0 Evaluaciones
ID

23308

Descripción

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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Versiones (1)
  1. 2/7/17 2/7/17 -
Titular de derechos de autor

Genentech, Inc.

Subido en

2 de julio de 2017

DOI

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Licencia

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

    Inglés

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

    1 formularios  
    Patient administration
    Descripción

    Patient administration

    Subject Number
    Descripción

    PT

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Descripción

    PTINIT

    Tipo de datos

    text

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

    VDT

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)
    Descripción

    RANIBIZUMAB ADMINISTRATION FELLOW EYE (MONTH 30)

    Eye Treated:
    Descripción

    EYE (EYE)

    Tipo de datos

    integer

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

    TX_RECEIVED (TXREC)

    Tipo de datos

    boolean

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

    If Yes,

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1115660
    Date Administered:
    Descripción

    TREATMENT_DATE (TXDT, TXDTF)

    Tipo de datos

    date

    Unidades de medida
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C1566537
    UMLS CUI [1,2]
    C0011008
    DD/MMM/YY
    Time Administered:
    Descripción

    TIME_ADMINISTERED (TXTM)

    Tipo de datos

    time

    Unidades de medida
    • 24 hr clock
    Alias
    UMLS CUI [1,1]
    C1566537
    UMLS CUI [1,2]
    C0011008
    24 hr clock
    Was lidocaine injection administered?
    Descripción

    LIDOCAINE (LDCON)

    Tipo de datos

    boolean

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

    ANTIBIOTICS_CURRENT (ABXCR)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0003232
    Volver a la parte superior de la página

    Similar models

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

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Volver a la parte superior de la página 

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