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ID

23259

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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Genentech, Inc.

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July 1, 2017

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Creative Commons BY-NC 3.0
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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
    Subject Initials:
    Description

    PTINIT

    Data type

    text

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

    VDT

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1302584
    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
    Date Subject Discontinued Study Drug Treatment Early:
    Description

    TX_DISCONTINUED_DT [TXDCDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C0558681
    UMLS CUI [1,2]
    C0011008
    DD/MMM/YY
    Check the PRIMARY reason the subject discontinued study drug treatment early
    Description

    TX_DRUG_DISC_REASON [TXREAS]

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0558681
    UMLS CUI [1,2]
    C0566251
    Please specify intervention:
    Description

    TX_DISC_REASON_SP [TXDCRS]

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0558681
    UMLS CUI [1,2]
    C0566251
    UMLS CUI [1,3]
    C0184661
    Back to the top of the page

    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)
    TX_DISCONTINUED_DT [TXDCDT]
    Item
    Date Subject Discontinued Study Drug Treatment Early:
    date
    C0558681 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Check the PRIMARY reason the subject discontinued study drug treatment early
    integer
    C0558681 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    TX_DRUG_DISC_REASON [TXREAS]
    Code List
    Check the PRIMARY reason the subject discontinued study drug treatment early
    CL Item
    Adverse Event (complete appropriate Adverse Event CRF) (1)
    CL Item
    Death (complete Study Completion / Early Discontinuation CRF) (2)
    CL Item
    Lost to follow-up (3)
    CL Item
    Physician’s decision to discontinue treatment (for reasons other than AE) (4)
    CL Item
    Subject’s decision to discontinue treatment (for reasons other than AE) (5)
    CL Item
    Sponsor’s decision to terminate study (6)
    CL Item
    Pregnancy (complete Pregnancy CRF) (7)
    CL Item
    Subject non-compliance (8)
    CL Item
    Subject’s condition mandated other therapeutic intervention (9)
    Item
    Please specify intervention:
    text
    C0558681 (UMLS CUI [1,1])
    C0566251 (UMLS CUI [1,2])
    C0184661 (UMLS CUI [1,3])
    TX_DRUG_DISC_REASON [TXREAS]
    Code List
    Please specify intervention:
    Back to the top of the page 

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