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ID

30210

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

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Versions (1)
  1. 18/05/2018 18/05/2018 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

18 mai 2018

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Administrative Data and Pharmacokinetics and Laboratory - Visit 15

    1 Formulaires  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject identifier
    Description

    Subject identifier

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Type de données

    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

    Type de données

    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

    Type de données

    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.

    Type de données

    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: 30-60 minutes post-dose

    Type de données

    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

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0439568
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0600091
    Central Laboratory
    Description

    Central Laboratory

    Alias
    UMLS CUI-1
    C1880016
    Date of Blood Collection
    Description

    Date of Blood Collection

    Type de données

    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

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C1317250
    Retour au début de la page

    Similar models

    Administrative Data and Pharmacokinetics and Laboratory - Visit 15

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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