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ID

30201

Description

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Administrative Data and Pharmacokinetics and Laboratory; Visit 8, Week 24, Day 169+/-2 days.

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Versions (1)
  1. 5/18/18 5/18/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

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May 18, 2018

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Creative Commons BY-NC 3.0
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    Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

    English

    Administrative Data and Pharmacokinetics and Laboratory - Visit 8

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Description

    Subject identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Investigational Product, Pharmacokinetics
    Description

    Investigational Product, Pharmacokinetics

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0031327
    Record the date of the subjects last dose of investigational product (prior to Pharmacokinetic sample).
    Description

    Date of last dose of Investigational Product

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1762893
    Record the time of the subjects last dose of investigational product (prior to pharmacokinetic sample).
    Description

    Time of last dose of Investigational Product

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0946444
    Date Pharmacokinetics blood sample taken
    Description

    If sample is missed or lost, write "NA" in the Date Sample Taken column.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0201734
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C1302413
    Actual Time Pharmacokinetics blood sample taken
    Description

    Planned Relative Time: 0 to 24 hours post-dose

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0201734
    UMLS CUI [1,2]
    C1277698
    UMLS CUI [1,3]
    C0040223
    Attach sample identifier label here.
    Description

    Sample Identifier Label

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0600091
    Investigational Product Container Number
    Description

    Investigational Product Container Number

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0180098
    UMLS CUI-3
    C0600091
    Investigational Product Container Number
    Description

    Investigational Product Container Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0180098
    UMLS CUI [1,3]
    C0600091
    Central Laboratory
    Description

    Central Laboratory

    Alias
    UMLS CUI-1
    C1880016
    Date of Blood Collection
    Description

    Date of Blood Collection

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Date of urine Collection for Urinalysis
    Description

    Date of Urine Collection for Urinalysis

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C1317250
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    Similar models

    Administrative Data and Pharmacokinetics and Laboratory - Visit 8

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Investigational Product, Pharmacokinetics
    C0304229 (UMLS CUI-1)
    C0031327 (UMLS CUI-2)
    Date of last dose of Investigational Product
    Item
    Record the date of the subjects last dose of investigational product (prior to Pharmacokinetic sample).
    date
    C0304229 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    Time of last dose of Investigational Product
    Item
    Record the time of the subjects last dose of investigational product (prior to pharmacokinetic sample).
    time
    C0304229 (UMLS CUI [1,1])
    C0946444 (UMLS CUI [1,2])
    Date Pharmacokinetics blood sample taken
    Item
    Date Pharmacokinetics blood sample taken
    date
    C0201734 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Actual Time Pharmacokinetics blood sample taken
    Item
    Actual Time Pharmacokinetics blood sample taken
    time
    C0201734 (UMLS CUI [1,1])
    C1277698 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Sample Identifier Label
    Item
    Attach sample identifier label here.
    text
    C0439568 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Item Group
    Investigational Product Container Number
    C0304229 (UMLS CUI-1)
    C0180098 (UMLS CUI-2)
    C0600091 (UMLS CUI-3)
    Investigational Product Container Number
    Item
    Investigational Product Container Number
    text
    C0304229 (UMLS CUI [1,1])
    C0180098 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Item Group
    Central Laboratory
    C1880016 (UMLS CUI-1)
    Date of Blood Collection
    Item
    Date of Blood Collection
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Date of Urine Collection for Urinalysis
    Item
    Date of urine Collection for Urinalysis
    date
    C0200354 (UMLS CUI [1,1])
    C1317250 (UMLS CUI [1,2])
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