ID

34626

Descripción

TEST StudyStudy ID: 102863 Clinical Study ID: 102863 Study Title: A randomized, open-label, two-period, period-balanced, crossover study with three parallel groups to evaluate the relative bioavailability of single oral doses of SB 497115-GR phase III tablets [50 mg, 75 mg, 100 mg] compared to SB-497115-GR phase II tablets [25 mg and 50 mg] in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Trade Name: Eltrombopag Study Indication: Thrombocytopenia

Palabras clave

Versiones (1)
  1. 20/1/19 20/1/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de enero de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Inglés

Follow-Up Form

1 formularios  
  1. StudyEvent: ODM
    1. Follow-Up Form
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Date of Visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Ocular Examination
Descripción

Ocular Examination

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C1299003
Visual Acuity (Snellen Scale) - OD (right eye)
Descripción

Visual Acuity, Right Eye

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0229089
Visual Acuity (Snellen Scale) - OS (left eye)
Descripción

Visual Acuity, Left eye structure

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0229090
Has there been a change in the subject’s visual acuity since the baseline assessment?
Descripción

Visual Acuity, Changed status

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0443172
If Yes, has this change been due to worsening cataract?
Descripción

Visual Acuity, Changed status, Cataract

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0443172
UMLS CUI [1,3]
C0086543
Slip Lamp Examination - OD
Descripción

Slit lamp biomicroscopy (procedure), Right eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0229089
Slip Lamp Examination - OS
Descripción

Slit lamp biomicroscopy (procedure), Left eye structure

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0229090
Cortical slit lamp examination - OD
Descripción

Slit lamp evaluation of lens using Age-Related Eye Disease Study (AREDS) clinical lens opacity grading protocol for each eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C1176472
UMLS CUI [1,3]
C0229090
Cortical slit lamp examination - OS
Descripción

Slit lamp evaluation of lens using Age-Related Eye Disease Study (AREDS) clinical lens opacity grading protocol for each eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C1176472
UMLS CUI [1,3]
C0229090
Nuclear slit lamp examination - OD
Descripción

Slit lamp evaluation of lens using Age-Related Eye Disease Study (AREDS) clinical lens opacity grading protocol for each eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0521447
UMLS CUI [1,3]
C0229089
Nuclear slit lamp examination - OS
Descripción

Slit lamp evaluation of lens using Age-Related Eye Disease Study (AREDS) clinical lens opacity grading protocol for each eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0521447
UMLS CUI [1,3]
C0229090
Posterior Subcapsular slit lamp examination - OD
Descripción

Slit lamp evaluation of lens using Age-Related Eye Disease Study (AREDS) clinical lens opacity grading protocol for each eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0205095
UMLS CUI [1,3]
C0205152
UMLS CUI [1,4]
C0229089
Posterior Subcapsular slit lamp examination - OS
Descripción

Slit lamp evaluation of lens using Age-Related Eye Disease Study (AREDS) clinical lens opacity grading protocol for each eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0205095
UMLS CUI [1,3]
C0205152
UMLS CUI [1,4]
C0229090
Slit lamp biomicroscopy of posterior pole features for each eye - OD
Descripción

Slit lamp biomicroscopy (procedure), Structure of posterior pole of eye, Right eye

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0229092
UMLS CUI [1,3]
C0229089
Slit lamp biomicroscopy of posterior pole features for each eye - OS
Descripción

Slit lamp biomicroscopy (procedure), Structure of posterior pole of eye, Left eye structure

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0419360
UMLS CUI [1,2]
C0229092
UMLS CUI [1,3]
C0229090
Ophthalmoscopy - OD
Descripción

Ophthalmoscopy of posterior and peripheral fundus features

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0029090
UMLS CUI [1,2]
C0229089
Ophthalmoscopy - OD
Descripción

Ophthalmoscopy of posterior and peripheral fundus features

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0029090
UMLS CUI [1,2]
C0229090
Pregnancy Test
Descripción

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Date sample taken
Descripción

Pregnancy Tests, Sampling, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Results
Descripción

Pregnancy test finding

Tipo de datos

text

Alias
UMLS CUI [1]
C0427777
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Descripción

Electronically transferred laboratory data (Blood) - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Planned Relative Time
Descripción

Chemistry, Clinical; Relative time, Planned

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Descripción

Chemistry, Clinical; Sampling, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Chemistry, Clinical; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data (Blood) - Haematology
Descripción

Electronically transferred laboratory data (Blood) - Haematology

Alias
UMLS CUI-1
C0018941
Planned Relative Time
Descripción

Hematologic tests, Relative time, Planned

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Descripción

Hematologic tests, Sampling, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Hematologic tests; Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0040223
Electronically transferred laboratory data (Urine) - Urinalysis
Descripción

Electronically transferred laboratory data (Urine) - Urinalysis

Alias
UMLS CUI-1
C0042014
Planned Relative Time
Descripción

Urinalysis, Relative time, Planned

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Date Sample Taken
Descripción

Urinalysis, Sampling, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Actual Time
Descripción

Urinalysis, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
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Similar models

Follow-Up Form

1 formularios
  1. StudyEvent: ODM
    1. Follow-Up Form
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Ocular Examination
C0031809 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
Visual Acuity, Right Eye
Item
Visual Acuity (Snellen Scale) - OD (right eye)
integer
C0042812 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Visual Acuity, Left eye structure
Item
Visual Acuity (Snellen Scale) - OS (left eye)
integer
C0042812 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Visual Acuity, Changed status
Item
Has there been a change in the subject’s visual acuity since the baseline assessment?
boolean
C0042812 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Visual Acuity, Changed status, Cataract
Item
If Yes, has this change been due to worsening cataract?
boolean
C0042812 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
C0086543 (UMLS CUI [1,3])
Item
Slip Lamp Examination - OD
text
C0419360 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Slip Lamp Examination - OD
CL Item
Normal (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Slip Lamp Examination - OS
text
C0419360 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Slip Lamp Examination - OS
CL Item
Normal (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Cortical slit lamp examination - OD
text
C0419360 (UMLS CUI [1,1])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Cortical slit lamp examination - OD
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
Cortical slit lamp examination - OS
text
C0419360 (UMLS CUI [1,1])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Cortical slit lamp examination - OS
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
Nuclear slit lamp examination - OD
text
C0419360 (UMLS CUI [1,1])
C0521447 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Nuclear slit lamp examination - OD
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
Nuclear slit lamp examination - OS
text
C0419360 (UMLS CUI [1,1])
C0521447 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Nuclear slit lamp examination - OS
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 slit lamp examination - OD
text
C0419360 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Posterior Subcapsular slit lamp examination - OD
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 slit lamp examination - OS
text
C0419360 (UMLS CUI [1,1])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Posterior Subcapsular slit lamp examination - OS
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
Slit lamp biomicroscopy of posterior pole features for each eye - OD
text
C0419360 (UMLS CUI [1,1])
C0229092 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Slit lamp biomicroscopy of posterior pole features for each eye - OD
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Slit lamp biomicroscopy of posterior pole features for each eye - OS
text
C0419360 (UMLS CUI [1,1])
C0229092 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
Slit lamp biomicroscopy (procedure), Right eye
Code List
Slit lamp biomicroscopy of posterior pole features for each eye - OS
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Ophthalmoscopy - OD
text
C0029090 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Ophthalmoscopy, Right eye
Code List
Ophthalmoscopy - OD
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item
Ophthalmoscopy - OD
text
C0029090 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Ophthalmoscopy, Right eye
Code List
Ophthalmoscopy - OD
CL Item
Normal limits (1)
CL Item
Abnormal, but not affecting vision and not requiring treatment (2)
CL Item
Abnormal, not affecting vision, requiring treatment, Specify (3)
CL Item
Abnormal, affecting vision, Specify (4)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Tests, Sampling, Date in time
Item
Date sample taken
date
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Results
text
C0427777 (UMLS CUI [1])
Pregnancy test finding
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Electronically transferred laboratory data (Blood) - Clinical Chemistry
C0008000 (UMLS CUI-1)
Item
Planned Relative Time
text
C0008000 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
Follow-up (Follow-up)
Chemistry, Clinical; Sampling, Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Chemistry, Clinical; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Blood) - Haematology
C0018941 (UMLS CUI-1)
Item
Planned Relative Time
text
C0018941 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
Follow-up (Follow-up)
Hematologic tests, Sampling, Date in time
Item
Date Sample Taken
date
C0018941 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematologic tests; Time
Item
Actual Time
time
C0018941 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data (Urine) - Urinalysis
C0042014 (UMLS CUI-1)
Item
Planned Relative Time
text
C0042014 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chemistry, Clinical; Relative time, Planned
Code List
Planned Relative Time
CL Item
Follow-up (Follow-up)
Urinalysis, Sampling, Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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