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23312

Beschrijving

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

Trefwoorden

  1. 02-07-17 02-07-17 -
Houder van rechten

Genentech, Inc.

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2 juli 2017

DOI

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Creative Commons BY-NC 3.0

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    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34) CRFs Roche FVF4170G Macular Edema NCT00473382

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34) CRFs Roche FVF4170G Macular Edema NCT00473382

    Patient administration
    Beschrijving

    Patient administration

    Subject Number
    Beschrijving

    PT

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Beschrijving

    PTINIT

    Datatype

    text

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

    VDT

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34)
    Beschrijving

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34)

    Eye Treated:
    Beschrijving

    EYE (EYE)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0015392
    Was treatment (Ranibizumab) administered?
    Beschrijving

    TX_RECEIVED (TXREC)

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C1566537
    Record Lot # Administered:
    Beschrijving

    If Yes,

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1115660
    Date Administered:
    Beschrijving

    TREATMENT_DATE (TXDT, TXDTF)

    Datatype

    date

    Maateenheden
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C1566537
    UMLS CUI [1,2]
    C0011008
    DD/MMM/YY
    Time Administered:
    Beschrijving

    TIME_ADMINISTERED (TXTM)

    Datatype

    time

    Maateenheden
    • 24 hr clock
    Alias
    UMLS CUI [1,1]
    C1566537
    UMLS CUI [1,2]
    C0011008
    24 hr clock
    Was lidocaine injection administered?
    Beschrijving

    LIDOCAINE (LDCON)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023660
    Were preoperative antimicrobials given?
    Beschrijving

    ANTIBIOTICS_CURRENT (ABXCR)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0003232

    Similar models

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 34) CRFs Roche FVF4170G Macular Edema NCT00473382

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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 34)
    Item
    Eye Treated:
    integer
    C0015392 (UMLS CUI [1])
    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])

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