ID

39349

Beskrivning

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

Nyckelord

Versioner (1)
  1. 2019-12-27 2019-12-27 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

27 december 2019

DOI

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Creative Commons BY-NC 3.0
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GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586

Engelsk

PGx

1 Formulär  
  1. StudyEvent: ODM
    1. PGx
PGx-Pharmacogenetic Research Consent
Beskrivning

PGx-Pharmacogenetic Research Consent

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

Pharmacogenetic Test, Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
Yes, Date informed consent obtained for PGx-Pharmacogenetic research
Beskrivning

Pharmacogenetic Test, Informed Consent, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
Yes, Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research
Beskrivning

Pharmacogenetic Test, Collection of blood specimen for laboratory procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
Yes, record date sample taken
Beskrivning

Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0011008
No, check reason
Beskrivning

Pharmacogenetic Test, Informed Consent, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Specify
Beskrivning

Pharmacogenetic Test, Informed Consent, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0566251
Pharmacogenetic (PGx) Research Withdrawal of Consent
Beskrivning

Pharmacogenetic (PGx) Research Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
Has subject withdrawn consent for PGx research?
Beskrivning

Pharmacogenetic Test, Informed Consent, Withdraw (activity)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
Yes, date informed consent withdrawn
Beskrivning

Pharmacogenetic Test, Informed Consent, Withdraw (activity), Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
UMLS CUI [1,4]
C0011008
Has a request been made for sample destruction?
Beskrivning

Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
Yes, check reason
Beskrivning

Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
Other, specify
Beskrivning

Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification

Datatyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0566251
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Similar models

PGx

1 Formulär
  1. StudyEvent: ODM
    1. PGx
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
PGx-Pharmacogenetic Research Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Pharmacogenetic Test, Informed Consent
Item
Has informed consent been obtained for PGx-Pharmacogenetic research
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Pharmacogenetic Test, Informed Consent, Date in time
Item
Yes, Date informed consent obtained for PGx-Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure
Item
Yes, Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacogenetic Test, Collection of blood specimen for laboratory procedure, Date in time
Item
Yes, record date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
No, check reason
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Reason and justification
Code List
No, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Pharmacogenetic Test, Informed Consent, Reason and justification
Item
Specify
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Pharmacogenetic (PGx) Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
Pharmacogenetic Test, Informed Consent, Withdraw (activity)
Item
Has subject withdrawn consent for PGx research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Withdraw (activity), Date in time
Item
Yes, date informed consent withdrawn
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action
Item
Has a request been made for sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
Item
Yes, check reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification
Code List
Yes, check reason
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Item
Other, specify
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0566251 (UMLS CUI [1,5])
Pharmacogenetic Test, Blood specimen, Destruction (action), Request - action, Reason and justification
Code List
Other, specify
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