ID

30201

Descripción

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.

Palabras clave

Versiones (1)
  1. 18/5/18 18/5/18 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 de mayo de 2018

DOI

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Licencia

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

Inglés

Administrative Data and Pharmacokinetics and Laboratory - Visit 8

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject identifier
Descripción

Subject identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Visit Date

Tipo de datos

date

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

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).
Descripción

Date of last dose of Investigational Product

Tipo de datos

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).
Descripción

Time of last dose of Investigational Product

Tipo de datos

time

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

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

Tipo de datos

date

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

Planned Relative Time: 0 to 24 hours post-dose

Tipo de datos

time

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

Sample Identifier Label

Tipo de datos

text

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

Investigational Product Container Number

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

Investigational Product Container Number

Tipo de datos

text

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

Central Laboratory

Alias
UMLS CUI-1
C1880016
Date of Blood Collection
Descripción

Date of Blood Collection

Tipo de datos

date

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

Date of Urine Collection for Urinalysis

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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