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ID

22460

Description

Study part: PGx- Pharmacogenetic Research.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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Versions (1)
  1. 6/5/17 6/5/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 5, 2017

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Creative Commons BY-NC 3.0
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    Pharmacogenetic Research Mepolizumab HES NCT00086658

    English

    PGx- Pharmacogenetic Research

    1 forms  
    CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
    Description

    CONSENT FOR PGx-PHARMACOGENETIC RESEARCH

    Alias
    UMLS CUI-1
    C0021430 (Informed Consent)
    UMLS CUI-2
    C2347500 (Pharmacogenetic Test)
    Study ID
    Description

    Study ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826693 (Study Identifier)
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Description

    informed consent Pharmacogenetic Test

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    If Yes,the date informed consent obtained for PGx-Pharmacogenetic research
    Description

    date Pharmacogenetic Test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    If No,reason:
    Description

    reason Pharmacogenetic Test

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    If other, please specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    BLOOD SAMPLE COLLECTION (DNA)
    Description

    BLOOD SAMPLE COLLECTION (DNA)

    Alias
    UMLS CUI-1
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Has a blood sample been collected for PGx-pharmacogenetic research?
    Description

    BLOOD SAMPLE COLLECTION

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    If Yes, the date sample taken
    Description

    date BLOOD SAMPLE COLLECTION

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    WITHDRAWAL OF CONSENT
    Description

    WITHDRAWAL OF CONSENT

    Alias
    UMLS CUI-1
    C1707492 (Consent Withdrawn)
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Description

    WITHDRAWAL OF CONSENT

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707492 (Consent Withdrawn)
    BLOOD SAMPLE DESTRUCTION
    Description

    BLOOD SAMPLE DESTRUCTION

    Alias
    UMLS CUI-1
    C1948029 (Destruction (action))
    UMLS CUI-2
    C0178913 (Blood specimen)
    SNOMED
    119297000
    Has a request been made for sample destruction?
    Description

    BLOOD SAMPLE DESTRUCTION

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029 (Destruction (action))
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    If Yes,reason:
    Description

    reason BLOOD SAMPLE DESTRUCTION

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C1948029 (Destruction (action))
    UMLS CUI [1,3]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    If other, please specify
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Back to the top of the page

    Similar models

    PGx- Pharmacogenetic Research

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    CONSENT FOR PGx-PHARMACOGENETIC RESEARCH
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Study ID
    Item
    Study ID
    text
    C2826693 (UMLS CUI [1])
    informed consent Pharmacogenetic Test
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    date Pharmacogenetic Test
    Item
    If Yes,the date informed consent obtained for PGx-Pharmacogenetic research
    date
    C0011008 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Item
    If No,reason:
    text
    C0392360 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    reason
    Code List
    If No,reason:
    CL Item
    Subject declined (Subject declined)
    CL Item
    Subject not asked by Investigator (Subject not asked by Investigator)
    CL Item
    Other, specify (Other, specify)
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
    Item Group
    BLOOD SAMPLE COLLECTION (DNA)
    C0005834 (UMLS CUI-1)
    BLOOD SAMPLE COLLECTION
    Item
    Has a blood sample been collected for PGx-pharmacogenetic research?
    boolean
    C0005834 (UMLS CUI [1])
    date BLOOD SAMPLE COLLECTION
    Item
    If Yes, the date sample taken
    date
    C0011008 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Item Group
    WITHDRAWAL OF CONSENT
    C1707492 (UMLS CUI-1)
    WITHDRAWAL OF CONSENT
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    boolean
    C1707492 (UMLS CUI [1])
    Item Group
    BLOOD SAMPLE DESTRUCTION
    C1948029 (UMLS CUI-1)
    C0178913 (UMLS CUI-2)
    BLOOD SAMPLE DESTRUCTION
    Item
    Has a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    Item
    If Yes,reason:
    text
    C0392360 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    reason BLOOD SAMPLE DESTRUCTION
    Code List
    If Yes,reason:
    CL Item
    Subject requested (Subject requested)
    CL Item
    Screen failure (Screen failure)
    C1710476 (UMLS CUI-1)
    CL Item
    Other, specify (Other, specify)
    C0205394 (UMLS CUI-1)
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
    Back to the top of the page 

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