ID

29930

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 27-04-18 27-04-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

27 april 2018

DOI

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Licentie

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

Engels

Pharmacogenetic Research

1 Formulieren  
Consent for PGx-Pharmacogenetic Research
Beschrijving

Consent for PGx-Pharmacogenetic Research

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

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.

Datatype

text

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

Reason for no Consent for Pharmacogenetic Reasearch

Datatype

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
Beschrijving

Other Reason for no Consent for Pharmacogenetic Reasearch

Datatype

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)
Beschrijving

Blood sample collection (DNA)

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

Blood sample for pharmacogenetic research

Datatype

text

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

Date blood sample taken for pharmacogenetic research

Datatype

date

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

Withdrawal of consent for pharmacogenetic research

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Has subject withdrawn consent for PGx-Pharmacogenetic research?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

Withdrawal of consent for pharmacogenetic research

Datatype

text

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

Blood Sample Destruction

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

Blood Sample Destruction Request

Datatype

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?
Beschrijving

Reason for Blood Sample Destruction

Datatype

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
Beschrijving

Other Reason for Blood Sample Destruction

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

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