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35257

Descrizione

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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versioni (1)
  1. 25/02/19 25/02/19 -
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GlaxoSmithKline

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25 febbraio 2019

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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

    Inglese

    End of Study

    1 moduli  
    1. StudyEvent: ODM
      1. End of Study
    Administrative Data
    Descrizione

    Administrative Data

    Site
    Descrizione

    Study Site

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject
    Descrizione

    Clinical trial participant

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1997894
    Subject No.
    Descrizione

    Clinical Trial Subject Unique Identifier

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Status of Treatment Blind
    Descrizione

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C2347038
    UMLS CUI-2
    C0449438
    Was the treatment blind broken during the study?
    Descrizione

    If yes, complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product forms as appropriate

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Date blind broken
    Descrizione

    Subject Unblinding Event Record, Date in time

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0011008
    Reason blind broken
    Descrizione

    Subject Unblinding Event Record, Indication

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Follow-Up Contact
    Descrizione

    Follow-Up Contact

    Alias
    UMLS CUI-1
    C1522577
    Subject contacted for follow-up?
    Descrizione

    Follow-up, Contact with, Study subject

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1522577
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C0681850
    Date of Visit/Assessment
    Descrizione

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303
    UMLS CUI-2
    C2985720
    Date of visit/assessment
    Descrizione

    Date of visit, Assessment Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Study Conclusion
    Descrizione

    Study Conclusion

    Alias
    UMLS CUI-1
    C0008976
    UMLS CUI-2
    C1707478
    Date of subject completion or withdrawal
    Descrizione

    Study End Date, Patient withdrawn from trial, Date in time

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C2983670
    UMLS CUI [1,2]
    C0422727
    UMLS CUI [1,3]
    C0011008
    Was the subject withdrawn from the study?
    Descrizione

    Patient withdrawn from trial

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    Primary reason for withdrawal
    Descrizione

    Patient withdrawn from trial, Indication

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C3146298
    Investigational Product - Double Blind
    Descrizione

    Investigational Product - Double Blind

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0013072
    Start Date
    Descrizione

    Experimental drug, Double-Blind Method, Start Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0013072
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C0808070
    Stop Date
    Descrizione

    Experimental drug, Double-Blind Method, End Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0013072
    UMLS CUI [1,2]
    C0808070
    UMLS CUI [1,3]
    C0806020
    Pharmacogenetic (PGx) Research Withdrawal of Consent
    Descrizione

    Pharmacogenetic (PGx) Research Withdrawal of Consent

    Alias
    UMLS CUI-1
    C0031325
    UMLS CUI-2
    C1707492
    Has subject withdrawn consent for PGx research?
    Descrizione

    Pharmacogenetics, Consent Withdrawn

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C1707492
    Yes, date informed consent withdrawn
    Descrizione

    Pharmacogenetics, Consent Withdrawn, Date in time

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C1707492
    UMLS CUI [1,3]
    C0011008
    Has a request been made for sample destruction?
    Descrizione

    Pharmacogenetics, Blood Specimen, Destruction, Request

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C1272683
    Yes, check reason
    Descrizione

    Pharmacogenetics, Blood Specimen, Destruction, Request, Indication

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1948029
    UMLS CUI [1,4]
    C1272683
    UMLS CUI [1,5]
    C3146298
    Investigator Signature
    Descrizione

    Investigator Signature

    Alias
    UMLS CUI-1
    C2346576
    Is this casebook ready to sign?
    Descrizione

    Investigator Signature

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2346576
    Pregnancy Information
    Descrizione

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    UMLS CUI-2
    C1533716
    Did the subject become pregnant during the study?
    Descrizione

    Pregnant during the study

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3828490
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    End of Study

    1 moduli
    1. StudyEvent: ODM
      1. End of Study
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    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
    Status of Treatment Blind
    C2347038 (UMLS CUI-1)
    C0449438 (UMLS CUI-2)
    Subject Unblinding Event Record
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Subject Unblinding Event Record, Date in time
    Item
    Date blind broken
    date
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason blind broken
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Subject Unblinding Event Record, Indication
    Code List
    Reason blind broken
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other, specify (2)
    Item Group
    Follow-Up Contact
    C1522577 (UMLS CUI-1)
    Follow-up, Contact with, Study subject
    Item
    Subject contacted for follow-up?
    boolean
    C1522577 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C0681850 (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
    Study Conclusion
    C0008976 (UMLS CUI-1)
    C1707478 (UMLS CUI-2)
    Study End Date, Patient withdrawn from trial, Date in time
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1,1])
    C0422727 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Patient withdrawn from trial
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Primary reason for withdrawal
    text
    C0422727 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Patient withdrawn from trial, Indication
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lack of efficacy  (2)
    CL Item
    Exacerbation (3)
    CL Item
    Protocol Deviation (4)
    CL Item
    Subject reached protocol defined stopping criteria  (5)
    CL Item
    Study closed/terminated (6)
    CL Item
    Lost to Follow-up (7)
    CL Item
    Withdrew consent (8)
    CL Item
    Investigator discretion, specify (9)
    Item Group
    Investigational Product - Double Blind
    C0304229 (UMLS CUI-1)
    C0013072 (UMLS CUI-2)
    Experimental drug, Double-Blind Method, Start Date
    Item
    Start Date
    date
    C0013072 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C0808070 (UMLS CUI [1,3])
    Experimental drug, Double-Blind Method, End Date
    Item
    Stop Date
    date
    C0013072 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    C0806020 (UMLS CUI [1,3])
    Item Group
    Pharmacogenetic (PGx) Research Withdrawal of Consent
    C0031325 (UMLS CUI-1)
    C1707492 (UMLS CUI-2)
    Pharmacogenetics, Consent Withdrawn
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C0031325 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    Pharmacogenetics, Consent Withdrawn, Date in time
    Item
    Yes, date informed consent withdrawn
    date
    C2347500 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Pharmacogenetics, Blood Specimen, Destruction, Request
    Item
    Has a request been made for sample destruction?
    boolean
    C0031325 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    Item
    Yes, check reason
    text
    C0031325 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1948029 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    C3146298 (UMLS CUI [1,5])
    Pharmacogenetics, Blood Specimen, Destruction, Request, Indication
    Code List
    Yes, check reason
    CL Item
    Subject withdrew consent for PGx  (1)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (3)
    Item Group
    Investigator Signature
    C2346576 (UMLS CUI-1)
    Investigator Signature
    Item
    Is this casebook ready to sign?
    boolean
    C2346576 (UMLS CUI [1])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    Pregnant during the study
    Item
    Did the subject become pregnant during the study?
    boolean
    C3828490 (UMLS CUI [1])
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