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ID

41757

Beschreibung

Study ID: 103096 Clinical Study ID: 103096 Study Title: A randomised, double blind, placebo controlled, incomplete block, five-way cross-over study to investigate the effect of one week repeat dosing of GW685698X and FP on twenty-four hour serum cortisol in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Fluticasone Furoate;Fluticasone Propionate Trade Name: Fluticasone Furoate;Fluticasone Propionate Study Indication: Asthma

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  1. 13/01/21 13/01/21 -
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GlaxoSmithKline

Hochgeladen am

13 gennaio 2021

DOI

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Creative Commons BY 4.0
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    Effect of one week repeat dosing of GW685698X and FP on serum cortisol (103096)

    Englisch

    Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Volunteer Identifier
    Beschreibung

    Volunteer Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1300638
    UMLS CUI [1,2]
    C0020155
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Beschreibung

    Centre Number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Status of Treatment Blind
    Beschreibung

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659
    UMLS CUI-2
    C2347038
    Was the treatment blind broken during the study?
    Beschreibung

    Was the treatment blind broken during the study?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3897431
    Date blind broken
    Beschreibung

    Date blind broken

    Datentyp

    date

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

    Check one Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    Specify other reason blind broken
    Beschreibung

    Specify other reason blind broken

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3897431
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research
    Beschreibung

    Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research

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

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    Beschreibung

    If yes, record the date informed consent obtained for PGx-Pharmacogenetic research

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C0011008
    If no informed consent obtained, check one reason
    Beschreibung

    If no informed consent obtained, check one reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C1882120
    Specify other reason for informed consent not been obtained
    Beschreibung

    Specify other reason for informed consent not been obtained

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C1882120
    UMLS CUI [2,1]
    C0392360
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Pharmacogenetic Research - Blood Sample Collection (DNA)
    Beschreibung

    Pharmacogenetic Research - Blood Sample Collection (DNA)

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C2347500
    Has a blood sample been collected for pGx-pharmacogenetic research?
    Beschreibung

    Has a blood sample been collected for pGx-pharmacogenetic research?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C2347500
    If yes, record the date sample taken
    Beschreibung

    If yes, record the date sample taken

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    Pharmacogenetic Research - Withdrawal of consent
    Beschreibung

    Pharmacogenetic Research - Withdrawal of consent

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C0021430
    UMLS CUI-3
    C2349954
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Beschreibung

    Has subject withdrawn consent for PGx-Pharmacogenetic research?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C2349954
    Pharmacogenetic Research - Blood Sample Destruction
    Beschreibung

    Pharmacogenetic Research - Blood Sample Destruction

    Alias
    UMLS CUI-1
    C2347500
    UMLS CUI-2
    C1948029
    UMLS CUI-3
    C0178913
    Has a request been made for sample destruction?
    Beschreibung

    Has a request been made for sample destruction?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    If request for blood sample destruction has been made, check one reason
    Beschreibung

    If request for blood sample destruction has been made, check one reason

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [1,4]
    C0392360
    Specify other reason for request for blood sample destruction.
    Beschreibung

    Specify other reason for request for blood sample destruction.

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1948029
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1272683
    UMLS CUI [2,1]
    C0392360
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [3]
    C2348235
    Concomitant Medications
    Beschreibung

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Were any concomitant medications taken by the subject during the study?
    Beschreibung

    If yes, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Concomitant Medications
    Beschreibung

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Beschreibung

    Trade Name preferred

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013227
    Medication Unit Dose
    Beschreibung

    Medication Unit Dose

    Datentyp

    float

    Alias
    UMLS CUI [1]
    C2826646
    Medication Units
    Beschreibung

    Medication Units

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C1519795
    Medication Frequency
    Beschreibung

    Medication Frequency

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3476109
    Medication Route
    Beschreibung

    Medication Route

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0013153
    Reason for Medications
    Beschreibung

    Reason for Medications

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C2347852
    Medication Start Date
    Beschreibung

    Medication Start Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826734
    Medication Start Time
    Beschreibung

    Medication Start Time

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C1301880
    Medication Taken Prior to Study?
    Beschreibung

    Medication Taken Prior to Study?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Medication Stop Date
    Beschreibung

    Medication Stop Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826744
    Medication Stop Time
    Beschreibung

    Medication Stop Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C2826659
    Ongoing Medication?
    Beschreibung

    Ongoing Medication?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2826666
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    Ähnliche Modelle

    Running Logs and End of Study - Status of Treatment Blind; Pharmacogenetic Research; Concomitant Medications

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Volunteer Identifier
    Item
    Volunteer Identifier
    text
    C1300638 (UMLS CUI [1,1])
    C0020155 (UMLS CUI [1,2])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Status of Treatment Blind
    C0749659 (UMLS CUI-1)
    C2347038 (UMLS CUI-2)
    Was the treatment blind broken during the study?
    Item
    Was the treatment blind broken during the study?
    boolean
    C3897431 (UMLS CUI [1])
    Date blind broken
    Item
    Date blind broken
    date
    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)
    Specify other reason blind broken
    Item
    Specify other reason blind broken
    text
    C3897431 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item Group
    Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Item
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    If yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    Item
    If yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    date
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If no informed consent obtained, check one reason
    text
    C0392360 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C1882120 (UMLS CUI [1,3])
    If no informed consent obtained, check one reason
    Code List
    If no informed consent obtained, check one reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    Specify other reason for informed consent not been obtained
    Item
    Specify other reason for informed consent not been obtained
    text
    C0021430 (UMLS CUI [1,1])
    C1882120 (UMLS CUI [1,2])
    C0392360 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item Group
    Pharmacogenetic Research - Blood Sample Collection (DNA)
    C0005834 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Has a blood sample been collected for pGx-pharmacogenetic research?
    Item
    Has a blood sample been collected for pGx-pharmacogenetic research?
    boolean
    C0005834 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    If yes, record the date sample taken
    Item
    If yes, record the date sample taken
    date
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item Group
    Pharmacogenetic Research - Withdrawal of consent
    C2347500 (UMLS CUI-1)
    C0021430 (UMLS CUI-2)
    C2349954 (UMLS CUI-3)
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Item
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C2349954 (UMLS CUI [1,3])
    Item Group
    Pharmacogenetic Research - Blood Sample Destruction
    C2347500 (UMLS CUI-1)
    C1948029 (UMLS CUI-2)
    C0178913 (UMLS CUI-3)
    Has a request been made for sample destruction?
    Item
    Has a request been made for sample destruction?
    boolean
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    Item
    If request for blood sample destruction has been made, check one reason
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    If request for blood sample destruction has been made, check one reason
    Code List
    If request for blood sample destruction has been made, check one reason
    CL Item
    Subject requested (1)
    CL Item
    Other, specify (Z)
    Specify other reason for request for blood sample destruction.
    Item
    Specify other reason for request for blood sample destruction.
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [3])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Were any concomitant medications taken by the subject during the study?
    Item
    Were any concomitant medications taken by the subject during the study?
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    Concomitant Medications
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C0013227 (UMLS CUI [1])
    Medication Unit Dose
    Item
    Medication Unit Dose
    float
    C2826646 (UMLS CUI [1])
    Item
    Medication Units
    text
    C0013227 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Units
    Code List
    Medication Units
    CL Item
    Tablet (TAB)
    CL Item
    Microlitre (MCL)
    CL Item
    Mililitre (ML)
    CL Item
    Litre (L)
    CL Item
    Microgram (MCG)
    CL Item
    Miligram (MG)
    CL Item
    Gram (G)
    Item
    Medication Frequency
    text
    C3476109 (UMLS CUI [1])
    Medication Frequency
    Code List
    Medication Frequency
    CL Item
    1 x Daily (OD/QD)
    CL Item
    2 x Daily (BID)
    CL Item
    3 x Daily (TID)
    CL Item
    4 x Daily (QID)
    CL Item
    As required (PRN)
    CL Item
    Single dose (ONCE)
    Item
    Medication Route
    text
    C0013153 (UMLS CUI [1])
    Medication Route
    Code List
    Medication Route
    CL Item
    Intramuscular (IM)
    CL Item
    Inhalation (IH)
    CL Item
    Intravenous (IV)
    CL Item
    Nasal (NS)
    CL Item
    Topical (TP)
    CL Item
    Oral (PO)
    CL Item
    Vaginal (VG)
    Reason for Medications
    Item
    Reason for Medications
    text
    C3146298 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Medication Start Date
    Item
    Medication Start Date
    date
    C2826734 (UMLS CUI [1])
    Medication Start Time
    Item
    Medication Start Time
    time
    C2347852 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Medication Taken Prior to Study?
    Item
    Medication Taken Prior to Study?
    boolean
    C2826667 (UMLS CUI [1])
    Medication Stop Date
    Item
    Medication Stop Date
    date
    C2826744 (UMLS CUI [1])
    Medication Stop Time
    Item
    Medication Stop Time
    time
    C2826659 (UMLS CUI [1])
    Ongoing Medication?
    Item
    Ongoing Medication?
    boolean
    C2826666 (UMLS CUI [1])
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