ID
34617
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
Versionen (1)
- 20.01.19 20.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
20. Januar 2019
DOI
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Lizenz
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
Screening Form
- StudyEvent: ODM
Beschreibung
Alcohol Intake
Alias
- UMLS CUI-1
- C0001948
Beschreibung
Alcohol consumption
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
Alcohol consumption; alcohol units/week
Datentyp
float
Maßeinheiten
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschreibung
History of Tobacco Use
Alias
- UMLS CUI-1
- C0841002
Beschreibung
History of tobacco use
Datentyp
text
Alias
- UMLS CUI [1]
- C0841002
Beschreibung
Tobacco use, Last
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C1517741
Beschreibung
number of cigarettes per day
Datentyp
integer
Maßeinheiten
- cigarettes per day
Alias
- UMLS CUI [1]
- C3694146
Beschreibung
Smoking, year, Count of entities
Datentyp
integer
Maßeinheiten
- years
Alias
- UMLS CUI [1,1]
- C0037369
- UMLS CUI [1,2]
- C0439234
- UMLS CUI [1,3]
- C0449788
Beschreibung
Pack Years
Datentyp
integer
Maßeinheiten
- pack years
Alias
- UMLS CUI [1]
- C1277691
Beschreibung
Nicotine Oral Product, Nicotine Topical Product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1270916
- UMLS CUI [1,2]
- C3213077
Beschreibung
Ocular History and Risk Factors
Alias
- UMLS CUI-1
- C1299003
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C0035648
Beschreibung
Cataract, Visual Impairment
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C3665347
Beschreibung
Cataract, Eye
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0015392
Beschreibung
Cataract, risk factors
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086543
- UMLS CUI [1,2]
- C0035648
Beschreibung
Ocular Examination
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C1299003
Beschreibung
Visual Acuity, Right Eye
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0229089
Beschreibung
Visual Acuity, Left eye structure
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042812
- UMLS CUI [1,2]
- C0229090
Beschreibung
Slit lamp biomicroscopy (procedure), Right eye
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C0229089
Beschreibung
Slit lamp biomicroscopy (procedure), Left eye structure
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0419360
- UMLS CUI [1,2]
- C0229090
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
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
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
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
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
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
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
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
Beschreibung
Ophthalmoscopy of posterior and peripheral fundus features
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0029090
- UMLS CUI [1,2]
- C0229089
Beschreibung
Ophthalmoscopy of posterior and peripheral fundus features
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0029090
- UMLS CUI [1,2]
- C0229090
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Body mass index
Datentyp
float
Maßeinheiten
- kg/m2
Alias
- UMLS CUI [1]
- C1305855
Beschreibung
Vital Signs Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826644
Beschreibung
Vital signs, Relative time, Planned
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beschreibung
Vital Signs Time
Datentyp
time
Alias
- UMLS CUI [1]
- C2826762
Beschreibung
Systolic Pressure, Supine Position
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0038846
Beschreibung
Diastolic blood pressure, Supine Position
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0038846
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
12 lead ECG, Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
12 lead ECG, Start time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
12 lead ECG, Ventricular Rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2189285
Beschreibung
12 lead ECG, PR Interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Beschreibung
12 lead ECG, QRS complex duration
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Beschreibung
12 lead ECG, QT interval - finding
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Beschreibung
12 lead ECG, Electrocardiogram QT corrected interval
Datentyp
integer
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Beschreibung
12 lead ECG, QRS Axis
Datentyp
integer
Maßeinheiten
- degrees
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429012
Beschreibung
12 lead ECG, Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschreibung
Urine Drug and Alcohol Screen
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C0038586
Beschreibung
Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0202304
- UMLS CUI [1,3]
- C0870078
- UMLS CUI [1,4]
- C0011008
- UMLS CUI [1,5]
- C0040223
Beschreibung
Urine drug screening, Cocaine
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0009170
Beschreibung
Urine drug screening, Amphetamines
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0002667
Beschreibung
Urine drug screening, Benzodiazepines
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0005064
Beschreibung
Urine drug screening, Cannabinoids
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0006864
Beschreibung
Urine drug screening, Opiates
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0376196
Beschreibung
Urine drug screening, Barbiturates
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0004745
Beschreibung
Urine drug screening, Methadone
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0025605
Beschreibung
Urine drug screening, Ethanol measurement
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202274
- UMLS CUI [1,2]
- C0202304
Beschreibung
Urine Cotinine measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C1278256
Beschreibung
Serology - HIV Screen
Alias
- UMLS CUI-1
- C0036743
- UMLS CUI-2
- C0459958
Beschreibung
HIV screen, Sampling, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0459958
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beschreibung
HIV antibodies
Datentyp
text
Alias
- UMLS CUI [1]
- C0019683
Beschreibung
Hepatitis B Surface Antigens
Datentyp
text
Alias
- UMLS CUI [1]
- C0019168
Beschreibung
Hepatitis C antibody measurement
Datentyp
text
Alias
- UMLS CUI [1]
- C0201487
Beschreibung
Child-Bearing Potential
Alias
- UMLS CUI-1
- C3831118
Beschreibung
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
Electronically transferred laboratory data (Blood) - Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Beschreibung
Chemistry, Clinical; Relative time, Planned
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
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
Beschreibung
Chemistry, Clinical; Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0040223
Beschreibung
Electronically transferred laboratory data (Blood) - Haematology
Alias
- UMLS CUI-1
- C0018941
Beschreibung
Hematologic tests, Relative time, Planned
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
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
Beschreibung
Hematologic tests; Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0040223
Beschreibung
Electronically transferred laboratory data (Urine) - Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschreibung
Urinalysis, Relative time, Planned
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C1301732
Beschreibung
Urinalysis, Sampling, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0870078
- UMLS CUI [1,3]
- C0011008
Beschreibung
Urinalysis, Time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0040223
Ähnliche Modelle
Screening Form
- StudyEvent: ODM
C0560579 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C3213077 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C3665347 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,2])
C1299003 (UMLS CUI-2)
C0229089 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C0521447 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
C0521447 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
C0229092 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
C0229092 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
C0038586 (UMLS CUI-2)
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
C0002667 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
C0006864 (UMLS CUI [1,2])
C0004745 (UMLS CUI [1,2])
C0025605 (UMLS CUI [1,2])
C0202304 (UMLS CUI [1,2])
C0459958 (UMLS CUI-2)
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])