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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 -
Détendeur de droits

Genentech, Inc.

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8 giugno 2017

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Creative Commons BY-NC 3.0
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    INTRAOCULAR PRESSURE (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

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    INTRAOCULAR PRESSURE (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 Formulaires  
    Patient administration
    Description

    Patient administration

    Subject Number
    Description

    PT

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Subject Initials:
    Description

    PTINIT

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1997894 (Clinical trial participant (person))
    SNOMED
    428024001
    UMLS CUI [1,2]
    C2986440 (Person Initials)
    Report Date:
    Description

    VDT

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1302584 (Date of report)
    SNOMED
    399651003
    INTRAOCULAR PRESSURE (SCREENING)
    Description

    INTRAOCULAR PRESSURE (SCREENING)

    Date
    Description

    EXAM_DT [EXMDT]

    Type de données

    date

    Unités de mesure
    • DD/MMM/YY
    Alias
    UMLS CUI [1]
    C2826643 (Physical Examination Date)
    DD/MMM/YY
    Right Eye
    Description

    QV: RIGHT EYE

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0578862 (Intraocular pressure finding)
    SNOMED
    302157000
    UMLS CUI [1,2]
    C0229089 (Right eye)
    SNOMED
    18944008
    LOINC
    LA16257-0
    mmHg
    Not Done
    Description

    NOT_DONE [NOTDN]

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0430888 (Intraocular pressure test)
    SNOMED
    252832004
    LOINC
    LP29679-5
    UMLS CUI [1,2]
    C0229089 (Right eye)
    SNOMED
    18944008
    LOINC
    LA16257-0
    Left Eye
    Description

    QV: LEFT EYE

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0578862 (Intraocular pressure finding)
    SNOMED
    302157000
    UMLS CUI [1,2]
    C0229090 (Left eye structure)
    SNOMED
    8966001
    LOINC
    LA14704-3
    mmHg
    Not Done
    Description

    NOT_DONE [NOTDN]

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0430888 (Intraocular pressure test)
    SNOMED
    252832004
    LOINC
    LP29679-5
    UMLS CUI [1,2]
    C0229090 (Left eye structure)
    SNOMED
    8966001
    LOINC
    LA14704-3
    *Method
    Description

    *Method must be consistent for a subject throughout the study.

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0430888 (Intraocular pressure test)
    SNOMED
    252832004
    LOINC
    LP29679-5
    Retour au début de la page

    Similar models

    INTRAOCULAR PRESSURE (SCREENING) CRFs Roche FVF4168G Macular Edema NCT00473330

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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 (SCREENING)
    EXAM_DT [EXMDT]
    Item
    Date
    date
    C2826643 (UMLS CUI [1])
    QV: RIGHT EYE
    Item
    Right Eye
    integer
    C0578862 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    NOT_DONE [NOTDN]
    Item
    Not Done
    boolean
    C0430888 (UMLS CUI [1,1])
    C0229089 (UMLS CUI [1,2])
    QV: LEFT EYE
    Item
    Left Eye
    integer
    C0578862 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    NOT_DONE [NOTDN]
    Item
    Not Done
    boolean
    C0430888 (UMLS CUI [1,1])
    C0229090 (UMLS CUI [1,2])
    Item
    *Method
    integer
    C0430888 (UMLS CUI [1])
    PROCEDURE_TYPE [PRCTYP]
    Code List
    *Method
    CL Item
    Applanation tonometry (1)
    CL Item
    Non-contact tonometry (2)
    CL Item
    Tonopen (3)
    CL Item
    Pneumotonometry (4)
    Retour au début de la page 

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