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ID

35134

Beschrijving

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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Versies (1)
  1. 19-02-19 19-02-19 -
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GlaxoSmithKline

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19 februari 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

    Engels

    Week 20

    1 Formulieren  
    1. StudyEvent: ODM
      1. Week 20
    Administrative Data
    Beschrijving

    Administrative Data

    Site
    Beschrijving

    Study Site

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Subject
    Beschrijving

    Clinical trial participant

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1997894 (Clinical trial participant (person))
    SNOMED
    428024001
    Subject No.
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Candidiasis Examination
    Beschrijving

    Candidiasis Examination

    Alias
    UMLS CUI-1
    C0006840 (Candidiasis)
    SNOMED
    78048006
    UMLS CUI-2
    C4321457 (Examination)
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Beschrijving

    Oropharyngeal Candidiasis, Evidence

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0919659 (Oropharyngeal candidiasis)
    UMLS CUI [1,2]
    C3887511 (Evidence)
    Was a culture swab taken?
    Beschrijving

    Oropharyngeal Candidiasis, Taking of swab

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0919659 (Oropharyngeal candidiasis)
    UMLS CUI [1,2]
    C0563454 (Taking of swab)
    SNOMED
    285570007
    Result of culture swab
    Beschrijving

    Oropharyngeal Candidiasis, Taking of swab, Result

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0919659 (Oropharyngeal candidiasis)
    UMLS CUI [1,2]
    C0563454 (Taking of swab)
    SNOMED
    285570007
    UMLS CUI [1,3]
    C1274040 (Result)
    SNOMED
    394617004
    Smoking Status
    Beschrijving

    Smoking Status

    Alias
    UMLS CUI-1
    C1519386 (Smoking Status)
    Has the smoking status changed since the last time it was assessed?
    Beschrijving

    Smoking Status, Changed status

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1519386 (Smoking Status)
    UMLS CUI [1,2]
    C0443172 (Changed status)
    SNOMED
    263703002
    If yes, Smoking Status
    Beschrijving

    Smoking Status, Changed status

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1519386 (Smoking Status)
    UMLS CUI [1,2]
    C0443172 (Changed status)
    SNOMED
    263703002
    Date a change was made
    Beschrijving

    Smoking Status, Changed status, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1519386 (Smoking Status)
    UMLS CUI [1,2]
    C0443172 (Changed status)
    SNOMED
    263703002
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Date of Visit/Assessment
    Beschrijving

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI-2
    C2985720 (Assessment Date)
    Date of Visit/Assessment
    Beschrijving

    Date of Visit, Assessment Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    UMLS CUI [1,2]
    C2985720 (Assessment Date)
    Electronically Transferred Lab Data
    Beschrijving

    Electronically Transferred Lab Data

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    Date sample taken
    Beschrijving

    Laboratory Procedures, Sampling, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [1,2]
    C0870078 (Sampling)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Not done
    Beschrijving

    Laboratory Procedures, Sampling, Not done

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [1,2]
    C0870078 (Sampling)
    UMLS CUI [1,3]
    C1272696 (Not Done)
    SNOMED
    385660001
    Liver Events Assessment
    Beschrijving

    Liver Events Assessment

    Alias
    UMLS CUI-1
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI-2
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI-3
    C0220825 (Evaluation)
    LOINC
    LP36377-7
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Beschrijving

    Liver, Laboratory Procedures, Stop, Criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023884 (Liver)
    SNOMED
    10200004
    LOINC
    LP29289-3
    UMLS CUI [1,2]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [1,3]
    C2746065 (Stop (qualifier value))
    SNOMED
    422117008
    UMLS CUI [1,4]
    C0243161 (criteria)
    Subject Withdrawal Status
    Beschrijving

    Subject Withdrawal Status

    Alias
    UMLS CUI-1
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI-2
    C0449438 (Status)
    SNOMED
    263490005
    LOINC
    LP73412-6
    Did the subject withdraw at this visit?
    Beschrijving

    Withdrawal by Subject, Visit

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1710677 (Withdrawal by Subject)
    UMLS CUI [1,2]
    C0545082 (Visit)
    Pre-Dose Vital Signs
    Beschrijving

    Pre-Dose Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    UMLS CUI-2
    C0439565 (Pre-dose)
    SNOMED
    255235001
    Blood pressure (systolic)
    Beschrijving

    Systolic Pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Blood Pressure (diastolic)
    Beschrijving

    Diastolic blood pressure

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

    Maateenheden
    • bpm
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    bpm
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    Similar models

    Week 20

    1 Formulieren
    1. StudyEvent: ODM
      1. Week 20
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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])
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