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35132

Beschreibung

Study ID: 102970 Clinical Study ID: 102970 Study Title: 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: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

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Versionen (1)
  1. 19.02.19 19.02.19 -
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GlaxoSmithKline

Hochgeladen am

19. Februar 2019

DOI

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Creative Commons BY-NC 3.0
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    Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970

    Englisch

    Week 8

    1 Formulare  
    1. StudyEvent: ODM
      1. Week 8
    Administrative Data
    Beschreibung

    Administrative Data

    Site
    Beschreibung

    Study Site

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject
    Beschreibung

    Clinical trial participant

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C1997894
    Subject No.
    Beschreibung

    Clinical Trial Subject Unique Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Candidiasis Examination
    Beschreibung

    Candidiasis Examination

    Alias
    UMLS CUI-1
    C0006840
    UMLS CUI-2
    C4321457
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Beschreibung

    Oropharyngeal Candidiasis, Evidence

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0919659
    UMLS CUI [1,2]
    C3887511
    Was a culture swab taken?
    Beschreibung

    Oropharyngeal Candidiasis, Taking of swab

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0919659
    UMLS CUI [1,2]
    C0563454
    Result of culture swab
    Beschreibung

    Oropharyngeal Candidiasis, Taking of swab, Result

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0919659
    UMLS CUI [1,2]
    C0563454
    UMLS CUI [1,3]
    C1274040
    Smoking Status
    Beschreibung

    Smoking Status

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

    Smoking Status, Changed status

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1519386
    UMLS CUI [1,2]
    C0443172
    If yes, Smoking Status
    Beschreibung

    Smoking Status, Changed status

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1519386
    UMLS CUI [1,2]
    C0443172
    Date a change was made
    Beschreibung

    Smoking Status, Changed status, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1519386
    UMLS CUI [1,2]
    C0443172
    UMLS CUI [1,3]
    C0011008
    Date of Visit/Assessment
    Beschreibung

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of Visit/Assessment
    Beschreibung

    Date of Visit, Assessment Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Electronically Transferred Lab Data
    Beschreibung

    Electronically Transferred Lab Data

    Alias
    UMLS CUI-1
    C0022885
    Date sample taken
    Beschreibung

    Laboratory Procedures, Sampling, Date in time

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Not done
    Beschreibung

    Laboratory Procedures, Sampling, Not done

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1272696
    Liver Events Assessment
    Beschreibung

    Liver Events Assessment

    Alias
    UMLS CUI-1
    C0023884
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0220825
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Beschreibung

    Liver, Laboratory Procedures, Stop, Criteria

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0022885
    UMLS CUI [1,3]
    C2746065
    UMLS CUI [1,4]
    C0243161
    Subject Withdrawal Status
    Beschreibung

    Subject Withdrawal Status

    Alias
    UMLS CUI-1
    C0422727
    UMLS CUI-2
    C0449438
    Did the subject withdraw at this visit?
    Beschreibung

    Withdrawal by Subject, Visit

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677
    UMLS CUI [1,2]
    C0545082
    Pre-Dose Vital Signs
    Beschreibung

    Pre-Dose Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0439565
    Blood pressure (systolic)
    Beschreibung

    Systolic Pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure (diastolic)
    Beschreibung

    Diastolic blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Week 8

    1 Formulare
    1. StudyEvent: ODM
      1. Week 8
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    Study Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Clinical trial participant
    Item
    Subject
    text
    C1997894 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Subject No.
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Candidiasis Examination
    C0006840 (UMLS CUI-1)
    C4321457 (UMLS CUI-2)
    Oropharyngeal Candidiasis, Evidence
    Item
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    boolean
    C0919659 (UMLS CUI [1,1])
    C3887511 (UMLS CUI [1,2])
    Oropharyngeal Candidiasis, Taking of swab
    Item
    Was a culture swab taken?
    boolean
    C0919659 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    Item
    Result of culture swab
    text
    C0919659 (UMLS CUI [1,1])
    C0563454 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    Oropharyngeal Candidiasis, Taking of swab, Result
    Code List
    Result of culture swab
    CL Item
    Negative (1)
    CL Item
    Positive (2)
    CL Item
    Not available (3)
    Item Group
    Smoking Status
    C1519386 (UMLS CUI-1)
    Smoking Status, Changed status
    Item
    Has the smoking status changed since the last time it was assessed?
    boolean
    C1519386 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Item
    If yes, Smoking Status
    text
    C1519386 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Smoking Status, Changed status
    Code List
    If yes, Smoking Status
    CL Item
    Subject started smoking  (1)
    CL Item
    Subject stopped smoking (2)
    Smoking Status, Changed status, Date in time
    Item
    Date a change was made
    date
    C1519386 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of Visit, Assessment Date
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Electronically Transferred Lab Data
    C0022885 (UMLS CUI-1)
    Laboratory Procedures, Sampling, Date in time
    Item
    Date sample taken
    date
    C0022885 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Laboratory Procedures, Sampling, Not done
    Item
    Not done
    boolean
    C0022885 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Item Group
    Liver Events Assessment
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Liver, Laboratory Procedures, Stop, Criteria
    Item
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    boolean
    C0023884 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    C2746065 (UMLS CUI [1,3])
    C0243161 (UMLS CUI [1,4])
    Item Group
    Subject Withdrawal Status
    C0422727 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Withdrawal by Subject, Visit
    Item
    Did the subject withdraw at this visit?
    boolean
    C1710677 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    Item Group
    Pre-Dose Vital Signs
    C0518766 (UMLS CUI-1)
    C0439565 (UMLS CUI-2)
    Systolic Pressure
    Item
    Blood pressure (systolic)
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood Pressure (diastolic)
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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