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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. 04/06/2017 04/06/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

4 juin 2017

DOI

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Licence

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

    Anglais

    HES History or Prior HES Therapies Screening Visit

    1 Formulaires  
    DIAGNOSIS
    Description

    DIAGNOSIS

    Alias
    UMLS CUI-1
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    Subject ID
    Description

    Subject ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Year of diagnosis of HES
    Description

    year of diagnosis Hypereosinophilic Syndrome

    Type de données

    partialDate

    Alias
    UMLS CUI [1,1]
    C0439234 (year)
    SNOMED
    258707000
    UMLS CUI [1,2]
    C0011900 (Diagnosis)
    SNOMED
    439401001
    LOINC
    LP30831-9
    UMLS CUI [1,3]
    C1540912 (Hypereosinophilic syndrome)
    SNOMED
    128835008
    HISTORY OF HES THERAPY
    Description

    HISTORY OF HES THERAPY

    Alias
    UMLS CUI-1
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI-2
    C1540912 (Hypereosinophilic syndrome)
    SNOMED
    128835008
    Has the subject received any of the below therapies for HES within 5 years prior to the Screening Visit?
    Description

    Therapy HES

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C1540912 (Hypereosinophilic syndrome)
    SNOMED
    128835008
    Interferon α
    Description

    Interferon alpha

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0002199 (Interferon-alpha)
    SNOMED
    45754009
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Hydroxyurea
    Description

    Hydroxyurea

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0020402 (hydroxyurea)
    SNOMED
    56602009
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Cyclosporin
    Description

    Cyclosporin

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0010592 (cyclosporine)
    SNOMED
    387467008
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Cyclophosphomide
    Description

    Cyclophosphamide

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0010583 (cyclophosphamide)
    SNOMED
    74470007
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Imatinib Mesylate
    Description

    Imatinib Mesylate

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0939537 (imatinib mesylate)
    SNOMED
    129558005
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Methotrexate
    Description

    Methotrexate

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0025677 (methotrexate)
    SNOMED
    68887009
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Vincristine
    Description

    Vincristine

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0042679 (vincristine)
    SNOMED
    23079006
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Busulfan
    Description

    Busulfan

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006463 (busulfan)
    SNOMED
    2571007
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Chlorambucil
    Description

    Chlorambucil

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0008163 (chlorambucil)
    SNOMED
    46009007
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Immunotherapy (other monoclonal antibodies or anti-T cell therapies eg., TNF α inhibitors, alefacept)
    Description

    Immunotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021083 (Immunotherapy)
    SNOMED
    76334006
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Systemic Corticosteroid(s)
    Description

    Systemic Corticosteroid

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C4039704 (History of systemic steroid therapy)
    SNOMED
    134671000119104
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Other (specify):
    Description

    Other

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    Reason for Treatment Discontinuation
    Description

    Reason Treatment Discontinuation

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0677162 (Recommend therapy discontinuation)
    Retour au début de la page

    Similar models

    HES History or Prior HES Therapies Screening Visit

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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)
    Retour au début de la page 

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