ID

29930

Descrição

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.

Palavras-chave

  1. 27/04/2018 27/04/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

27 de abril de 2018

DOI

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Licença

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

Pharmacogenetic Research

Consent for PGx-Pharmacogenetic Research
Descrição

Consent for PGx-Pharmacogenetic Research

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

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 de dados

text

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

Reason for no Consent for Pharmacogenetic Reasearch

Tipo de dados

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
Descrição

Other Reason for no Consent for Pharmacogenetic Reasearch

Tipo de dados

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)
Descrição

Blood sample collection (DNA)

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

Blood sample for pharmacogenetic research

Tipo de dados

text

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

Date blood sample taken for pharmacogenetic research

Tipo de dados

date

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

Withdrawal of consent for pharmacogenetic research

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Has subject withdrawn consent for PGx-Pharmacogenetic research?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

Withdrawal of consent for pharmacogenetic research

Tipo de dados

text

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

Blood Sample Destruction

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

Blood Sample Destruction Request

Tipo de dados

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?
Descrição

Reason for Blood Sample Destruction

Tipo de dados

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
Descrição

Other Reason for Blood Sample Destruction

Tipo de dados

text

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

Similar models

Pharmacogenetic Research

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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])
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])
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])
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])
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])
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])
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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