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be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.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)
- 1/9/21 1/9/21 -
- 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
Pharmacogenetic Research
- StudyEvent: ODM
Description
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
Description
informed consent for pharmacogenetic research
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Description
pharmacogenetic research consent, date
Data type
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Description
pharmacogenetic research, blood sample
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C2347500
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
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
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
Description
genetics type
Data type
text
Alias
- UMLS CUI [1,1]
- C0017399
- UMLS CUI [1,2]
- C0332307
Description
PGx-Pharmacogenetic Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
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
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
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
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
Description
pharmacogenetic tests, genetics type
Data type
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0017399
- UMLS CUI [1,3]
- C0332307
Similar models
Pharmacogenetic Research
- StudyEvent: ODM
C0021430 (UMLS CUI-2)
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
C0017399 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])