0 Bewertungen

ID

28975

Beschreibung

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.

Stichworte

  1. 18.02.18 18.02.18 -
Rechteinhaber

Roche

Hochgeladen am

18. Februar 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0

Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Itemgroup Kommentare für :

Item Kommentare für :


    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Study Completion/ Early Discontinuation rhuFab V2 Neovascular Age-Related Macular Degeneration FVF2598g

    Study Completion/ Early Discontinuation

    STUDY COMPLETION / EARLY DISCONTINUATION
    Beschreibung

    STUDY COMPLETION / EARLY DISCONTINUATION

    Alias
    UMLS CUI-1
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-2
    C0444930 (End)
    SNOMED
    261782000
    Subject Number:
    Beschreibung

    Subject Number

    Datentyp

    text

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

    Subject Initials

    Datentyp

    text

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

    Visit Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Did the subject complete the study through Month 24?
    Beschreibung

    Study Completion

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,2]
    C0444930 (End)
    SNOMED
    261782000
    If Yes, Date of Completion:
    Beschreibung

    Date of Completion

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0444930 (End)
    SNOMED
    261782000
    If No, Date of Early Discontinuation from study:
    Beschreibung

    Date of Early Discontinuation

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C2718058 (Early Termination of Clinical Trials)
    PRIMARY reason the subject discontinued early from the study
    Beschreibung

    reason

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Please specify intervention:
    Beschreibung

    Concomitant Therapy

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1707479 (Concomitant Therapy)

    Ähnliche Modelle

    Study Completion/ Early Discontinuation

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    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])

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video