0 Ratings
ID

41258

Description

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Versions (1)
  1. 7/28/20 7/28/20 -
Copyright Holder

GlaxoSmithKline

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July 28, 2020

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Creative Commons BY 4.0
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    Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

    English

    PGx-Pharmacogenetic Research; Concomitant Medications

    1 forms  
    Administrative
    Description

    Administrative

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

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    PGx-Pharmacogenetic Research
    Description

    PGx-Pharmacogenetic Research

    Alias
    UMLS CUI-1
    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)
    Date informed consnet obtained for PGx-Pharmacogenetic research
    Description

    Date informed consnet obtained for PGx-Pharmacogenetic research

    Data type

    date

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

    If no informed consent has been obtained, check one reason

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347500 (Pharmacogenetic Test)
    UMLS CUI [1,2]
    C0021430 (Informed Consent)
    UMLS CUI [1,3]
    C1882120 (Not Obtained)
    UMLS CUI [1,4]
    C0566251 (Reason and justification)
    SNOMED
    288830005
    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
    Description

    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?

    Data type

    boolean

    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
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    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))
    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 a request has been made for sample destruction, check one reason
    Description

    If a request has been made for sample destruction, 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
    If other reason for request for sample destruction, specify
    Description

    If other reason for request for sample destruction, specify

    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
    UMLS CUI [2,1]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [2,2]
    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

    Were any concomitant medications taken by the subject during the study?

    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
    Unit Dose
    Description

    Unit Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C0869039 (Unit dose)
    SNOMED
    408102007
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795 (Unit of Measure)
    SNOMED
    767524001
    Frequency
    Description

    Frequency

    Data type

    text

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

    Route

    Data type

    text

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

    Reason for Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    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]
    C2826734 (Concomitant Medication Start Date)
    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 [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    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

    PGx-Pharmacogenetic Research; Concomitant Medications

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    PGx-Pharmacogenetic Research
    C2347500 (UMLS CUI-1)
    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])
    Date informed consnet obtained for PGx-Pharmacogenetic research
    Item
    Date informed consnet obtained for PGx-Pharmacogenetic research
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If no informed consent has been obtained, check one reason
    text
    C2347500 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C1882120 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    If no informed consent has been obtained, check one reason
    Code List
    If no informed consent has been obtained, check one reason
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by Investigator (2)
    CL Item
    Other, specify (Z)
    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
    Item
    Has a blood sample (DNA) been collected for PGx-pharmacogenetic research?
    boolean
    C2347500 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    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])
    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 a request has been made for sample destruction, 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 a request has been made for sample destruction, check one reason
    Code List
    If a request has been made for sample destruction, check one reason
    CL Item
    Subject requested (1)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (Z)
    If other reason for request for sample destruction, specify
    Item
    If other reason for request for sample destruction, specify
    text
    C1948029 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1272683 (UMLS CUI [1,3])
    C0392360 (UMLS CUI [1,4])
    C0205394 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    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])
    Unit Dose
    Item
    Unit Dose
    float
    C0869039 (UMLS CUI [1])
    Item
    Units
    text
    C1519795 (UMLS CUI [1])
    Units
    Code List
    Units
    CL Item
    Tablet (TAB)
    CL Item
    Microlitre (MCL)
    CL Item
    Millilitre (ML)
    CL Item
    Litre (L)
    CL Item
    Microgram (MCG)
    CL Item
    Milligram (MG)
    CL Item
    Gram (G)
    Item
    Frequency
    text
    C3476109 (UMLS CUI [1])
    Frequency
    Code List
    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)
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Route
    Code List
    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)
    Reason for Medication
    Item
    Reason for Medication
    text
    C0392360 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Medication Start Date
    Item
    Medication Start Date
    date
    C2826734 (UMLS CUI [1])
    Medication Start Time
    Item
    Medication Start Time
    time
    C2826734 (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
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    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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