ID

23304

Beschreibung

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. 02.07.17 02.07.17 -
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Genentech, Inc.

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2. Juli 2017

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Creative Commons BY-NC 3.0

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    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 26) CRFs Roche FVF4168G Macular Edema NCT00473330

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 26) CRFs Roche FVF4168G Macular Edema NCT00473330

    Patient administration
    Beschreibung

    Patient administration

    Subject Number
    Beschreibung

    PT

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Beschreibung

    PTINIT

    Datentyp

    text

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

    VDT

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 26)
    Beschreibung

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 26)

    Eye Treated:
    Beschreibung

    EYE (EYE)

    Datentyp

    integer

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

    TX_RECEIVED (TXREC)

    Datentyp

    boolean

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

    If Yes,

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1115660
    Date Administered:
    Beschreibung

    TREATMENT_DATE (TXDT, TXDTF)

    Datentyp

    date

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

    TIME_ADMINISTERED (TXTM)

    Datentyp

    time

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

    LIDOCAINE (LDCON)

    Datentyp

    boolean

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

    ANTIBIOTICS_CURRENT (ABXCR)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003232

    Ähnliche Modelle

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 26) CRFs Roche FVF4168G Macular Edema NCT00473330

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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 26)
    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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