ID

29535

Descrição

Study ID: 102871 Clinical Study ID: HZC102871 Study Title:HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01009463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Pulmonary Disease, Chronic Obstructive Documentation part: COPD Exacerbations

Palavras-chave

Versões (3)
  1. 04/03/2018 04/03/2018 -
  2. 05/04/2018 05/04/2018 -
  3. 05/04/2018 05/04/2018 -
Titular dos direitos

GlaxoSmithKline

Transferido a

5 de abril de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    GSK Efficacy and safety of Fluticasone on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) NCT01009463

    Inglês

    Week 8

    1 Formulários  
    1. StudyEvent: ODM
      1. Week 8
    Subject withdrawal
    Descrição

    Subject withdrawal

    Alias
    UMLS CUI-1
    C1710677
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0024117
    Date of visit/assessment
    Descrição

    Date of visit/assessment

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Did the subject withdraw at this visit?
    Descrição

    withdraw

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1710677
    Pre-Dose Vital Signs
    Descrição

    Pre-Dose Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439565
    Blood pressure systolic
    Descrição

    Blood pressure systolic

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure diastolic
    Descrição

    Blood pressure diastolic

    Tipo de dados

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Descrição

    Heart rate

    Tipo de dados

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Candidiasis examination
    Descrição

    Candidiasis examination

    Alias
    UMLS CUI-1
    C0006849
    UMLS CUI-2
    C0582103
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Descrição

    clinical evidence of oropharyngeal candidiasis

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0006849
    UMLS CUI [1,2]
    C3887511
    Was a swab taken?
    Descrição

    culture swab taken

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0563454
    UMLS CUI [1,2]
    C0006849
    Yes, result of culture swab
    Descrição

    result of culture swab

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0563454
    UMLS CUI [1,2]
    C1274040
    UMLS CUI [1,3]
    C0006849
    Electronically transferred lab data
    Descrição

    Electronically transferred lab data

    Alias
    UMLS CUI-1
    C0200345
    UMLS CUI-2
    C0022885
    UMLS CUI-3
    C1320722
    Sample taken?
    Descrição

    sample taken

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0200345
    Date sample taken
    Descrição

    Date sample taken

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1302413
    Liver Events Assessment
    Descrição

    Liver Events Assessment

    Alias
    UMLS CUI-1
    C0232741
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0220825
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Descrição

    liver chemistry results

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0587081
    Smoking Status
    Descrição

    Smoking Status

    Alias
    UMLS CUI-1
    C1519386
    UMLS CUI-2
    C0543414
    Has the smoking status changed since the last time it was assessed?
    Descrição

    smoking status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1519386
    If yes: Specify smoking status
    Descrição

    smoking status

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1519386
    Date a change was made
    Descrição

    date smoking status was changed

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1519386
    UMLS CUI [1,2]
    C0443172
    UMLS CUI [1,3]
    C0011008
    Voltar ao início da página

    Similar models

    Week 8

    1 Formulários
    1. StudyEvent: ODM
      1. Week 8
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Subject withdrawal
    C1710677 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C0024117 (UMLS CUI-3)
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    withdraw
    Item
    Did the subject withdraw at this visit?
    boolean
    C1710677 (UMLS CUI [1])
    Item Group
    Pre-Dose Vital Signs
    C0518766 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    Blood pressure systolic
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1])
    Blood pressure diastolic
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    Candidiasis examination
    C0006849 (UMLS CUI-1)
    C0582103 (UMLS CUI-2)
    Item
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    text
    C0006849 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    clinical evidence of oropharyngeal candidiasis
    Code List
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    culture swab taken
    Item
    Was a swab taken?
    boolean
    C0563454 (UMLS CUI [1,1])
    C0006849 (UMLS CUI [1,2])
    Item
    Yes, result of culture swab
    integer
    C0563454 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    C0006849 (UMLS CUI [1,3])
    oropharyngeal candidiasis test result
    Code List
    Yes, result of culture swab
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Not available (4)
    Item Group
    Electronically transferred lab data
    C0200345 (UMLS CUI-1)
    C0022885 (UMLS CUI-2)
    C1320722 (UMLS CUI-3)
    sample taken
    Item
    Sample taken?
    boolean
    C0200345 (UMLS CUI [1])
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item Group
    Liver Events Assessment
    C0232741 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    liver chemistry results
    Item
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    boolean
    C0232741 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [1,3])
    Item Group
    Smoking Status
    C1519386 (UMLS CUI-1)
    C0543414 (UMLS CUI-2)
    smoking status
    Item
    Has the smoking status changed since the last time it was assessed?
    boolean
    C1519386 (UMLS CUI [1])
    Item
    If yes: Specify smoking status
    integer
    C1519386 (UMLS CUI [1])
    smoking status
    Code List
    If yes: Specify smoking status
    CL Item
    Subject started smoking (1)
    CL Item
    Subject stopped smoking (2)
    date smoking status was changed
    Item
    Date a change was made
    date
    C1519386 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Voltar ao início da página 

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