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30210

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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 15, Week 52, Day 365+/-2 days.

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  1. 18.05.18 18.05.18 - Sarah Riepenhausen
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GlaxoSmithKline

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18. Mai 2018

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    Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123

    Englisch

    Administrative Data and Pharmacokinetics and Laboratory - Visit 15

    1 Formulare  
    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject identifier
    Beschreibung

    Subject identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date
    Beschreibung

    Visit Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Investigational Product, Pharmacokinetics
    Beschreibung

    Investigational Product, Pharmacokinetics

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

    Date of last dose of Investigational Product

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C1762893 (Date last dose)
    LOINC
    LP29043-4
    Record the time of the subjects last dose of investigational product (prior to pharmacokinetic sample).
    Beschreibung

    Time of last dose of Investigational Product

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0946444 (Time last dose)
    LOINC
    LP29120-0
    Date Pharmacokinetics blood sample taken
    Beschreibung

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

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Actual Time Pharmacokinetics blood sample taken
    Beschreibung

    Planned Relative Time: 30-60 minutes post-dose

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0201734 (Pharmacokinetic study)
    SNOMED
    48684007
    UMLS CUI [1,2]
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Attach sample identifier label here.
    Beschreibung

    Sample Identifier Label

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439568 (Post-dose)
    SNOMED
    255566006
    UMLS CUI [1,2]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,3]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Central Laboratory
    Beschreibung

    Central Laboratory

    Alias
    UMLS CUI-1
    C1880016 (Central Laboratory)
    Date of Blood Collection
    Beschreibung

    Date of Blood Collection

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Date of urine Collection for Urinalysis
    Beschreibung

    Date of Urine Collection for Urinalysis

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0200354 (Urine Specimen Collection)
    SNOMED
    57617002
    UMLS CUI [1,2]
    C1317250 (Collection Date)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Administrative Data and Pharmacokinetics and Laboratory - Visit 15

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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
    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])
    Zum Seitenanfang zurückkehren 

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