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ID

29537

Beskrivning

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: End of Study

Nyckelord

Versioner (2)
  1. 2018-03-15 2018-03-15 -
  2. 2018-04-05 2018-04-05 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 april 2018

DOI

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Licens

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

    Engelsk

    End of Study

    1 Formulär  
    1. StudyEvent: ODM
      1. End of Study
    Status of Treatment Blind
    Beskrivning

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    UMLS CUI-3
    C0024117
    Date of visit/assessment
    Beskrivning

    Date of visit/assessment

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Was the treatment blind broken during the study?
    Beskrivning

    treatment blind broken

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Date blind broken
    Beskrivning

    Date blind broken

    Datatyp

    integer

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

    Reason blind broken

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Reason blind broken, if other, specify
    Beskrivning

    Reason blind broken

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Pregnancy Information
    Beskrivning

    Pregnancy Information

    Alias
    UMLS CUI-1
    C0032961
    Did the subject become pregnant during the study?
    Beskrivning

    pregnant

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    Withdrawal of Consent for PGx (DNA)/Sample Destruction
    Beskrivning

    Withdrawal of Consent for PGx (DNA)/Sample Destruction

    Alias
    UMLS CUI-1
    C1707492
    UMLS CUI-2
    C1948029
    UMLS CUI-3
    C0178913
    Has subject withdrawn consent for PGx research?
    Beskrivning

    withdrawn consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1707492
    Yes, date informed consent withdrawn
    Beskrivning

    Date informed consent withdrawn

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1707492
    UMLS CUI [1,2]
    C0011008
    Ha a request been made for sample destruction?
    Beskrivning

    Sample destruction

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    Yes, check reason for sample destruction
    Beskrivning

    Reason for sample destruction

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0392360
    If Other Reason for sample destruction, specify
    Beskrivning

    Reason for sample destruction

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0392360
    Study Conclusion
    Beskrivning

    Study Conclusion

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

    Date of subject completion or withdrawal

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2983670
    Was the subject withdrawn from the study?
    Beskrivning

    subject withdrawn

    Datatyp

    boolean

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

    Primary reason for withdrawal

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0422727
    UMLS CUI [1,2]
    C0392360
    Subject contacted for follow-up?
    Beskrivning

    follow-up

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1522577
    UMLS CUI [1,2]
    C0332158
    UMLS CUI [1,3]
    C0681850
    Investigational Product - Double Blind
    Beskrivning

    Investigational Product - Double Blind

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0013072
    Double Blind Start Date
    Beskrivning

    Double Blind Start Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013072
    UMLS CUI [1,2]
    C0808070
    Double Blind Stop Date
    Beskrivning

    Double Blind Stop Date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0013072
    UMLS CUI [1,2]
    C0806020
    Is this casebook ready to sign? Investigator Signature
    Beskrivning

    Investigator Signature

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2346576
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    Similar models

    End of Study

    1 Formulär
    1. StudyEvent: ODM
      1. End of Study
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    C0024117 (UMLS CUI-3)
    Date of visit/assessment
    Item
    Date of visit/assessment
    date
    C1320303 (UMLS CUI [1])
    treatment blind broken
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Date blind broken
    Item
    Date blind broken
    integer
    C3897431 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Reason blind broken
    integer
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason blind broken
    Code List
    Reason blind broken
    CL Item
    Medical emergency requiring identification of investigational product for further treatment (1)
    CL Item
    Other, specify (2)
    Reason blind broken
    Item
    Reason blind broken, if other, specify
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Item Group
    Pregnancy Information
    C0032961 (UMLS CUI-1)
    pregnant
    Item
    Did the subject become pregnant during the study?
    boolean
    C0032961 (UMLS CUI [1])
    Item Group
    Withdrawal of Consent for PGx (DNA)/Sample Destruction
    C1707492 (UMLS CUI-1)
    C1948029 (UMLS CUI-2)
    C0178913 (UMLS CUI-3)
    withdrawn consent
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C1707492 (UMLS CUI [1])
    Date informed consent withdrawn
    Item
    Yes, date informed consent withdrawn
    date
    C1707492 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Sample destruction
    Item
    Ha a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    Item
    Yes, check reason for sample destruction
    integer
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Reason for sample destruction
    Code List
    Yes, check reason for sample destruction
    CL Item
    Subject withdrew consent for PGx (1)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (3)
    Reason for sample destruction
    Item
    If Other Reason for sample destruction, specify
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [1,3])
    Item Group
    Study Conclusion
    C1707478 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Date of subject completion or withdrawal
    Item
    Date of subject completion or withdrawal
    date
    C2983670 (UMLS CUI [1])
    subject withdrawn
    Item
    Was the subject withdrawn from the study?
    boolean
    C0422727 (UMLS CUI [1])
    Item
    Primary reason for withdrawal
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Primary reason for withdrawal
    Code List
    Primary reason for withdrawal
    CL Item
    Adverse Event (1)
    CL Item
    Lack of efficacy (2)
    CL Item
    Protocol Deviation (3)
    CL Item
    Subject reached protocol defined stopping criteria (4)
    CL Item
    Study closed/terminated (5)
    CL Item
    Lost to Follow-up (6)
    CL Item
    Withdrew consent (7)
    CL Item
    Investigator discretion, specify (8)
    follow-up
    Item
    Subject contacted for follow-up?
    boolean
    C1522577 (UMLS CUI [1,1])
    C0332158 (UMLS CUI [1,2])
    C0681850 (UMLS CUI [1,3])
    Item Group
    Investigational Product - Double Blind
    C0304229 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C0013072 (UMLS CUI-3)
    Double Blind Start Date
    Item
    Double Blind Start Date
    date
    C0013072 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Double Blind Stop Date
    Item
    Double Blind Stop Date
    date
    C0013072 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Investigator Signature
    Item
    Is this casebook ready to sign? Investigator Signature
    boolean
    C2346576 (UMLS CUI [1])
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