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22689

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

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Versions (1)
  1. 6/9/17 6/9/17 -
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Genentech, Inc.

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June 9, 2017

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Creative Commons BY-NC 3.0
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    POST-TREATMENT COUNT FINGERS DAY 0 CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    POST-TREATMENT COUNT FINGERS 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
    POST-TREATMENT COUNT FINGERS (DAY 0)
    Description

    POST-TREATMENT COUNT FINGERS (DAY 0)

    Assessment Not Done
    Description

    NOT_DONE [NOTDN]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C1272696
    Test Date:
    Description

    EXAM_DT [EXMDT]

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0011008
    Test Time:
    Description

    EXAM_TIME [EXMTM]

    Data type

    time

    Measurement units
    • 24 hr clock
    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0040223
    24 hr clock
    Count fingers?
    Description

    COUNT_FINGERS [CTFGR]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0229090
    UMLS CUI [1,3]
    C0449804
    If Yes, maximum distance:
    Description

    MAXIMUM_DISTANCE [MAXDST]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442747
    UMLS CUI [1,2]
    C0042793
    UMLS CUI [1,3]
    C0229090
    Hand movement?
    Description

    HAND_MOVEMENT [HDMVT]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0229090
    UMLS CUI [1,3]
    C0575809
    If Yes:
    Description

    HAND_MOVEMENT_DESC [HDMVTD]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0575809
    UMLS CUI [1,2]
    C0229090
    Light Perception?
    Description

    If hand movement is not measurable, please test:

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0042793
    UMLS CUI [1,2]
    C0229090
    UMLS CUI [1,3]
    C1154616
    If Yes:
    Description

    LIGHT_PERCEPTION_DES [LIPECD]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0442772
    UMLS CUI [1,2]
    C0229090
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    Similar models

    POST-TREATMENT COUNT FINGERS 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
    POST-TREATMENT COUNT FINGERS (DAY 0)
    NOT_DONE [NOTDN]
    Item
    Assessment Not Done
    boolean
    C0042793 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    EXAM_DT [EXMDT]
    Item
    Test Date:
    date
    C0042793 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    EXAM_TIME [EXMTM]
    Item
    Test Time:
    time
    C0042793 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Count fingers?
    integer
    C0042793 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    C0449804 (UMLS CUI [1,3])
    MAXIMUM_DISTANCE [MAXDST]
    Code List
    Count fingers?
    CL Item
    4 ft (1)
    CL Item
    2 ft (2)
    CL Item
    1 ft (3)
    Item
    If Yes, maximum distance:
    integer
    C0442747 (UMLS CUI [1,1])
    C0042793 (UMLS CUI [1,2])
    C0229090 (UMLS CUI [1,3])
    MAXIMUM_DISTANCE [MAXDST]
    Code List
    If Yes, maximum distance:
    CL Item
    4 ft (1)
    CL Item
    2 ft (2)
    CL Item
    1 ft (3)
    Item
    Hand movement?
    integer
    C0042793 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    C0575809 (UMLS CUI [1,3])
    COUNT_FINGERS [CTFGR]
    Code List
    Hand movement?
    CL Item
    Yes (1)
    CL Item
    No  (2)
    CL Item
    Not Done (3)
    Item
    If Yes:
    integer
    C0575809 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    HAND_MOVEMENT_DESC [HDMVTD]
    Code List
    If Yes:
    CL Item
    With Direction (1)
    CL Item
    Without Direction (2)
    Item
    Light Perception?
    integer
    C0042793 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    C1154616 (UMLS CUI [1,3])
    MAXIMUM_DISTANCE [MAXDST]
    Code List
    Light Perception?
    CL Item
    4 ft (1)
    CL Item
    2 ft (2)
    CL Item
    1 ft (3)
    Item
    If Yes:
    integer
    C0442772 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    LIGHT_PERCEPTION [LIPEC]
    Code List
    If Yes:
    CL Item
    With Projection (1)
    CL Item
    Without Projection (2)
    Back to the top of the page 

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