ID

34809

Description

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

Keywords

Versions (1)
  1. 1/30/19 1/30/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 30, 2019

DOI

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License

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

English

PGx-Pharmacogenetic Research Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

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

Consent for PGx-Pharmacogenetic Research

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
Has informed consent been obtained for PGx-Pharmacogenetic 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-Pharmacogenetic 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, check 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
Blood Sample Collection (DNA)
Description

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?
Description

Pharmacogenetic Tests, Collection of blood specimen for laboratory procedure

Data type

boolean

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

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

Data type

date

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
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-Pharmacogenetic research?
Description

Pharmacogenetic Test, Consent withdrawn

Data type

boolean

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

Blood 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, Request

Data type

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
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]
C3146298
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Similar models

PGx-Pharmacogenetic Research Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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