ID

22692

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 #: 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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Versions (1)
  1. 6/9/17 6/9/17 -
Copyright Holder

Genentech, Inc.

Uploaded on

June 9, 2017

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Creative Commons BY-NC 3.0
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    FOLLOW-UP CONTACT DAY 0 CRFs Roche FVF4170G Macular Edema NCT00473382

    English

    FOLLOW-UP CONTACT DAY 0 CRFs Roche FVF4170G Macular Edema NCT00473382

    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
    FOLLOW-UP CONTACT (DAY 0)
    Description

    FOLLOW-UP CONTACT (DAY 0)

    Was the subject contacted 2-4 days after study treatment?
    Description

    CONTACT [CONTAC]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1705415
    UMLS CUI [1,2]
    C2709088
    Date of Contact:
    Description

    CONTACT_DT [CONDT]

    Data type

    date

    Measurement units
    • DD/MMM/YY
    Alias
    UMLS CUI [1,1]
    C1705415
    UMLS CUI [1,2]
    C0011008
    DD/MMM/YY
    Has the subject been taking the prescribed self-administered post-injection antimicrobials?
    Description

    Note: If Yes was answered to any of the questions below, the subject should return as soon as possible to the clinic for a safety assessment. Record on AE or SAE CRF if appropriate.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0338237
    Decrease in Vision: Has the subject experienced a decrease in vision in the study eye since treatment?
    Description

    VISION_DECREASED [VSNDEC]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4280600
    Eye Pain: Has the subject had any eye pain in the study eye since treatment?
    Description

    EYE_PAIN [EYEPN]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151827
    Unusual Redness: Has the subject had any new or unusual redness in the study eye (other than localized redness at the injection site) since treatment?
    Description

    EYE_REDNESS [EYERED]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0235267
    New Ocular Symptoms: Has the subject experienced any other new ocular symptoms in the study eye since treatment?
    Description

    NEW_SYMPTOM [NEWSX]

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0586406
    Safety Assessment Visit: Was the subject asked to return to the clinic for a safety assessment visit?
    Description

    ASSESSMENT_DONE [ASMTDN]

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0589121
    UMLS CUI [1,2]
    C0549076
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    Similar models

    FOLLOW-UP CONTACT DAY 0 CRFs Roche FVF4170G Macular Edema NCT00473382

    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
    FOLLOW-UP CONTACT (DAY 0)
    CONTACT [CONTAC]
    Item
    Was the subject contacted 2-4 days after study treatment?
    boolean
    C1705415 (UMLS CUI [1,1])
    C2709088 (UMLS CUI [1,2])
    CONTACT_DT [CONDT]
    Item
    Date of Contact:
    date
    C1705415 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    ANTIBIOTICS_CURRENT [ABXCR]
    Item
    Has the subject been taking the prescribed self-administered post-injection antimicrobials?
    boolean
    C0338237 (UMLS CUI [1])
    VISION_DECREASED [VSNDEC]
    Item
    Decrease in Vision: Has the subject experienced a decrease in vision in the study eye since treatment?
    boolean
    C4280600 (UMLS CUI [1])
    EYE_PAIN [EYEPN]
    Item
    Eye Pain: Has the subject had any eye pain in the study eye since treatment?
    boolean
    C0151827 (UMLS CUI [1])
    EYE_REDNESS [EYERED]
    Item
    Unusual Redness: Has the subject had any new or unusual redness in the study eye (other than localized redness at the injection site) since treatment?
    boolean
    C0235267 (UMLS CUI [1])
    NEW_SYMPTOM [NEWSX]
    Item
    New Ocular Symptoms: Has the subject experienced any other new ocular symptoms in the study eye since treatment?
    boolean
    C0586406 (UMLS CUI [1])
    ASSESSMENT_DONE [ASMTDN]
    Item
    Safety Assessment Visit: Was the subject asked to return to the clinic for a safety assessment visit?
    boolean
    C0589121 (UMLS CUI [1,1])
    C0549076 (UMLS CUI [1,2])
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