ID

34809

Beskrivning

TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia

Nyckelord

Versioner (1)
  1. 2019-01-30 2019-01-30 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 januari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Engelsk

PGx-Pharmacogenetic Research Form

1 Formulär  
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Consent for PGx-Pharmacogenetic Research
Beskrivning

Consent for PGx-Pharmacogenetic Research

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
If Yes, record the 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
If No, check one reason
Beskrivning

Pharmacogenetic Test, Informed Consent, Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0392360
Blood Sample Collection (DNA)
Beskrivning

Blood Sample Collection (DNA)

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0005834
UMLS CUI-3
C0012854
Has a blood sample been collected for PGx-pharmacogenetic research?
Beskrivning

Pharmacogenetic Tests, Collection of blood specimen for laboratory procedure

Datatyp

boolean

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

Pharmacogenetic Tests, 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
Withdrawal of Consent
Beskrivning

Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C1707492
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Beskrivning

Pharmacogenetic Test, Consent withdrawn

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1707492
Blood Sample Destruction
Beskrivning

Blood Sample Destruction

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

Pharmacogenetic Test, Blood Specimen, Destruction, Request

Datatyp

boolean

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

Pharmacogenetic Test, Blood Specimen, Destruction, Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1948029
UMLS CUI [1,4]
C3146298
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Similar models

PGx-Pharmacogenetic Research Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Consent for PGx-Pharmacogenetic Research
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
If Yes, record the date informed consent obtained for PGx-Pharmacogenetic research
date
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If No, check one reason
text
C0031325 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Pharmacogenetic Test, Informed Consent, Indication
Code List
If No, check one reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
Item Group
Blood Sample Collection (DNA)
C2347500 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0012854 (UMLS CUI-3)
Pharmacogenetic Tests, Collection of blood specimen for laboratory procedure
Item
Has a blood sample been collected for PGx-pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacogenetic Tests, Collection of blood specimen for laboratory procedure, Date in time
Item
If Yes, record the date sample taken
date
C2347500 (UMLS CUI [1,1])
C0005834 (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-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Item Group
Blood Sample Destruction
C2347500 (UMLS CUI-1)
C0178913 (UMLS CUI-2)
C1948029 (UMLS CUI-3)
Pharmacogenetic Test, Blood Specimen, Destruction, Request
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
If Yes, check one reason
text
C2347500 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1948029 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,4])
Pharmacogenetic Test, Blood Specimen, Destruction, Indication
Code List
If Yes, check one reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
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