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ID

29367

Description

Study part: Prior Ocular Therapies And Procedures Screening. 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. 3/20/18 3/20/18 -
Copyright Holder

Roche

Uploaded on

March 20, 2018

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Creative Commons BY-NC 3.0
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    Prior Ocular Therapies And Procedures Screening Ranibizumab Macular Edema Diabetes Mellitus FVF4168g

    English

    Prior Ocular Therapies And Procedures Screening

    1 forms  
    PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING)
    Description

    PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING)

    Alias
    UMLS CUI-1
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI-2
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    Subject Number:
    Description

    Subject Number

    Data type

    text

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

    Subject Initials

    Data type

    text

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

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Any prior ocular therapies?
    Description

    Therapy eye

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0015392 (Eye)
    SNOMED
    81745001
    LOINC
    LP7218-3
    Name of Therapy
    Description

    Name of Therapy

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826274 (Treatment Name)
    Therapy Code
    Description

    Therapy Code

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0805701 (Code)
    Right Eye
    Description

    Right Eye

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0229089 (Right eye)
    SNOMED
    18944008
    LOINC
    LA16257-0
    Left Eye
    Description

    Left Eye

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0229090 (Left eye structure)
    SNOMED
    8966001
    LOINC
    LA14704-3
    Procedure /Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    Procedure / Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Check if ongoing
    Description

    Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
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    Similar models

    Prior Ocular Therapies And Procedures Screening

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    PRIOR OCULAR THERAPIES AND PROCEDURES (SCREENING)
    C0087111 (UMLS CUI-1)
    C0011849 (UMLS CUI-2)
    Subject Number
    Item
    Subject Number:
    text
    C2348585 (UMLS CUI [1])
    Subject Initials
    Item
    Subject Initials:
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date:
    date
    C1320303 (UMLS CUI [1])
    Therapy eye
    Item
    Any prior ocular therapies?
    boolean
    C0087111 (UMLS CUI [1,1])
    C0015392 (UMLS CUI [1,2])
    Name of Therapy
    Item
    Name of Therapy
    text
    C2826274 (UMLS CUI [1])
    Item
    Therapy Code
    text
    C0087111 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Therapy Code
    Code List
    Therapy Code
    CL Item
    Intravitreal Anti-VEGF Treatment (1)
    C0596087 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Intravitreal Steroids (2)
    C0038317 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Medication - Other (3)
    C1115771 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Supplements (4)
    C0242295 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Other (99)
    C0205394 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Laser, Focal or Grid Laser (5)
    C2945648 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Pan Retinal Photocoagulation (PRP) Laser (6)
    C0730064 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Vitrectomy (7)
    C0042903 (UMLS CUI-1)
    (Comment:en)
    Right Eye
    Item
    Right Eye
    boolean
    C0229089 (UMLS CUI [1])
    Left Eye
    Item
    Left Eye
    boolean
    C0229090 (UMLS CUI [1])
    Start Date
    Item
    Procedure /Start Date
    date
    C0808070 (UMLS CUI [1])
    Stop Date
    Item
    Procedure / Stop Date
    date
    C0806020 (UMLS CUI [1])
    Ongoing
    Item
    Check if ongoing
    boolean
    C0549178 (UMLS CUI [1])
    Back to the top of the page 

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