ID

19113

Beschrijving

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains the Pharmacogenetic and Pharmacogenomic Research.

Trefwoorden

Versies (2)
  1. 04-10-16 04-10-16 -
  2. 05-12-16 05-12-16 -
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5 december 2016

DOI

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Licentie

Creative Commons BY-NC 3.0
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M.Alzheimer GSK - Pharmacogenetic and Pharmacogenomic Research NCT00334568/ GSK-AVA100193

Engels

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Pharmacogenetic and Pharmacogenomic Research

1 Formulieren  
General Information
Beschrijving

General Information

Alias
UMLS CUI-1
C1508263
Protocol Identifier: AVA100193
Beschrijving

Study Identifier

Datatype

boolean

Alias
UMLS CUI [1]
C2826693
Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic Research
Beschrijving

PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic Research

Alias
UMLS CUI-1
C0013216
Has informed consent been obtained for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic Research?
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
If yes, record the date informed consent obtained for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic research
Beschrijving

Date informed consent

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0021430
If no, select one reason
Beschrijving

Reason for not obtaining informed consent

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0566251
If Other, please specify
Beschrijving

Reason Informed Consent Obtained Specification

Datatype

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C2348235
Blood sample collection (DNA)
Beschrijving

Blood sample collection (DNA)

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

Has a blood sample been collected for PGx-pharmacogenetic research?

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
If yes, record the date samples taken.
Beschrijving

Date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Withdrawal of consent
Beschrijving

Withdrawal of consent

Alias
UMLS CUI-1
C1707492
Has subject withdrawn consent for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic research?
Beschrijving

Has subject withdrawn consent for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic research?

Datatype

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0013216
Blood sample Destruction
Beschrijving

Blood sample Destruction

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

Request for sample destruction

Datatype

boolean

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
If yes, specify reason
Beschrijving

Request for sample destruction reason

Datatype

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
UMLS CUI [1,4]
C0392360
If other, please specify
Beschrijving

Request for sample destruction other

Datatype

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
UMLS CUI [1,4]
C2348235
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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Pharmacogenetic and Pharmacogenomic Research

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Study Identifier
Item
Protocol Identifier: AVA100193
boolean
C2826693 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic Research
C0013216 (UMLS CUI-1)
Informed Consent
Item
Has informed consent been obtained for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic Research?
boolean
C0021430 (UMLS CUI [1])
Date informed consent
Item
If yes, record the date informed consent obtained for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic research
date
C0011008 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Item
If no, select one reason
text
C0021430 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for not obtaining informed consent
Code List
If no, select one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator  (2)
CL Item
Other (specify) (3)
Reason Informed Consent Obtained Specification
Item
If Other, please specify
text
C0021430 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Blood sample collection (DNA)
C0005834 (UMLS CUI-1)
Has a blood sample been collected for PGx-pharmacogenetic research?
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
If yes, record the date samples taken.
date
C1302413 (UMLS CUI [1])
Item Group
Withdrawal of consent
C1707492 (UMLS CUI-1)
Has subject withdrawn consent for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic/PGm-Transcriptomic/PGm-Proteomic research?
boolean
C1707492 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
Item Group
Blood sample Destruction
C1948029 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
Request for sample destruction
Item
Has a request been made for sample destruction?
boolean
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Item
If yes, specify reason
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
If yes, specify reason
Code List
If yes, specify reason
CL Item
Subject requested (1)
CL Item
Other (specify) (2)
Request for sample destruction other
Item
If other, please specify
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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