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42305

Beskrivning

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

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Versioner (1)
  1. 2021-05-26 2021-05-26 -
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GlaxoSmithKline

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26 maj 2021

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Creative Commons BY 4.0
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    Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812

    Engelsk

    Concomitant Medications

    1 Formulär  
    Administrative
    Beskrivning

    Administrative

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

    Subject Identifier

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Medications
    Beskrivning

    Concomitant Medications

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

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

    Datatyp

    boolean

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

    Concomitant Medications

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

    (Trade Name preferred)

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Unit Dose
    Beskrivning

    Unit Dose

    Datatyp

    float

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

    Units

    Datatyp

    text

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

    Medication Frequency

    Datatyp

    text

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

    Medication Route

    Datatyp

    text

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

    Reason for Medication

    Datatyp

    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
    Beskrivning

    Medication Start Date

    Datatyp

    date

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

    Medication Start Time

    Datatyp

    time

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

    Medication Taken Prior to Study?

    Datatyp

    boolean

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

    Medication Stop Date

    Datatyp

    date

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

    Medication Stop Time

    Datatyp

    time

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

    Ongoing Medication?

    Datatyp

    boolean

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

    Concomitant Medications

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    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
    C2360065 (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
    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)
    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 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
    C1301880 (UMLS CUI [1,1])
    C2347852 (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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