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ID

23210

Description

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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Versions (2)
  1. 6/28/17 6/28/17 -
  2. 7/1/17 7/1/17 -
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June 28, 2017

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Creative Commons BY-NC 3.0 Legacy
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    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

    English

    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms  
    Patient administration
    Description

    Patient administration

    Subject Number
    Description

    PT

    Data type

    integer

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

    PTINIT

    Data type

    text

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

    VDT

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302584 (Date of report)
    SNOMED
    399651003
    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
    Description

    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)

    Indicate if the subject completed the study drug treatment or discontinued early (check one only):
    Description

    TX_DRUG_DISC [TXDISC]

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826674 (Study Treatment Course Completion Occurrence)
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    Similar models

    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)CRFs Roche FVF4168G Macular Edema NCT00473330

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    STUDY DRUG TREATMENT COMPLETION / EARLY DISCONTINUATION (UNSCHEDULED)
    Item
    Indicate if the subject completed the study drug treatment or discontinued early (check one only):
    integer
    C2826674 (UMLS CUI [1])
    TX_DRUG_DISC [TXDISC]
    Code List
    Indicate if the subject completed the study drug treatment or discontinued early (check one only):
    CL Item
    Subject Completed Study Drug Treatment (1)
    CL Item
    Subject Discontinued Study Drug Treatment Early (2)
    Back to the top of the page 

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