ID

41676

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, a follow-up visit, a logs and repeats visit, a PGx visit and a visit for the common CRF. 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 (1)
  1. 12/12/20 12/12/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 12, 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

Ocular History and Risk Factors

1 forms  
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
ocular history and risk factors
Description

ocular history and risk factors

Alias
UMLS CUI-1
C1299003
UMLS CUI-2
C0262926
UMLS CUI-4
C1299003
UMLS CUI-5
C0035648
date of examination
Description

if different from date of visit

Data type

date

Alias
UMLS CUI [1,1]
C0582103
UMLS CUI [1,2]
C0011008
patient has visually significant cataracts
Description

visually significant cataracts

Data type

text

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C3665347
patient has the following cataract risk factors
Description

patient has the following cataract risk factors

Alias
UMLS CUI-1
C0035648
UMLS CUI-2
C0086543
chronic steroid use
Description

chronic steroid use

Data type

boolean

Alias
UMLS CUI [1,1]
C0281991
UMLS CUI [1,2]
C0205191
family history of cataract at a young (<60yo) age
Description

family history of cataract at a young age

Data type

boolean

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0241889
UMLS CUI [1,3]
C1833334
history of radiation treatment to the head or orbit
Description

history of radiation treatment to the head or orbit

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0029180
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C1522449
UMLS CUI [2,3]
C0018670
diabetes mellitus
Description

diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
history of intraocular surgery
Description

history of intraocular surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C3282905
history of ocular disease requiring medical treatment
Description

history of ocular disease requiring medical treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0015397
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0087111
serious eye trauma
Description

serious eye trauma

Data type

boolean

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C0015408
chronic occupational exposure to UV light
Description

chronic occupational exposure to UV light

Data type

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C0521127
UMLS CUI [1,3]
C0332157
UMLS CUI [1,4]
C0041625
gout
Description

gout

Data type

boolean

Alias
UMLS CUI [1]
C0018099
cigarette use
Description

cigarette use

Data type

boolean

Alias
UMLS CUI [1]
C0694535
alcohol abuse
Description

alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
other cataract risk factor
Description

other cataract risk factor

Data type

boolean

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0205394
if other cataract risk factor, please specify:
Description

if other cataract risk factor, please specify:

Data type

text

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
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Similar models

Ocular History and Risk Factors

1 forms
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
C1299003 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C1299003 (UMLS CUI-4)
C0035648 (UMLS CUI-5)
date of examination
Item
date of examination
date
C0582103 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
patient has visually significant cataracts
text
C0086543 (UMLS CUI [1,1])
C3665347 (UMLS CUI [1,2])
visually significant cataracts
Code List
patient has visually significant cataracts
CL Item
No (N)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Right Eye (OD)
C0229089 (UMLS CUI-1)
(Comment:en)
CL Item
Left Eye (OS)
C0229090 (UMLS CUI-1)
(Comment:en)
CL Item
Both Eyes (OU)
C0229118 (UMLS CUI-1)
(Comment:en)
Item Group
patient has the following cataract risk factors
C0035648 (UMLS CUI-1)
C0086543 (UMLS CUI-2)
chronic steroid use
Item
chronic steroid use
boolean
C0281991 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
family history of cataract at a young age
Item
family history of cataract at a young (<60yo) age
boolean
C0086543 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C1833334 (UMLS CUI [1,3])
history of radiation treatment to the head or orbit
Item
history of radiation treatment to the head or orbit
boolean
C0262926 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0029180 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C1522449 (UMLS CUI [2,2])
C0018670 (UMLS CUI [2,3])
diabetes mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
history of intraocular surgery
Item
history of intraocular surgery
boolean
C0262926 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C3282905 (UMLS CUI [1,3])
history of ocular disease requiring medical treatment
Item
history of ocular disease requiring medical treatment
boolean
C0262926 (UMLS CUI [1,1])
C0015397 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
serious eye trauma
Item
serious eye trauma
boolean
C0205404 (UMLS CUI [1,1])
C0015408 (UMLS CUI [1,2])
chronic occupational exposure to UV light
Item
chronic occupational exposure to UV light
boolean
C0205191 (UMLS CUI [1,1])
C0521127 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
C0041625 (UMLS CUI [1,4])
gout
Item
gout
boolean
C0018099 (UMLS CUI [1])
cigarette use
Item
cigarette use
boolean
C0694535 (UMLS CUI [1])
alcohol abuse
Item
alcohol abuse
boolean
C0085762 (UMLS CUI [1])
other cataract risk factor
Item
other cataract risk factor
boolean
C0086543 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
if other cataract risk factor, please specify:
Item
if other cataract risk factor, please specify:
text
C0086543 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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