ID

30201

Beskrivning

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.

Nyckelord

Versioner (1)
  1. 2018-05-18 2018-05-18 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 maj 2018

DOI

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Licens

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

Engelsk

Administrative Data and Pharmacokinetics and Laboratory - Visit 8

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identifier
Beskrivning

Subject identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

Visit Date

Datatyp

date

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

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).
Beskrivning

Date of last dose of Investigational Product

Datatyp

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).
Beskrivning

Time of last dose of Investigational Product

Datatyp

time

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

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

Datatyp

date

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

Planned Relative Time: 0 to 24 hours post-dose

Datatyp

time

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

Sample Identifier Label

Datatyp

text

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

Investigational Product Container Number

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

Investigational Product Container Number

Datatyp

text

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

Central Laboratory

Alias
UMLS CUI-1
C1880016
Date of Blood Collection
Beskrivning

Date of Blood Collection

Datatyp

date

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

Date of Urine Collection for Urinalysis

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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