ID

29930

Beschreibung

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.

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Versionen (1)
  1. 27.04.18 27.04.18 - Sarah Riepenhausen
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GlaxoSmithKline

Hochgeladen am

27. April 2018

DOI

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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

Englisch

Pharmacogenetic Research

1 Formulare  
Consent for PGx-Pharmacogenetic Research
Beschreibung

Consent for PGx-Pharmacogenetic Research

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

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.

Datentyp

text

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

Reason for no Consent for Pharmacogenetic Reasearch

Datentyp

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
Beschreibung

Other Reason for no Consent for Pharmacogenetic Reasearch

Datentyp

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)
Beschreibung

Blood sample collection (DNA)

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

Blood sample for pharmacogenetic research

Datentyp

text

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

Date blood sample taken for pharmacogenetic research

Datentyp

date

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

Withdrawal of consent for pharmacogenetic research

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Has subject withdrawn consent for PGx-Pharmacogenetic research?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

Withdrawal of consent for pharmacogenetic research

Datentyp

text

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

Blood Sample Destruction

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

Blood Sample Destruction Request

Datentyp

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?
Beschreibung

Reason for Blood Sample Destruction

Datentyp

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
Beschreibung

Other Reason for Blood Sample Destruction

Datentyp

text

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

Pharmacogenetic Research

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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