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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. 02/07/2017 02/07/2017 -
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Genentech, Inc.

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2 juillet 2017

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Creative Commons BY-NC 3.0
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    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30) CRFs Roche FVF4170G Macular Edema NCT00473382

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    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30) CRFs Roche FVF4170G Macular Edema NCT00473382

    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
    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)
    Description

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)

    Eye Treated:
    Description

    EYE (EYE)

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0015392 (Eye)
    SNOMED
    81745001
    LOINC
    LP7218-3
    Was treatment (Ranibizumab) administered?
    Description

    TX_RECEIVED (TXREC)

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216 (Pharmacotherapy)
    SNOMED
    416608005
    UMLS CUI [1,2]
    C1566537 (ranibizumab)
    SNOMED
    422456007
    Record Lot # Administered:
    Description

    If Yes,

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1115660 (Lot Number)
    Date Administered:
    Description

    TREATMENT_DATE (TXDT, TXDTF)

    Type de données

    date

    Unités de mesure
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C1566537 (ranibizumab)
    SNOMED
    422456007
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    DD/MMM/YY
    Time Administered:
    Description

    TIME_ADMINISTERED (TXTM)

    Type de données

    time

    Unités de mesure
    • 24 hr clock
    Alias
    UMLS CUI [1,1]
    C1566537 (ranibizumab)
    SNOMED
    422456007
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    24 hr clock
    Was lidocaine injection administered?
    Description

    LIDOCAINE (LDCON)

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023660 (lidocaine)
    SNOMED
    82573000
    Were preoperative antimicrobials given?
    Description

    ANTIBIOTICS_CURRENT (ABXCR)

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0003232 (Antibiotics)
    SNOMED
    255631004
    LOINC
    LP31426-7
    Retour au début de la page

    Similar models

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30) CRFs Roche FVF4170G Macular Edema NCT00473382

    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
    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)
    Item
    Eye Treated:
    integer
    C0015392 (UMLS CUI [1])
    EYE (EYE)
    Code List
    Eye Treated:
    CL Item
    Right Eye  (1)
    CL Item
    Left Eye  (2)
    CL Item
    Not Done (3)
    TX_RECEIVED (TXREC)
    Item
    Was treatment (Ranibizumab) administered?
    boolean
    C0013216 (UMLS CUI [1,1])
    C1566537 (UMLS CUI [1,2])
    LOT (LOT)
    Item
    Record Lot # Administered:
    text
    C1115660 (UMLS CUI [1])
    TREATMENT_DATE (TXDT, TXDTF)
    Item
    Date Administered:
    date
    C1566537 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    TIME_ADMINISTERED (TXTM)
    Item
    Time Administered:
    time
    C1566537 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    LIDOCAINE (LDCON)
    Item
    Was lidocaine injection administered?
    boolean
    C0023660 (UMLS CUI [1])
    ANTIBIOTICS_CURRENT (ABXCR)
    Item
    Were preoperative antimicrobials given?
    boolean
    C0003232 (UMLS CUI [1])
    Retour au début de la page 

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