ID

22448

Descripción

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.

Palabras clave

Versiones (1)
  1. 4/6/17 4/6/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de junio de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    HES History or Prior HES Therapies Screening Visit Mepolizumab HES NCT00086658

    Inglés

    HES History or Prior HES Therapies Screening Visit

    1 formularios  
    DIAGNOSIS
    Descripción

    DIAGNOSIS

    Alias
    UMLS CUI-1
    C0011900
    Subject ID
    Descripción

    Subject ID

    Tipo de datos

    text

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

    year of diagnosis Hypereosinophilic Syndrome

    Tipo de datos

    partialDate

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

    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?
    Descripción

    Therapy HES

    Tipo de datos

    boolean

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

    Interferon alpha

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Hydroxyurea

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Cyclosporin

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Cyclophosphamide

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Imatinib Mesylate

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Methotrexate

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Vincristine

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Busulfan

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Chlorambucil

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    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)
    Descripción

    Immunotherapy

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Systemic Corticosteroid

    Tipo de datos

    boolean

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

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

    Other

    Tipo de datos

    text

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

    Reason Treatment Discontinuation

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0677162
    Volver a la parte superior de la página

    Similar models

    HES History or Prior HES Therapies Screening Visit

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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)
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial