Informações:
Falhas:
ID
34617
Descrição
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
Palavras-chave
Versões (1)
- 20/01/2019 20/01/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
20 de janeiro de 2019
DOI
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Licença
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
Similar models
Screening Form
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Alcohol consumption; alcohol units/week
Item
If Yes, record the average number of units of alcohol1 consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
Item
What is the subject’s history of tobacco use (includes all tobacco products)?
text
C0841002 (UMLS CUI [1])
Code List
What is the subject’s history of tobacco use (includes all tobacco products)?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Tobacco use, Last
Item
Former smoker -> When did the subject last smoke/use tobacco?
date
C0543414 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
number of cigarettes per day
Item
Current or Former smoker -> Average number of cigarettes smoked per day?
integer
C3694146 (UMLS CUI [1])
Smoking, year, Count of entities
Item
Number of years during which the subject has smoked/used tobacco?
integer
C0037369 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Pack Years
Item
Number of pack years?
integer
C1277691 (UMLS CUI [1])
Nicotine Oral Product, Nicotine Topical Product
Item
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
boolean
C1270916 (UMLS CUI [1,1])
C3213077 (UMLS CUI [1,2])
C3213077 (UMLS CUI [1,2])
Item Group
Ocular History and Risk Factors
C1299003 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
Cataract, Visual Impairment
Item
Subject has visually significant cataracts?
boolean
C0086543 (UMLS CUI [1,1])
C3665347 (UMLS CUI [1,2])
C3665347 (UMLS CUI [1,2])
Item
If Yes, check relevant boxes below
text
C0086543 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,2])
CL Item
OD (right eye) (OD (right eye))
CL Item
OS (left eye) (OS (left eye))
Item
Subject has the following cataract risk factors
text
C0086543 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C0035648 (UMLS CUI [1,2])
CL Item
Chronic steroid use (1)
CL Item
Family history of cataract at a young (< 60 yo) age (2)
CL Item
History of radiation treatment to the head or orbit (3)
CL Item
Diabetes mellitus (4)
CL Item
History of intraocular surgery (5)
CL Item
History of ocular disease requiring medical treatment (6)
CL Item
Serious eye trauma (7)
CL Item
Chronic occupational exposure to UV light (8)
CL Item
Gout (9)
CL Item
Cigarette use (10)
CL Item
Alcohol abuse (11)
CL Item
Other (12)
Item Group
Ocular Examination
C0031809 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
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])
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])
C0229090 (UMLS CUI [1,2])
Item
Slip Lamp Examination - OD
text
C0419360 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,2])
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])
C0229090 (UMLS CUI [1,2])
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])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
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])
C1176472 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
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])
C0521447 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
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])
C0521447 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
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])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
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])
C0205095 (UMLS CUI [1,2])
C0205152 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
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])
C0229092 (UMLS CUI [1,2])
C0229089 (UMLS CUI [1,3])
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])
C0229092 (UMLS CUI [1,2])
C0229090 (UMLS CUI [1,3])
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])
C0229089 (UMLS CUI [1,2])
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])
C0229090 (UMLS CUI [1,2])
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)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Vital Signs Date
Item
Date
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Screening (Screening)
Vital Signs Time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Pressure, Supine Position
Item
Blood Pressure Supine - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic blood pressure, Supine Position
Item
Blood Pressure Supine - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
12 lead ECG, Start time
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
12 lead ECG, PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
12 lead ECG, QRS complex duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
12 lead ECG, QT interval - finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
12 lead ECG, Electrocardiogram QT corrected interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
12 lead ECG, QRS Axis
Item
QRS Axis, if available
integer
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
C0429012 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Urine Drug and Alcohol Screen
C0373483 (UMLS CUI-1)
C0038586 (UMLS CUI-2)
C0038586 (UMLS CUI-2)
Urine drug screening, Ethanol measurement, Sampling, Date in time, Time
Item
Date and time of sample taken
datetime
C0202274 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
C0202304 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
C0002667 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
C0006864 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
C0004745 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methadone
text
C0202274 (UMLS CUI [1,1])
C0025605 (UMLS CUI [1,2])
C0025605 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
text
C0202274 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
C0202304 (UMLS CUI [1,2])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Serology - HIV Screen
C0036743 (UMLS CUI-1)
C0459958 (UMLS CUI-2)
C0459958 (UMLS CUI-2)
HIV screen, Sampling, Date in time
Item
Date sample taken
date
C0459958 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Post-menopausal (1)
CL Item
Sterile (of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
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])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Screening (Screening)
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])
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])
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])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Screening (Screening)
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])
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])
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])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
CL Item
Screening (Screening)
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])
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])
C0040223 (UMLS CUI [1,2])