING [COTRD]

    Data type

    integer

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

    [(Total number correct - 3) X 0.05]

    Data type

    float

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

    CONTRAST SENSITIVITY (DAY 0) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Back to the top of the page 

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