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36475

Beschreibung

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

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GlaxoSmithKline

Hochgeladen am

16. Mai 2019

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    Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328

    Englisch

    Day 1 Pre-Dose -Vital Signs; Pharmacogenetic Research Consent/ Blood Sample Collection; Investigational Product Compliance (Pazopanib); Investigational Product (First Dose); Biomarker Samples

    1 Formulare  
    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

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Vital Signs
    Beschreibung

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual Date - Vital Signs
    Beschreibung

    Actual Date - Vital Signs

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826644
    Weight
    Beschreibung

    Weight

    Datentyp

    float

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Sitting Systolic blood pressure 1st reading
    Beschreibung

    Sitting Systolic blood pressure 1st reading

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C1319893
    mm[Hg]
    Sitting diastolic blood pressure 1st reading
    Beschreibung

    Sitting diastolic blood pressure 1st reading

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C1319894
    mm[Hg]
    Sitting Systolic blood pressure 2nd reading
    Beschreibung

    Sitting Systolic blood pressure 2nd reading

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C1319893
    mm[Hg]
    Sitting diastolic blood pressure 2nd reading
    Beschreibung

    Sitting diastolic blood pressure 2nd reading

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C1319894
    mm[Hg]
    Sitting Systolic blood pressure 3rd reading
    Beschreibung

    Sitting Systolic blood pressure 3rd reading

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C1319893
    mm[Hg]
    Sitting diastolic blood pressure 3rd reading
    Beschreibung

    Sitting diastolic blood pressure 3rd reading

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C1319894
    mm[Hg]
    Sitting Mean Systolic Blood pressure
    Beschreibung

    Sitting Mean Systolic Blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C1319893
    UMLS CUI [1,2]
    C0444504
    mm[Hg]
    Sitting Mean Diastolic Blood pressure
    Beschreibung

    Sitting Mean Diastolic Blood pressure

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C1319894
    UMLS CUI [1,2]
    C0444504
    mm[Hg]
    Heart rate
    Beschreibung

    Heart rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    Temperature
    Beschreibung

    Temperature

    Datentyp

    float

    Maßeinheiten
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Pharmacogenetic Research Consent/ Blood Sample Collection
    Beschreibung

    Pharmacogenetic Research Consent/ Blood Sample Collection

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C2347500
    UMLS CUI-3
    C0005834
    Has informed consent been obtained for PGx research?
    Beschreibung

    Has informed consent been obtained for PGx research?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If informed consent has been obtained for PGx research, record date of informed consent obtained
    Beschreibung

    If informed consent has been obtained for PGx research, record date of informed consent obtained

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    If informed consent has been obtained for PGx research, has blood been collected for PGx research?
    Beschreibung

    Has blood been collected for PGx research?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [2,1]
    C0005834
    UMLS CUI [2,2]
    C2347500
    If blood sample has been collected for PGx reserach, record date sample taken
    Beschreibung

    If blood sample has been collected for PGx reserach, record date sample taken

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    If informed consent has not been obtained for PGx research, check reason
    Beschreibung

    If informed consent has not been obtained for PGx research, check reason

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C2826287
    If other reason for informed consent not beeing obtained for PGx research, please specify
    Beschreibung

    If other reason for informed consent not beeing obtained for PGx research, please specify

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C2826287
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Sample Type
    Beschreibung

    Sample Type

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2347029
    Genetics Type
    Beschreibung

    Genetics Type

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0017399
    Investigational Product Compliance - Pazopanib
    Beschreibung

    Investigational Product Compliance - Pazopanib

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1321605
    UMLS CUI-3
    C1831796
    Pazopanib Dispensed Date
    Beschreibung

    Pazopanib Dispensed Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0947323
    UMLS CUI [1,3]
    C1831796
    Number of Tablets Dispensed
    Beschreibung

    Number of Tablets Dispensed

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0805077
    UMLS CUI [1,2]
    C0039225
    Investigational Product - First Dose
    Beschreibung

    Investigational Product - First Dose

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C3174092
    UMLS CUI-3
    C0205435
    Dose Start Date
    Beschreibung

    Dose Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0808070
    Biomarker Sample
    Beschreibung

    Biomarker Sample

    Alias
    UMLS CUI-1
    C0005516
    UMLS CUI-2
    C0370003
    Has biomarker sample been collected?
    Beschreibung

    Has biomarker sample been collected?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0005516
    If biomarker sample has been collected, record date sample taken
    Beschreibung

    If biomarker sample has been collected, record date sample taken

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0005516
    If biomarker sample has not been collected, provide reason
    Beschreibung

    If biomarker sample has not been collected, provide reason

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0005516
    UMLS CUI [1,3]
    C2826287
    If other reason for sample not been collected, please specify
    Beschreibung

    If other reason for sample not been collected, please specify

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C2826287
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Biomarker Sample Type
    Beschreibung

    Biomarker Sample Type

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2347029
    UMLS CUI [1,2]
    C0005516
    Biomarker sample Number
    Beschreibung

    Biomarker sample Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005516
    UMLS CUI [1,2]
    C1299222
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Day 1 Pre-Dose -Vital Signs; Pharmacogenetic Research Consent/ Blood Sample Collection; Investigational Product Compliance (Pazopanib); Investigational Product (First Dose); Biomarker Samples

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Date of visit/ assessment
    C1320303 (UMLS CUI-1)
    C2985720 (UMLS CUI-2)
    Date of visit/ assessment
    Item
    Date of visit/ assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Actual Date - Vital Signs
    Item
    Actual Date - Vital Signs
    date
    C2826644 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Sitting Systolic blood pressure 1st reading
    Item
    Sitting Systolic blood pressure 1st reading
    integer
    C1319893 (UMLS CUI [1])
    Sitting diastolic blood pressure 1st reading
    Item
    Sitting diastolic blood pressure 1st reading
    integer
    C1319894 (UMLS CUI [1])
    Sitting Systolic blood pressure 2nd reading
    Item
    Sitting Systolic blood pressure 2nd reading
    integer
    C1319893 (UMLS CUI [1])
    Sitting diastolic blood pressure 2nd reading
    Item
    Sitting diastolic blood pressure 2nd reading
    integer
    C1319894 (UMLS CUI [1])
    Sitting Systolic blood pressure 3rd reading
    Item
    Sitting Systolic blood pressure 3rd reading
    integer
    C1319893 (UMLS CUI [1])
    Sitting diastolic blood pressure 3rd reading
    Item
    Sitting diastolic blood pressure 3rd reading
    integer
    C1319894 (UMLS CUI [1])
    Sitting Mean Systolic Blood pressure
    Item
    Sitting Mean Systolic Blood pressure
    integer
    C1319893 (UMLS CUI [1,1])
    C0444504 (UMLS CUI [1,2])
    Sitting Mean Diastolic Blood pressure
    Item
    Sitting Mean Diastolic Blood pressure
    integer
    C1319894 (UMLS CUI [1,1])
    C0444504 (UMLS CUI [1,2])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Pharmacogenetic Research Consent/ Blood Sample Collection
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    C0005834 (UMLS CUI-3)
    Has informed consent been obtained for PGx research?
    Item
    Has informed consent been obtained for PGx research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    If informed consent has been obtained for PGx research, record date of informed consent obtained
    Item
    If informed consent has been obtained for PGx research, record date of informed consent obtained
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has blood been collected for PGx research?
    Item
    If informed consent has been obtained for PGx research, has blood been collected for PGx research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0005834 (UMLS CUI [2,1])
    C2347500 (UMLS CUI [2,2])
    If blood sample has been collected for PGx reserach, record date sample taken
    Item
    If blood sample has been collected for PGx reserach, record date sample taken
    date
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If informed consent has not been obtained for PGx research, check reason
    integer
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [1,3])
    If informed consent has not been obtained for PGx research, check reason
    Code List
    If informed consent has not been obtained for PGx research, check reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (3)
    If other reason for informed consent not beeing obtained for PGx research, please specify
    Item
    If other reason for informed consent not beeing obtained for PGx research, please specify
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Sample Type
    Item
    Sample Type
    text
    C2347029 (UMLS CUI [1])
    Genetics Type
    Item
    Genetics Type
    text
    C0017399 (UMLS CUI [1])
    Item Group
    Investigational Product Compliance - Pazopanib
    C0304229 (UMLS CUI-1)
    C1321605 (UMLS CUI-2)
    C1831796 (UMLS CUI-3)
    Pazopanib Dispensed Date
    Item
    Pazopanib Dispensed Date
    date
    C0011008 (UMLS CUI [1,1])
    C0947323 (UMLS CUI [1,2])
    C1831796 (UMLS CUI [1,3])
    Number of Tablets Dispensed
    Item
    Number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Item Group
    Investigational Product - First Dose
    C0304229 (UMLS CUI-1)
    C3174092 (UMLS CUI-2)
    C0205435 (UMLS CUI-3)
    Dose Start Date
    Item
    Dose Start Date
    date
    C3174092 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item Group
    Biomarker Sample
    C0005516 (UMLS CUI-1)
    C0370003 (UMLS CUI-2)
    Has biomarker sample been collected?
    Item
    Has biomarker sample been collected?
    boolean
    C0005834 (UMLS CUI [1,1])
    C0005516 (UMLS CUI [1,2])
    If biomarker sample has been collected, record date sample taken
    Item
    If biomarker sample has been collected, record date sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0005516 (UMLS CUI [1,2])
    Item
    If biomarker sample has not been collected, provide reason
    integer
    C0200345 (UMLS CUI [1,1])
    C0005516 (UMLS CUI [1,2])
    C2826287 (UMLS CUI [1,3])
    If sample has not been collected, provide reason
    Code List
    If biomarker sample has not been collected, provide reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by investigator (2)
    CL Item
    Other, specify (3)
    If other reason for sample not been collected, please specify
    Item
    If other reason for sample not been collected, please specify
    text
    C0200345 (UMLS CUI [1,1])
    C2826287 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Biomarker Sample Type
    Item
    Biomarker Sample Type
    text
    C2347029 (UMLS CUI [1,1])
    C0005516 (UMLS CUI [1,2])
    Biomarker sample Number
    Item
    Biomarker sample Number
    integer
    C0005516 (UMLS CUI [1,1])
    C1299222 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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