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ID

41757

Description

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

Keywords

Versions (1)
  1. 1/13/21 1/13/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 13, 2021

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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)

    English

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

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Volunteer Identifier
    Description

    Volunteer Identifier

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1300638 (Identification number)
    SNOMED
    396278008
    UMLS CUI [1,2]
    C0020155 (Human Volunteers)
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Centre Number
    Description

    Centre Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Status of Treatment Blind
    Description

    Status of Treatment Blind

    Alias
    UMLS CUI-1
    C0749659 (Treatment Status)
    UMLS CUI-2
    C2347038 (Blinded Clinical Study)
    Was the treatment blind broken during the study?
    Description

    Was the treatment blind broken during the study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3897431 (Subject Unblinding Event Record)
    Date blind broken
    Description

    Date blind broken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Reason blind broken
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Specify other reason blind broken
    Description

    Specify other reason blind broken

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3897431 (Subject Unblinding Event Record)
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,3]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,4]
    C2348235 (Specification)
    Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research
    Description

    Pharmacogenetic Research - Consent for PGx-Pharmacogenetic Research

    Alias
    UMLS CUI-1
    C0021430 (Informed Consent)
    UMLS CUI-2
    C2347500 (Pharmacogenetic Test)
    Has informed consent been obtained for PGx-Pharmacogenetic research?
    Description

    Has informed consent been obtained for PGx-Pharmacogenetic research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    If yes, record the date informed consent obtained for PGx-Pharmacogenetic research
    Description

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

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    If no informed consent obtained, check one reason
    Description

    If no informed consent obtained, check one reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C1882120 (Not Obtained)
    Specify other reason for informed consent not been obtained
    Description

    Specify other reason for informed consent not been obtained

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0021430 (Informed Consent)
    UMLS CUI [1,2]
    C1882120 (Not Obtained)
    UMLS CUI [2,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [2,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [2,3]
    C2348235 (Specification)
    Pharmacogenetic Research - Blood Sample Collection (DNA)
    Description

    Pharmacogenetic Research - Blood Sample Collection (DNA)

    Alias
    UMLS CUI-1
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI-2
    C2347500 (Pharmacogenetic Test)
    Has a blood sample been collected for pGx-pharmacogenetic research?
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C2347500 (Pharmacogenetic Test)
    If yes, record the date sample taken
    Description

    If yes, record the date sample taken

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Pharmacogenetic Research - Withdrawal of consent
    Description

    Pharmacogenetic Research - Withdrawal of consent

    Alias
    UMLS CUI-1
    C2347500 (Pharmacogenetic Test)
    UMLS CUI-2
    C0021430 (Informed Consent)
    UMLS CUI-3
    C2349954 (Withdraw (activity))
    Has subject withdrawn consent for PGx-Pharmacogenetic research?
    Description

    Has subject withdrawn consent for PGx-Pharmacogenetic research?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C2349954 (Withdraw (activity))
    Pharmacogenetic Research - Blood Sample Destruction
    Description

    Pharmacogenetic Research - Blood Sample Destruction

    Alias
    UMLS CUI-1
    C2347500 (Pharmacogenetic Test)
    UMLS CUI-2
    C1948029 (Destruction (action))
    UMLS CUI-3
    C0178913 (Blood specimen)
    SNOMED
    119297000
    Has a request been made for sample destruction?
    Description

    Has a request been made for sample destruction?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1948029 (Destruction (action))
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    If request for blood sample destruction has been made, check one reason
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029 (Destruction (action))
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [1,4]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    Specify other reason for request for blood sample destruction.
    Description

    Specify other reason for request for blood sample destruction.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1948029 (Destruction (action))
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C1272683 (Request - action)
    SNOMED
    385644000
    UMLS CUI [2,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [2,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [3]
    C2348235 (Specification)
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Were any concomitant medications taken by the subject during the study?
    Description

    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.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Drug Name
    Description

    Trade Name preferred

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Medication Unit Dose
    Description

    Medication Unit Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C2826646 (Concomitant Medication Dose Unit)
    Medication Units
    Description

    Medication Units

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Medication Frequency
    Description

    Medication Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109 (Medication frequency)
    LOINC
    LP149758-7
    Medication Route
    Description

    Medication Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Reason for Medications
    Description

    Reason for Medications

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Medication Start Date
    Description

    Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734 (Concomitant Medication Start Date)
    Medication Start Time
    Description

    Medication Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Medication Taken Prior to Study?
    Description

    Medication Taken Prior to Study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667 (Concomitant Medication Previous Occurrence)
    Medication Stop Date
    Description

    Medication Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744 (Concomitant Medication End Date)
    Medication Stop Time
    Description

    Medication Stop Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826659 (Concomitant Medication End Time)
    Ongoing Medication?
    Description

    Ongoing Medication?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
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    Similar models

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

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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