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22681

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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. 6/9/17 6/9/17 -
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Genentech, Inc.

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June 9, 2017

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    INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

    English

    INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

    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
    INTRAOCULAR PRESSURE (DAY 0)
    Description

    INTRAOCULAR PRESSURE (DAY 0)

    Pre-dose Right Eye
    Description

    INTRAOCULAR_PRESSURE [ IOP]

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0578862
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0229089
    mmHg
    Pre-dose Right Eye Not Done
    Description

    INTRAOCULAR_PRESSURE [ IOP]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0578862
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0229089
    Pre-dose Left Eye
    Description

    INTRAOCULAR_PRESSURE [ IOP]

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0578862
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0229090
    mmHg
    Pre-dose Left Eye Not Done
    Description

    INTRAOCULAR_PRESSURE [ IOP]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0578862
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0229090
    Predose Date
    Description

    EXAM_DT [EXMDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0011008
    DD/MMM/YY
    Predose Actual Time
    Description

    EXAM_TIME [EXMTM]

    Data type

    time

    Measurement units
    • 24 hr clock
    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0040223
    24 hr clock
    Predose Method
    Description

    Method must be consistent for a subject throughout the study.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0871511
    60 min post-dose Study Eye
    Description

    QV: STUDY EYE

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0578862
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0681850
    mmHg
    60 min post-dose Study Eye Not Done
    Description

    QV: STUDY EYE

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0578862
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C0681850
    60 min post-dose Date
    Description

    EXAM_DT [EXMDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0439571
    UMLS CUI [1,3]
    C0011008
    DD/MMM/YY
    60 min post-dose Actual Time
    Description

    EXAM_TIME [EXMTM]

    Data type

    time

    Measurement units
    • 24 hr clock
    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0439571
    UMLS CUI [1,3]
    C0040223
    24 hr clock
    60 min post-dose Method
    Description

    Method must be consistent for a subject throughout the study.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0430888
    UMLS CUI [1,2]
    C0439571
    UMLS CUI [1,3]
    C0871511
    Back to the top of the page

    Similar models

    INTRAOCULAR PRESSURE (DAY 0) CRFs Roche FVF4170G Macular Edema NCT00473382

    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
    INTRAOCULAR PRESSURE (DAY 0)
    INTRAOCULAR_PRESSURE [ IOP]
    Item
    Pre-dose Right Eye
    integer
    C0578862 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0229089 (UMLS CUI [1,3])
    INTRAOCULAR_PRESSURE [ IOP]
    Item
    Pre-dose Right Eye Not Done
    boolean
    C0578862 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0229089 (UMLS CUI [1,3])
    INTRAOCULAR_PRESSURE [ IOP]
    Item
    Pre-dose Left Eye
    integer
    C0578862 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0229090 (UMLS CUI [1,3])
    INTRAOCULAR_PRESSURE [ IOP]
    Item
    Pre-dose Left Eye Not Done
    boolean
    C0578862 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0229090 (UMLS CUI [1,3])
    EXAM_DT [EXMDT]
    Item
    Predose Date
    date
    C0430888 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    EXAM_TIME [EXMTM]
    Item
    Predose Actual Time
    time
    C0430888 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Predose Method
    integer
    C0430888 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0871511 (UMLS CUI [1,3])
    PROCEDURE_TYPE [PRCTYP]
    Code List
    Predose Method
    CL Item
    Applanation tonometry (1)
    CL Item
    Non-contact tonometry (2)
    CL Item
    Tonopen (3)
    CL Item
    Pneumotonometry (4)
    QV: STUDY EYE
    Item
    60 min post-dose Study Eye
    integer
    C0578862 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0681850 (UMLS CUI [1,3])
    QV: STUDY EYE
    Item
    60 min post-dose Study Eye Not Done
    boolean
    C0578862 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C0681850 (UMLS CUI [1,3])
    EXAM_DT [EXMDT]
    Item
    60 min post-dose Date
    date
    C0430888 (UMLS CUI [1,1])
    C0439571 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    EXAM_TIME [EXMTM]
    Item
    60 min post-dose Actual Time
    time
    C0430888 (UMLS CUI [1,1])
    C0439571 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    60 min post-dose Method
    integer
    C0430888 (UMLS CUI [1,1])
    C0439571 (UMLS CUI [1,2])
    C0871511 (UMLS CUI [1,3])
    PROCEDURE_TYPE [PRCTYP]
    Code List
    60 min post-dose Method
    CL Item
    Applanation tonometry (1)
    CL Item
    Non-contact tonometry (2)
    CL Item
    Tonopen (3)
    CL Item
    Pneumotonometry (4)
    Back to the top of the page 

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