ID

41655

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 at the Screening Visit.

Keywords

Versions (2)
  1. 12/1/20 12/1/20 -
  2. 12/4/20 12/4/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 4, 2020

DOI

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License

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

English

Demography

1 forms  
  1. StudyEvent: ODM
    1. Demography
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit
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
Randomization
Description

Randomization

Alias
UMLS CUI-1
C0034656
was the subject able to be randomised?
Description

if yes, please provide the randomisation number and date below.

Data type

boolean

Alias
UMLS CUI [1]
C0034656
randomisation number
Description

randomisation number

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
date of randomisation
Description

date of randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
date of birth
Description

date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
sex
Description

sex

Data type

text

Alias
UMLS CUI [1]
C0079399
if female: record child bearing potential
Description

child bearing potential

Data type

text

Alias
UMLS CUI [1]
C3831118
ethnicity
Description

ethnicity

Data type

text

Alias
UMLS CUI [1]
C0015031
race: african american/african heritage
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
race: american indian or alaskan native
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1515945
race: asian - central/south asian heritage
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
race: asian - japanese heritage
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1556094
race: asian - south east asian heritage
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0238697
race: native hawaiian or other pacific islander
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1513907
race: white - arabic/north aftrican heritage
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
race: white - white/caucasian/european heritage
Description

check all that apply

Data type

boolean

Alias
UMLS CUI [1]
C1535514
UMLS CUI [2]
C0043157
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Similar models

Demography

1 forms
  1. StudyEvent: ODM
    1. Demography
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1320722 (UMLS CUI-1)
date of visit
Item
date of visit
date
C1320303 (UMLS CUI [1])
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Randomization
C0034656 (UMLS CUI-1)
randomisation
Item
was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1])
randomisation number
Item
randomisation number
text
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
date of randomisation
Item
date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
C0011298 (UMLS CUI-1)
date of birth
Item
date of birth
date
C0421451 (UMLS CUI [1])
Item
sex
text
C0079399 (UMLS CUI [1])
sex
Code List
sex
CL Item
male (1)
(Comment:en)
CL Item
female  (2)
(Comment:en)
Item
if female: record child bearing potential
text
C3831118 (UMLS CUI [1])
child bearing potential
Code List
if female: record child bearing potential
CL Item
pre-menarchial (1)
CL Item
post-menopausal (2)
CL Item
sterile (of childbearing age) (3)
CL Item
potentially able to bear children (4)
Item
ethnicity
text
C0015031 (UMLS CUI [1])
ethnicity
Code List
ethnicity
CL Item
Hispanic or Latino (1)
(Comment:en)
CL Item
Not Hispanic or Latino (2)
(Comment:en)
african american/african heritage
Item
race: african american/african heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
american indian or alaskan native
Item
race: american indian or alaskan native
boolean
C1515945 (UMLS CUI [1])
asian - central/south asian heritage
Item
race: asian - central/south asian heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
asian - japanese heritage
Item
race: asian - japanese heritage
boolean
C1556094 (UMLS CUI [1])
asian - south east asian heritage
Item
race: asian - south east asian heritage
boolean
C0238697 (UMLS CUI [1])
native hawaiian or other pacific islander
Item
race: native hawaiian or other pacific islander
boolean
C1513907 (UMLS CUI [1])
white - arabic/north aftrican heritage
Item
race: white - arabic/north aftrican heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
white - white/caucasian/european heritage
Item
race: white - white/caucasian/european heritage
boolean
C1535514 (UMLS CUI [1])
C0043157 (UMLS CUI [2])
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