ID

41732

Description

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.

Keywords

Versions (2)
  1. 1/9/21 1/9/21 -
  2. 1/9/21 1/9/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 2021

DOI

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License

Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

English

Pharmacogenetic Research

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit/assessment
Description

date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
subject ID
Description

subject ID

Data type

text

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

PGx-Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
has informed consent been obtained for PGx-Pharmacogenetic research?
Description

informed consent for pharmacogenetic research

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
if yes, please provide the date informed consent obtained for PGx-Pharmacogenetic research
Description

pharmacogenetic research consent, date

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
if yes, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
Description

pharmacogenetic research, blood sample

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C2347500
if a blood sample has been taken, please record the date the sample was taken
Description

date blood sample taken, pharmacogenetic test

Data type

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C2347500
if no, please check reason:
Description

pharmacogenetic tests, no consent, reason

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0566251
if you checked other, please specify:
Description

pharmacogenetic tests, no consent, other reason

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C3840932
genetics type
Description

genetics type

Data type

text

Alias
UMLS CUI [1,1]
C0017399
UMLS CUI [1,2]
C0332307
PGx-Pharmacogenetic Research Withdrawal of Consent
Description

PGx-Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-2
C0021430
UMLS CUI-3
C2349954
has subject withdrawn consent for PGx-Pharmacogenetic research?
Description

withdrawn consent for PGx-Pharmacogenetic research

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C2349954
has a request been made for sample destruction?
Description

pharmacogenetic research, request for sample destruction

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
if yes, please check reason:
Description

pharmacogenetic research, request for sample destruction, reason

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0566251
if other, please specify:
Description

pharmacogenetic research, request for sample destruction, other reason

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C3840932
genetics type
Description

pharmacogenetic tests, genetics type

Data type

text

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0017399
UMLS CUI [1,3]
C0332307
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Similar models

Pharmacogenetic Research

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
date of visit
Item
date of visit/assessment
date
C1320303 (UMLS CUI [1])
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item Group
PGx-Pharmacogenetic Research Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
informed consent for pharmacogenetic research
Item
has informed consent been obtained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
pharmacogenetic research consent, date
Item
if yes, please provide the date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
pharmacogenetic research, blood sample
Item
if yes, has a blood sample been collected for PGx-pharmacogenetic (DNA) research?
boolean
C1277698 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
date blood sample taken, pharmacogenetic test
Item
if a blood sample has been taken, please record the date the sample was taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
Item
if no, please check reason:
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
pharmacogenetic research, no consent, reason
Code List
if no, please check reason:
CL Item
subject declined (1)
CL Item
subject not asked by Investigator (2)
CL Item
other (3)
pharmacogenetic tests, no consent, other reason
Item
if you checked other, please specify:
text
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
genetics type
Item
genetics type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
PGx-Pharmacogenetic Research Withdrawal of Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
withdrawn consent for PGx-Pharmacogenetic research
Item
has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
pharmacogenetic research, request for sample destruction
Item
has a request been made for sample destruction?
boolean
C2347500 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Item
if yes, please check reason:
text
C2347500 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
pharmacogenetic research, request for sample destruction, reason
Code List
if yes, please check reason:
CL Item
subject requested  (1)
CL Item
screen failure (2)
CL Item
other (3)
pharmacogenetic research, request for sample destruction, other reason
Item
if other, please specify:
text
C2347500 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
pharmacogenetic tests, genetics type
Item
genetics type
text
C2347500 (UMLS CUI [1,1])
C0017399 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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