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ID

42305

Description

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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Versions (1)
  1. 5/26/21 5/26/21 -
Copyright Holder

GlaxoSmithKline

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May 26, 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

    English

    Concomitant Medications

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    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 Medications
    Description

    Concomitant Medications

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Description

    (Trade Name preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Unit Dose
    Description

    Unit Dose

    Data type

    float

    Alias
    UMLS CUI [1]
    C0869039
    Units
    Description

    Units

    Data type

    text

    Alias
    UMLS CUI [1]
    C1519795
    Medication Frequency
    Description

    Medication Frequency

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Medication Route
    Description

    Medication Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Reason for Medication
    Description

    Reason for Medication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0013227
    Medication Start Date
    Description

    Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826734
    Medication Start Time
    Description

    Medication Start Time

    Data type

    time

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

    Medication Taken Prior to Study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826667
    Medication Stop Date
    Description

    Medication Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826744
    Medication Stop Time
    Description

    Medication Stop Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826659
    Ongoing Medication?
    Description

    Ongoing Medication?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
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    Similar models

    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
    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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