ID

41728

Beschreibung

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be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.

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Versionen (2)
  1. 09.01.21 09.01.21 -
  2. 09.01.21 09.01.21 -
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GlaxoSmithKline

Hochgeladen am

9. Januar 2021

DOI

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

Englisch

Pharmacogenetic Research

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

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

date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
subject ID
Beschreibung

subject ID

Datentyp

text

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

PGx-Pharmacogenetic Research Consent

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

informed consent for pharmacogenetic research

Datentyp

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
Beschreibung

pharmacogenetic research consent, date

Datentyp

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?
Beschreibung

pharmacogenetic research, blood sample

Datentyp

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
Beschreibung

date blood sample taken

Datentyp

date

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

pharmacogenetic research, no consent, reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0566251
if you checked other, please specify:
Beschreibung

pharmacogenetic research, no consent, other reason

Datentyp

text

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C3840932
genetics type
Beschreibung

genetics type

Datentyp

text

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

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?
Beschreibung

withdrawn consent for PGx-Pharmacogenetic research

Datentyp

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?
Beschreibung

pharmacogenetic research, request for sample destruction

Datentyp

boolean

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

pharmacogenetic research, request for sample destruction, reason

Datentyp

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:
Beschreibung

pharmacogenetic research, request for sample destruction, other reason

Datentyp

text

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

genetics type

Datentyp

text

Alias
UMLS CUI [1,1]
C0017399
UMLS CUI [1,2]
C0332307
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Ähnliche Modelle

Pharmacogenetic Research

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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])
Item
if no, please check reason:
text
C0031325 (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 research, no consent, other reason
Item
if you checked other, please specify:
text
C0031325 (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])
genetics type
Item
genetics type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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