0 Evaluaciones
ID

33367

Descripción

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Palabras clave

Versiones (2)
  1. 06/11/2018 06/11/2018 -
  2. 06/12/2018 06/12/2018 -
Titular de derechos de autor

GSK group of companies

Subido en

6 décembre 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

    Inglés

    Study conclusion

    1 formularios  
    1. StudyEvent: ODM
      1. Study conclusion
    Study conclusion details
    Descripción

    Study conclusion details

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Date of subject completion or withdrawal
    Descripción

    Date of subject completion or withdrawal

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2983670
    Was the subject withdrawn from the study?
    Descripción

    Was the subject withdrawn from the study?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    If YES, complete primary reason for withdrawal
    Descripción

    If YES, complete primary reason for withdrawal

    Alias
    UMLS CUI-1
    C0422727
    UMLS CUI-2
    C0392360
    1. Adverse event
    Descripción

    record details on AE or SAE forms as appropriate)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    2. Lack of efficacy
    Descripción

    Check all that apply. If none, select "No Subreasons"

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0235828
    3. Protocol Deviation
    Descripción

    Check all that apply. If none, select "No Subreasons"

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1705236
    4. Subject reached protocol defined stopping criteria
    Descripción

    4. Subject reached protocol defined stopping criteria

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2746065
    UMLS CUI [1,2]
    C0243161
    5. Study closed/terminated
    Descripción

    5. Study closed/terminated

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2348570
    6. Lost to Follow-Up
    Descripción

    6. Lost to Follow-Up

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1302313
    7. Investigator discretion, specify
    Descripción

    Select this reason if none of the other primary reasons are appropriate

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0022423
    UMLS CUI [1,3]
    C2348235
    8. Withdrew consent, specify
    Descripción

    Select this reason if none of the other primary reasons are appropriate

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C2348235
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    Similar models

    Study conclusion

    1 formularios
    1. StudyEvent: ODM
      1. Study conclusion
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Study conclusion details
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    Was the subject withdrawn from the study?
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item Group
    If YES, complete primary reason for withdrawal
    C0422727 (UMLS CUI-1)
    C0392360 (UMLS CUI-2)
    1. Adverse event
    Item
    1. Adverse event
    boolean
    C0877248 (UMLS CUI [1])
    Item
    2. Lack of efficacy
    text
    C0235828 (UMLS CUI [1])
    2. Lack of efficacy
    Code List
    2. Lack of efficacy
    CL Item
    No subreasons (1)
    CL Item
    Exacerbation (2)
    Item
    3. Protocol Deviation
    text
    C1705236 (UMLS CUI [1])
    3. Protocol Deviation
    Code List
    3. Protocol Deviation
    CL Item
    No subreasons (1)
    CL Item
    Pregnancy (2)
    CL Item
    Lack of adherence (3)
    CL Item
    Prohibited medication use (4)
    Item
    4. Subject reached protocol defined stopping criteria
    text
    C2746065 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    Subject reached protocol defined stopping criteria
    Code List
    4. Subject reached protocol defined stopping criteria
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Liver function test abnormality (3)
    5. Study closed/terminated
    Item
    5. Study closed/terminated
    boolean
    C2348570 (UMLS CUI [1])
    6. Lost to Follow-Up
    Item
    6. Lost to Follow-Up
    boolean
    C1302313 (UMLS CUI [1])
    7. Investigator discretion, specify
    Item
    7. Investigator discretion, specify
    text
    C0008961 (UMLS CUI [1,1])
    C0022423 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    8. Withdrew consent, specify
    Item
    8. Withdrew consent, specify
    text
    C1707492 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Volver a la parte superior de la página 

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