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ID

28975

Description

Study part: Study Completion/ Early Discontinuation. A Phase III, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study Of The Efficacy And Safety Of rhuFab V2 (Ranibizumab) In Subjects With Minimally Classic Or Occult Subfoveal Neovascular Age-Related Macular Degeneration.

Keywords

Versions (1)
  1. 2/18/18 2/18/18 -
Copyright Holder

Roche

Uploaded on

February 18, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Study Completion/ Early Discontinuation rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

    English

    Study Completion/ Early Discontinuation

    1 forms  
    STUDY COMPLETION / EARLY DISCONTINUATION
    Description

    STUDY COMPLETION / EARLY DISCONTINUATION

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C0444930
    Subject Number:
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials:
    Description

    Subject Initials

    Data type

    text

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

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Did the subject complete the study through Month 24?
    Description

    Study Completion

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976
    UMLS CUI [1,2]
    C0444930
    If Yes, Date of Completion:
    Description

    Date of Completion

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0444930
    If No, Date of Early Discontinuation from study:
    Description

    Date of Early Discontinuation

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2718058
    PRIMARY reason the subject discontinued early from the study
    Description

    reason

    Data type

    text

    Alias
    UMLS CUI [1]
    C0392360
    Please specify intervention:
    Description

    Concomitant Therapy

    Data type

    text

    Alias
    UMLS CUI [1]
    C1707479
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    Similar models

    Study Completion/ Early Discontinuation

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    STUDY COMPLETION / EARLY DISCONTINUATION
    C0008976 (UMLS CUI-1)
    C0444930 (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])
    Study Completion
    Item
    Did the subject complete the study through Month 24?
    boolean
    C0008976 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    Date of Completion
    Item
    If Yes, Date of Completion:
    date
    C0011008 (UMLS CUI [1,1])
    C0444930 (UMLS CUI [1,2])
    Date of Early Discontinuation
    Item
    If No, Date of Early Discontinuation from study:
    date
    C0011008 (UMLS CUI [1,1])
    C2718058 (UMLS CUI [1,2])
    Item
    PRIMARY reason the subject discontinued early from the study
    text
    C0392360 (UMLS CUI [1])
    reason
    Code List
    PRIMARY reason the subject discontinued early from the study
    CL Item
    Death (complete Death Report and SAE CRF as appropriate) (Death (complete Death Report and SAE CRF as appropriate))
    C0011065 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Adverse Event (complete appropriate AE CRF) (Adverse Event (complete appropriate AE CRF))
    C0877248 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Lost to follow-up (Lost to follow-up)
    C1302313 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Subject’s decision to withdraw (for reasons other than AE) (Subject’s decision to withdraw (for reasons other than AE))
    C0422727 (UMLS CUI-1)
    C0679006 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Physician’s decision to withdraw (for reasons other than AE) (Physician’s decision to withdraw (for reasons other than AE))
    C1709536 (UMLS CUI-1)
    C2348571 (UMLS CUI-2)
    (Comment:en)
    CL Item
    Sponsor’s decision to terminate study (Sponsor’s decision to terminate study)
    C1710224 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Subject non-compliance (Subject non-compliance)
    C0457432 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Subject’s condition mandated other therapeutic intervention. (Subject’s condition mandated other therapeutic intervention.)
    C1707479 (UMLS CUI-1)
    (Comment:en)
    Concomitant Therapy
    Item
    Please specify intervention:
    text
    C1707479 (UMLS CUI [1])
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