ID

29536

Beschreibung

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: Early Withdrawal

Stichworte

Versionen (2)
  1. 15.03.18 15.03.18 -
  2. 05.04.18 05.04.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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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

    Englisch

    Early Withdrawal

    1 Formulare  
    1. StudyEvent: ODM
      1. Early Withdrawal
    Early Withdrawal
    Beschreibung

    Early Withdrawal

    Alias
    UMLS CUI-1
    C1710677 (Withdrawal by Subject)
    UMLS CUI-2
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI-3
    C0024117 (Chronic Obstructive Airway Disease)
    SNOMED
    13645005
    LOINC
    LP57616-2
    Date of visit/assessment
    Beschreibung

    Date of visit/assessment

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Pre-Dose Vital Signs
    Beschreibung

    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
    Beschreibung

    Blood pressure systolic

    Datentyp

    integer

    Maßeinheiten
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Blood pressure diastolic
    Beschreibung

    Blood pressure diastolic

    Datentyp

    integer

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

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    Candidiasis examination
    Beschreibung

    Candidiasis examination

    Alias
    UMLS CUI-1
    C0006849 (Oral candidiasis)
    SNOMED
    79740000
    UMLS CUI-2
    C0582103 (Medical Examination)
    SNOMED
    225886003
    Does the subject have clinical evidence of oropharyngeal candidiasis?
    Beschreibung

    clinical evidence of oropharyngeal candidiasis

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0006849 (Oral candidiasis)
    SNOMED
    79740000
    UMLS CUI [1,2]
    C3887511 (Evidence)
    Was a swab taken?
    Beschreibung

    culture swab taken

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0563454 (Taking of swab)
    SNOMED
    285570007
    UMLS CUI [1,2]
    C0006849 (Oral candidiasis)
    SNOMED
    79740000
    Yes, result of culture swab
    Beschreibung

    result of culture swab

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0563454 (Taking of swab)
    SNOMED
    285570007
    UMLS CUI [1,2]
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI [1,3]
    C0006849 (Oral candidiasis)
    SNOMED
    79740000
    Electronically transferred lab data
    Beschreibung

    Electronically transferred lab data

    Alias
    UMLS CUI-1
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI-2
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-3
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Sample taken?
    Beschreibung

    sample taken

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    Date sample taken
    Beschreibung

    Date sample taken

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Liver Events Assessment
    Beschreibung

    Liver Events Assessment

    Alias
    UMLS CUI-1
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    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?
    Beschreibung

    liver chemistry results

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [1,2]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,3]
    C0587081 (Laboratory test finding)
    SNOMED
    118246004
    Smoking Status
    Beschreibung

    Smoking Status

    Alias
    UMLS CUI-1
    C1519386 (Smoking Status)
    UMLS CUI-2
    C0543414 (Tobacco use)
    Has the smoking status changed since the last time it was assessed?
    Beschreibung

    smoking status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1519386 (Smoking Status)
    If yes: Specify smoking status
    Beschreibung

    smoking status

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1519386 (Smoking Status)
    Date a change was made
    Beschreibung

    date smoking status was changed

    Datentyp

    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
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Early Withdrawal

    1 Formulare
    1. StudyEvent: ODM
      1. Early Withdrawal
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Early 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])
    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])
    Zum Seitenanfang zurückkehren 

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