ID

41677

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 and Follow-Up Visits.

Mots-clés

Versions (1)
  1. 12/12/2020 12/12/2020 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

12 décembre 2020

DOI

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Licence

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

Anglais

Slit lamp, Biomicrosopy, Visual acuity and indirect ophthalmoscopy

1 Formulaires  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit
Description

date of visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
subject ID
Description

subject ID

Type de données

text

Alias
UMLS CUI [1]
C2348585
visit type
Description

visit type

Type de données

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
slit lamp examination
Description

slit lamp examination

Alias
UMLS CUI-1
C0419360
actual date
Description

actual date of slit lamp examination

Type de données

date

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0011008
slit lamp examination; side of eye
Description

all of the following items have to be filled out for both eye sides

Type de données

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0419360
slit lamp examination
Description

slit lamp examination

Type de données

text

Alias
UMLS CUI [1]
C0419360
if abnormal, not affecting vision and requiring treatment, please specify:
Description

abnormal, not affecting vision and requiring treatment, specification

Type de données

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0042789
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0087111
UMLS CUI [4]
C2348235
if abnormal, affecting vision, please specify:
Description

abnormal, affecting vision, specification

Type de données

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C3665347
UMLS CUI [3]
C2348235
cortical
Description

slit lamp examination: cortical examination

Type de données

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C2938874
nuclear
Description

slit lamp examination: nuclear examination

Type de données

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C2938873
posterior subcapsular
Description

slit lamp examination: posterior subcapsular examination

Type de données

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C4228349
slit lamp biomicroscopy
Description

slit lamp biomicroscopy

Alias
UMLS CUI-1
C0419360
actual date
Description

actual date of slit lamp biomicroscopy

Type de données

date

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0011008
slit lamp biomicroscopy; side of eye
Description

all of the following items have to be filled out for both eye sides

Type de données

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0419360
slit lamp biomicroscopy
Description

slit lamp biomicroscopy

Type de données

text

Alias
UMLS CUI [1]
C0419360
if abnormal, not affecting vision and requiring treatment, please specify:
Description

abnormal, not affecting vision and requiring treatment, specification

Type de données

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0042789
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0087111
UMLS CUI [4]
C2348235
if abnormal, affecting vision, please specify:
Description

abnormal, affecting vision, specification

Type de données

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C3665347
UMLS CUI [3]
C2348235
visual acuity
Description

visual acuity

Alias
UMLS CUI-1
C0042812
actual date
Description

actual date of visual acuity examination

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042812
UMLS CUI [1,3]
C0031809
right eye
Description

visual acuity: right eye

Type de données

text

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0229089
left eye
Description

visual acuity: left eye

Type de données

text

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0229090
change in visual acuity since the baseline assessment
Description

change in visual acuity since the baseline assessment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C1442488
if yes, has this change in visual acuity been due to worsening of cataract?
Description

change in visual acuity due to worsening cataract

Type de données

boolean

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C0086543
Indirect Ophtalmoscopy
Description

Indirect Ophtalmoscopy

Alias
UMLS CUI-1
C1444582
actual date
Description

actual date of indirect ophtalmoscopy

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1444582
indirect ophtalmoscopy; side of eye
Description

all of the following items have to be filled out for both eye sides

Type de données

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C1444582
indirect ophtalmoscopy
Description

indirect ophtalmoscopy

Type de données

text

Alias
UMLS CUI [1]
C1444582
indirect ophtalmoscopy abnormal, not affecting vision and requiring treatment, please specify:
Description

indirect ophtalmoscopy abnormal, not affecting vision and requiring treatment, specification

Type de données

text

Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0042789
UMLS CUI [2,2]
C0205307
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0087111
UMLS CUI [4]
C2348235
if abnormal, affecting vision, please specify:
Description

indirect ophtalmoscopy abnormal, affecting vision, specification

Type de données

text

Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C3665347
UMLS CUI [3]
C2348235
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Similar models

Slit lamp, Biomicrosopy, Visual acuity and indirect ophthalmoscopy

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
visit type
Code List
visit type
CL Item
Screening (1)
CL Item
Follow-Up (2)
Item Group
slit lamp examination
C0419360 (UMLS CUI-1)
actual date of slit lamp examination
Item
actual date
date
C0419360 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
slit lamp examination; side of eye
text
C0015392 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0419360 (UMLS CUI [1,3])
eye side
Code List
slit lamp examination; side of eye
CL Item
right eye (r)
CL Item
left eye (l)
Item
slit lamp examination
text
C0419360 (UMLS CUI [1])
right eye
Code List
slit lamp examination
CL Item
within normal limits  (1)
(Comment:en)
CL Item
abnormal, but not affecting vision and not requiring treatment (2)
(Comment:en)
CL Item
abnormal, not affecting vision and requiring treatment (3)
(Comment:en)
CL Item
abnormal, affecting vision (4)
(Comment:en)
abnormal, not affecting vision and requiring treatment, specification
Item
if abnormal, not affecting vision and requiring treatment, please specify:
text
C0419360 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0042789 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C2348235 (UMLS CUI [4])
abnormal, affecting vision, specification
Item
if abnormal, affecting vision, please specify:
text
C0419360 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C3665347 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
cortical
text
C0419360 (UMLS CUI [1,1])
C2938874 (UMLS CUI [1,2])
right eye - cortical
Code List
cortical
CL Item
<1,0 (1)
(Comment:en)
CL Item
1,0-1,9 (2)
(Comment:en)
CL Item
2,0-2,9 (3)
(Comment:en)
CL Item
3,0-3,9 (4)
(Comment:en)
CL Item
4,0 or worse (5)
(Comment:en)
CL Item
aphakia or pseudophakia (6)
(Comment:en)
CL Item
unable to evaluate (7)
(Comment:en)
Item
nuclear
text
C0419360 (UMLS CUI [1,1])
C2938873 (UMLS CUI [1,2])
nuclear examination
Code List
nuclear
CL Item
<1,0 (1)
CL Item
1,0-1,9 (2)
CL Item
2,0-2,9 (3)
CL Item
3,0-3,9 (4)
CL Item
4,0 or worse (5)
CL Item
aphakia or pseudophakia (6)
CL Item
unable to evaluate (7)
Item
posterior subcapsular
text
C0419360 (UMLS CUI [1,1])
C4228349 (UMLS CUI [1,2])
nuclear examination
Code List
posterior subcapsular
CL Item
<1,0 (1)
CL Item
1,0-1,9 (2)
CL Item
2,0-2,9 (3)
CL Item
3,0-3,9 (4)
CL Item
4,0 or worse (5)
CL Item
aphakia or pseudophakia (6)
CL Item
unable to evaluate (7)
Item Group
slit lamp biomicroscopy
C0419360 (UMLS CUI-1)
actual date of slit lamp biomicroscopy
Item
actual date
date
C0419360 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
slit lamp biomicroscopy; side of eye
text
C0015392 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0419360 (UMLS CUI [1,3])
eye side
Code List
slit lamp biomicroscopy; side of eye
CL Item
right eye (r)
CL Item
left eye (l)
Item
slit lamp biomicroscopy
text
C0419360 (UMLS CUI [1])
right eye
Code List
slit lamp biomicroscopy
CL Item
within normal limits  (1)
(Comment:en)
CL Item
abnormal, but not affecting vision and not requiring treatment (2)
(Comment:en)
CL Item
abnormal, not affecting vision and requiring treatment (3)
(Comment:en)
CL Item
abnormal, affecting vision (4)
(Comment:en)
abnormal, not affecting vision and requiring treatment, specification
Item
if abnormal, not affecting vision and requiring treatment, please specify:
text
C0419360 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0042789 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C2348235 (UMLS CUI [4])
abnormal, affecting vision, specification
Item
if abnormal, affecting vision, please specify:
text
C0419360 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C3665347 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
C0042812 (UMLS CUI-1)
actual date of visual acuity examination
Item
actual date
date
C0011008 (UMLS CUI [1,1])
C0042812 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
Item
right eye
text
C0042812 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
visual acuity: right eye
Code List
right eye
CL Item
20/15 (1)
CL Item
20/20 (2)
CL Item
20/25 (3)
CL Item
20/30 (4)
CL Item
20/32 (5)
CL Item
20/40 (6)
CL Item
20/50 (7)
CL Item
20/60 (8)
CL Item
20/70 (9)
CL Item
20/80 (10)
CL Item
20/100 (11)
CL Item
20/125 (12)
CL Item
20/150 (13)
CL Item
20/200 (14)
CL Item
20/250 (15)
CL Item
20/300 (16)
CL Item
20/400 (17)
CL Item
worse than 20/400 (18)
Item
left eye
text
C0042812 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
visual acuity: right eye
Code List
left eye
CL Item
20/15 (1)
CL Item
20/20 (2)
CL Item
20/25 (3)
CL Item
20/30 (4)
CL Item
20/32 (5)
CL Item
20/40 (6)
CL Item
20/50 (7)
CL Item
20/60 (8)
CL Item
20/70 (9)
CL Item
20/80 (10)
CL Item
20/100 (11)
CL Item
20/125 (12)
CL Item
20/150 (13)
CL Item
20/200 (14)
CL Item
20/250 (15)
CL Item
20/300 (16)
CL Item
20/400 (17)
CL Item
worse than 20/400 (18)
change in visual acuity since the baseline assessment
Item
change in visual acuity since the baseline assessment
boolean
C0042812 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
change in visual acuity due to worsening cataract
Item
if yes, has this change in visual acuity been due to worsening of cataract?
boolean
C0042812 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0086543 (UMLS CUI [1,3])
Item Group
Indirect Ophtalmoscopy
C1444582 (UMLS CUI-1)
actual date of indirect ophtalmoscopy
Item
actual date
date
C0011008 (UMLS CUI [1,1])
C1444582 (UMLS CUI [1,2])
Item
indirect ophtalmoscopy; side of eye
text
C0015392 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C1444582 (UMLS CUI [1,3])
eye side
Code List
indirect ophtalmoscopy; side of eye
CL Item
right eye (r)
CL Item
left eye (l)
Item
indirect ophtalmoscopy
text
C1444582 (UMLS CUI [1])
right eye
Code List
indirect ophtalmoscopy
CL Item
within normal limits  (1)
(Comment:en)
CL Item
abnormal, but not affecting vision and not requiring treatment (2)
(Comment:en)
CL Item
abnormal, not affecting vision and requiring treatment (3)
(Comment:en)
CL Item
abnormal, affecting vision (4)
(Comment:en)
indirect ophtalmoscopy abnormal, not affecting vision and requiring treatment, specification
Item
indirect ophtalmoscopy abnormal, not affecting vision and requiring treatment, please specify:
text
C1444582 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0042789 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C2348235 (UMLS CUI [4])
indirect ophtalmoscopy abnormal, affecting vision, specification
Item
if abnormal, affecting vision, please specify:
text
C1444582 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C3665347 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
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