ID

41677

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 at the Screening and Follow-Up Visits.

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  1. 12.12.20 12.12.20 -
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GlaxoSmithKline

Hochgeladen am

12. Dezember 2020

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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122

Englisch

Slit lamp, Biomicrosopy, Visual acuity and indirect ophthalmoscopy

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
date of visit
Beschreibung

date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
subject ID
Beschreibung

subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
visit type
Beschreibung

visit type

Datentyp

text

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

slit lamp examination

Alias
UMLS CUI-1
C0419360
actual date
Beschreibung

actual date of slit lamp examination

Datentyp

date

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

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

Datentyp

text

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

slit lamp examination

Datentyp

text

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

abnormal, not affecting vision and requiring treatment, specification

Datentyp

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:
Beschreibung

abnormal, affecting vision, specification

Datentyp

text

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

slit lamp examination: cortical examination

Datentyp

text

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

slit lamp examination: nuclear examination

Datentyp

text

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

slit lamp examination: posterior subcapsular examination

Datentyp

text

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

slit lamp biomicroscopy

Alias
UMLS CUI-1
C0419360
actual date
Beschreibung

actual date of slit lamp biomicroscopy

Datentyp

date

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

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

Datentyp

text

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

slit lamp biomicroscopy

Datentyp

text

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

abnormal, not affecting vision and requiring treatment, specification

Datentyp

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:
Beschreibung

abnormal, affecting vision, specification

Datentyp

text

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

visual acuity

Alias
UMLS CUI-1
C0042812
actual date
Beschreibung

actual date of visual acuity examination

Datentyp

date

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

visual acuity: right eye

Datentyp

text

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

visual acuity: left eye

Datentyp

text

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

change in visual acuity since the baseline assessment

Datentyp

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?
Beschreibung

change in visual acuity due to worsening cataract

Datentyp

boolean

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

Indirect Ophtalmoscopy

Alias
UMLS CUI-1
C1444582
actual date
Beschreibung

actual date of indirect ophtalmoscopy

Datentyp

date

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

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

Datentyp

text

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

indirect ophtalmoscopy

Datentyp

text

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

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

Datentyp

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:
Beschreibung

indirect ophtalmoscopy abnormal, affecting vision, specification

Datentyp

text

Alias
UMLS CUI [1,1]
C1444582
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C3665347
UMLS CUI [3]
C2348235
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Ähnliche Modelle

Slit lamp, Biomicrosopy, Visual acuity and indirect ophthalmoscopy

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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