ID

34626

Beschreibung

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

Stichworte

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  1. 20.01.19 20.01.19 -
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GlaxoSmithKline

Hochgeladen am

20. Januar 2019

DOI

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Relative Bioavailability of SB 497115-GR phase III tablets compared to SB-497115-GR phase II tablets 102863

Englisch

Follow-Up Form

1 Formulare  
  1. StudyEvent: ODM
    1. Follow-Up Form
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Ocular Examination
Beschreibung

Ocular Examination

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

Visual Acuity, Right Eye

Datentyp

integer

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

Visual Acuity, Left eye structure

Datentyp

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?
Beschreibung

Visual Acuity, Changed status

Datentyp

boolean

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

Visual Acuity, Changed status, Cataract

Datentyp

boolean

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

Slit lamp biomicroscopy (procedure), Right eye

Datentyp

text

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

Slit lamp biomicroscopy (procedure), Left eye structure

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

text

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

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

text

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

Ophthalmoscopy of posterior and peripheral fundus features

Datentyp

text

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

Ophthalmoscopy of posterior and peripheral fundus features

Datentyp

text

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

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Date sample taken
Beschreibung

Pregnancy Tests, Sampling, Date in time

Datentyp

date

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

Pregnancy test finding

Datentyp

text

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

Electronically transferred laboratory data (Blood) - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Planned Relative Time
Beschreibung

Chemistry, Clinical; Relative time, Planned

Datentyp

text

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

Chemistry, Clinical; Sampling, Date in time

Datentyp

date

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

Chemistry, Clinical; Time

Datentyp

time

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

Electronically transferred laboratory data (Blood) - Haematology

Alias
UMLS CUI-1
C0018941
Planned Relative Time
Beschreibung

Hematologic tests, Relative time, Planned

Datentyp

text

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

Hematologic tests, Sampling, Date in time

Datentyp

date

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

Hematologic tests; Time

Datentyp

time

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

Electronically transferred laboratory data (Urine) - Urinalysis

Alias
UMLS CUI-1
C0042014
Planned Relative Time
Beschreibung

Urinalysis, Relative time, Planned

Datentyp

text

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

Urinalysis, Sampling, Date in time

Datentyp

date

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

Urinalysis, Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
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Ähnliche Modelle

Follow-Up Form

1 Formulare
  1. StudyEvent: ODM
    1. Follow-Up Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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