ID

29930

Descrizione

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 Pharmacogenetic Research.

Keywords

versioni (1)
  1. 27.04.18 27.04.18 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

27. April 2018

DOI

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Licenza

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

Inglese

Pharmacogenetic Research

1 moduli  
Consent for PGx-Pharmacogenetic Research
Descrizione

Consent for PGx-Pharmacogenetic Research

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx-Pharmacogenetic research?
Descrizione

Should be completed at any time between Visits 2 and 16. If the question is answered No, pick one reason and do not complete the remainder of the page.

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If consent was not given, why?
Descrizione

Reason for no Consent for Pharmacogenetic Reasearch

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
If no consent was obtained for another reason, specify
Descrizione

Other Reason for no Consent for Pharmacogenetic Reasearch

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
UMLS CUI [1,4]
C0205394
Blood sample collection (DNA)
Descrizione

Blood sample collection (DNA)

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031325
Has a blood sample been collected for PGx-pharmacogenetic research?
Descrizione

Blood sample for pharmacogenetic research

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031325
If a blood sample was collected, record the date sample taken:
Descrizione

Date blood sample taken for pharmacogenetic research

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0031325
Withdrawal of consent for pharmacogenetic research
Descrizione

Withdrawal of consent for pharmacogenetic research

Alias
UMLS CUI-1
C1707492
UMLS CUI-2
C0031325
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Descrizione

Withdrawal of consent for pharmacogenetic research

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0031325
Blood Sample Destruction
Descrizione

Blood Sample Destruction

Alias
UMLS CUI-1
C1948029
UMLS CUI-2
C0178913
UMLS CUI-3
C0031325
Has a request been made for sample destruction?
Descrizione

Blood Sample Destruction Request

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If a request has been made for sample destruction, why?
Descrizione

Reason for Blood Sample Destruction

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C0392360
If there was another reason for the request for sample destruction, specify
Descrizione

Other Reason for Blood Sample Destruction

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C3840932
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Similar models

Pharmacogenetic Research

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Consent for PGx-Pharmacogenetic Research
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Item
Has informed consent been obtained for PGx-Pharmacogenetic research?
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Informed consent for Pharmacogenetic Research
Code List
Has informed consent been obtained for PGx-Pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Item
If consent was not given, why?
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for no Consent for Pharmacogenetic Reasearch
Code List
If consent was not given, why?
CL Item
Subject delined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other (Z)
Item
If no consent was obtained for another reason, specify
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Reason for no Consent for Pharmacogenetic Reasearch
Code List
If no consent was obtained for another reason, specify
Item Group
Blood sample collection (DNA)
C0005834 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
text
C0005834 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Informed consent for Pharmacogenetic Research
Code List
Has a blood sample been collected for PGx-pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Date blood sample taken for pharmacogenetic research
Item
If a blood sample was collected, record the date sample taken:
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0031325 (UMLS CUI [1,3])
Item Group
Withdrawal of consent for pharmacogenetic research
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-2)
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
text
C1707492 (UMLS CUI [1,1])
C0031325 (UMLS CUI [1,2])
Informed consent for Pharmacogenetic Research
Code List
Has subject withdrawn consent for PGx-Pharmacogenetic research?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Blood Sample Destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C0031325 (UMLS CUI-3)
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Informed consent for Pharmacogenetic Research
Code List
Has a request been made for sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If a request has been made for sample destruction, why?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for Blood Sample Destruction
Code List
If a request has been made for sample destruction, why?
CL Item
Subject requested (1)
CL Item
Other (Z)
Other Reason for Blood Sample Destruction
Item
If there was another reason for the request for sample destruction, specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
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