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ID

22448

Description

Study part: HES History or Prior HES Therapies Screening Visit.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. 6/4/17 6/4/17 -
Copyright Holder

GlaxoSmithKline

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June 4, 2017

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Creative Commons BY-NC 3.0
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    HES History or Prior HES Therapies Screening Visit Mepolizumab HES NCT00086658

    English

    HES History or Prior HES Therapies Screening Visit

    1 forms  
    DIAGNOSIS
    Description

    DIAGNOSIS

    Alias
    UMLS CUI-1
    C0011900
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Year of diagnosis of HES
    Description

    year of diagnosis Hypereosinophilic Syndrome

    Data type

    partialDate

    Alias
    UMLS CUI [1,1]
    C0439234
    UMLS CUI [1,2]
    C0011900
    UMLS CUI [1,3]
    C1540912
    HISTORY OF HES THERAPY
    Description

    HISTORY OF HES THERAPY

    Alias
    UMLS CUI-1
    C0087111
    UMLS CUI-2
    C1540912
    Has the subject received any of the below therapies for HES within 5 years prior to the Screening Visit?
    Description

    Therapy HES

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1540912
    Interferon α
    Description

    Interferon alpha

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002199
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Hydroxyurea
    Description

    Hydroxyurea

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0020402
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Cyclosporin
    Description

    Cyclosporin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010592
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Cyclophosphomide
    Description

    Cyclophosphamide

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0010583
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Imatinib Mesylate
    Description

    Imatinib Mesylate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0939537
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Methotrexate
    Description

    Methotrexate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0025677
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Vincristine
    Description

    Vincristine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042679
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Busulfan
    Description

    Busulfan

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006463
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Chlorambucil
    Description

    Chlorambucil

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008163
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Immunotherapy (other monoclonal antibodies or anti-T cell therapies eg., TNF α inhibitors, alefacept)
    Description

    Immunotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021083
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Systemic Corticosteroid(s)
    Description

    Systemic Corticosteroid

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4039704
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Other (specify):
    Description

    Other

    Data type

    text

    Alias
    UMLS CUI [1]
    C0205394
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
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    Similar models

    HES History or Prior HES Therapies Screening Visit

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    DIAGNOSIS
    C0011900 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    year of diagnosis Hypereosinophilic Syndrome
    Item
    Year of diagnosis of HES
    partialDate
    C0439234 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    C1540912 (UMLS CUI [1,3])
    Item Group
    HISTORY OF HES THERAPY
    C0087111 (UMLS CUI-1)
    C1540912 (UMLS CUI-2)
    Therapy HES
    Item
    Has the subject received any of the below therapies for HES within 5 years prior to the Screening Visit?
    boolean
    C0087111 (UMLS CUI [1,1])
    C1540912 (UMLS CUI [1,2])
    Interferon alpha
    Item
    Interferon α
    boolean
    C0002199 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Hydroxyurea
    Item
    Hydroxyurea
    boolean
    C0020402 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Cyclosporin
    Item
    Cyclosporin
    boolean
    C0010592 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Cyclophosphamide
    Item
    Cyclophosphomide
    boolean
    C0010583 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Imatinib Mesylate
    Item
    Imatinib Mesylate
    boolean
    C0939537 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Methotrexate
    Item
    Methotrexate
    boolean
    C0025677 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Vincristine
    Item
    Vincristine
    boolean
    C0042679 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Busulfan
    Item
    Busulfan
    boolean
    C0006463 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Chlorambucil
    Item
    Chlorambucil
    boolean
    C0008163 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Immunotherapy
    Item
    Immunotherapy (other monoclonal antibodies or anti-T cell therapies eg., TNF α inhibitors, alefacept)
    boolean
    C0021083 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Systemic Corticosteroid
    Item
    Systemic Corticosteroid(s)
    boolean
    C4039704 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
    Other
    Item
    Other (specify):
    text
    C0205394 (UMLS CUI [1])
    Item
    Reason for Treatment Discontinuation
    text
    C0392360 (UMLS CUI [1,1])
    C0677162 (UMLS CUI [1,2])
    Reason Treatment Discontinuation
    Code List
    Reason for Treatment Discontinuation
    CL Item
    Lack of Efficacy (Lack of Efficacy)
    CL Item
    Adverse Event (Adverse Event)
    CL Item
    Treatment Related Toxicity (Treatment Related Toxicity)
    CL Item
    Unknown (Unknown)
    CL Item
    Ongoing (Ongoing)
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