ID

33666

Description

Study ID: 106181 Clinical Study ID: B2C106181 Study Title: An open-label, single-arm study to determine the excretion balance and metabolic disposition of [14C]GW642444 administered as a single dose of an oral solution to healthy male volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01286831 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: vilanterol Trade Name: Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (2)
  1. 12/18/18 12/18/18 -
  2. 12/18/18 12/18/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 18, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Extension balance and metabolic disposition of vilanterol as a single oral dose. 106181

English

Pharmacogenetic (PGx) Research

1 forms  
Consent for PGx Research
Description

Consent for PGx Research

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
Has consent been obtained for PGx Research?
Description

Pharmacogenetic Test, Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
If YES, record the date informed consent obtained for PGx Research
Description

Pharmacogenetic Test, Informed Consent, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0011008
If NO, choose ONE reason:
Description

Pharmacogenetic Test, Informed Consent, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Sample Collection
Description

Sample Collection

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0870078
Has a Sample been collected for PGx Research?
Description

Pharmacogenetic Test, Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0870078
If YES, record a date sample taken
Description

Pharmacogenetic Test, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Withdrawal of Consent
Description

Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C1707492
Has subject withdrawn consent for PGx Research?
Description

Pharmacogenetic Test, Consent withdrawn

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1707492
If YES, record the date informed consentwithdrawn for PGx research
Description

Pharmacogenetic Test, Consent withdrawn, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1707492
UMLS CUI [1,3]
C0011008
Sample Destruction
Description

Sample Destruction

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0178913
UMLS CUI-3
C1948029
Has a request been made for sample destruction?
Description

Pharmacogenetic Test, Blood Specimen, Destruction

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
If YES, choose one reason:
Description

Pharmacogenetic Test, Blood Specimen, Destruction, Indication

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C0392360
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Similar models

Pharmacogenetic (PGx) Research

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Consent for PGx Research
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
Pharmacogenetic Test, Informed Consent
Item
Has consent been obtained for PGx Research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Pharmacogenetic Test, Informed Consent, Date in time
Item
If YES, record the date informed consent obtained for PGx Research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If NO, choose ONE reason:
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
If NO, choose ONE reason:
Code List
If NO, choose ONE reason:
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify_______________ (3)
Item Group
Sample Collection
C2347500 (UMLS CUI-1)
C0870078 (UMLS CUI-2)
Pharmacogenetic Test, Sampling
Item
Has a Sample been collected for PGx Research?
boolean
C2347500 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
Pharmacogenetic Test, Sampling, Date in time
Item
If YES, record a date sample taken
date
C2347500 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Withdrawal of Consent
C2347500 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
Pharmacogenetic Test, Consent withdrawn
Item
Has subject withdrawn consent for PGx Research?
boolean
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Pharmacogenetic Test, Consent withdrawn, Date in time
Item
If YES, record the date informed consentwithdrawn for PGx research
date
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Sample Destruction
C2347500 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C1948029 (UMLS CUI-3)
Pharmacogenetic Test, Blood Specimen, Destruction
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])
Item
If YES, choose one reason:
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
If YES, choose one reason:
Code List
If YES, choose one reason:
CL Item
[1] Subject requested (1)
CL Item
[z] Other, specify_____________ (2)
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