ID

34617

Description

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

Keywords

Versions (1)
  1. 1/20/19 1/20/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 20, 2019

DOI

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License

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

English

Screening Form

1 forms  
  1. StudyEvent: ODM
    1. Screening Form
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Alcohol Intake
Description

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Description

Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1]
C0001948
If Yes, record the average number of units of alcohol1 consumed per week
Description

Alcohol consumption; alcohol units/week

Data type

float

Measurement units
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
History of Tobacco Use
Description

History of Tobacco Use

Alias
UMLS CUI-1
C0841002
What is the subject’s history of tobacco use (includes all tobacco products)?
Description

History of tobacco use

Data type

text

Alias
UMLS CUI [1]
C0841002
Former smoker -> When did the subject last smoke/use tobacco?
Description

Tobacco use, Last

Data type

date

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C1517741
Current or Former smoker -> Average number of cigarettes smoked per day?
Description

number of cigarettes per day

Data type

integer

Measurement units
  • cigarettes per day
Alias
UMLS CUI [1]
C3694146
cigarettes per day
Number of years during which the subject has smoked/used tobacco?
Description

Smoking, year, Count of entities

Data type

integer

Measurement units
  • years
Alias
UMLS CUI [1,1]
C0037369
UMLS CUI [1,2]
C0439234
UMLS CUI [1,3]
C0449788
years
Number of pack years?
Description

Pack Years

Data type

integer

Measurement units
  • pack years
Alias
UMLS CUI [1]
C1277691
pack years
Is the subject currently using a nicotine oral regimen or topical application (e.g., gum, patches, etc.)?
Description

Nicotine Oral Product, Nicotine Topical Product

Data type

boolean

Alias
UMLS CUI [1,1]
C1270916
UMLS CUI [1,2]
C3213077
Ocular History and Risk Factors
Description

Ocular History and Risk Factors

Alias
UMLS CUI-1
C1299003
UMLS CUI-2
C0262926
UMLS CUI-3
C0035648
Subject has visually significant cataracts?
Description

Cataract, Visual Impairment

Data type

boolean

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C3665347
If Yes, check relevant boxes below
Description

Cataract, Eye

Data type

text

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0015392
Subject has the following cataract risk factors
Description

Cataract, risk factors

Data type

text

Alias
UMLS CUI [1,1]
C0086543
UMLS CUI [1,2]
C0035648
Ocular Examination
Description

Ocular Examination

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

Visual Acuity, Right Eye

Data type

integer

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

Visual Acuity, Left eye structure

Data type

integer

Alias
UMLS CUI [1,1]
C0042812
UMLS CUI [1,2]
C0229090
Slip Lamp Examination - OD
Description

Slit lamp biomicroscopy (procedure), Right eye

Data type

text

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

Slit lamp biomicroscopy (procedure), Left eye structure

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

text

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

Ophthalmoscopy of posterior and peripheral fundus features

Data type

text

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

Ophthalmoscopy of posterior and peripheral fundus features

Data type

text

Alias
UMLS CUI [1,1]
C0029090
UMLS CUI [1,2]
C0229090
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Date
Description

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Description

Vital signs, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Actual Time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure Supine - Systolic
Description

Systolic Pressure, Supine Position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Blood Pressure Supine - Diastolic
Description

Diastolic blood pressure, Supine Position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Start Date of ECG
Description

12 lead ECG, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start time of ECG
Description

12 lead ECG, Start time

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Description

12 lead ECG, Ventricular Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C2189285
bpm
PR Interval
Description

12 lead ECG, PR Interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Description

12 lead ECG, QRS complex duration

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Description

12 lead ECG, QT interval - finding

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Description

12 lead ECG, Electrocardiogram QT corrected interval

Data type

integer

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
QRS Axis, if available
Description

12 lead ECG, QRS Axis

Data type

integer

Measurement units
  • degrees
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429012
degrees
Result of the ECG
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Urine Drug and Alcohol Screen
Description

Urine Drug and Alcohol Screen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0038586
Date and time of sample taken
Description

Urine drug screening, Ethanol measurement, Sampling, Date in time, Time

Data type

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
Cocaine
Description

Urine drug screening, Cocaine

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Amphetamines
Description

Urine drug screening, Amphetamines

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
Benzodiazepines
Description

Urine drug screening, Benzodiazepines

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cannabinoids
Description

Urine drug screening, Cannabinoids

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Opiates
Description

Urine drug screening, Opiates

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0376196
Barbiturates
Description

Urine drug screening, Barbiturates

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Methadone
Description

Urine drug screening, Methadone

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0025605
Alcohol
Description

Urine drug screening, Ethanol measurement

Data type

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0202304
Cotinine
Description

Urine Cotinine measurement

Data type

text

Alias
UMLS CUI [1]
C1278256
Serology - HIV Screen
Description

Serology - HIV Screen

Alias
UMLS CUI-1
C0036743
UMLS CUI-2
C0459958
Date sample taken
Description

HIV screen, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0459958
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
HIV antibody
Description

HIV antibodies

Data type

text

Alias
UMLS CUI [1]
C0019683
Hepatitis B surface antigen
Description

Hepatitis B Surface Antigens

Data type

text

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Description

Hepatitis C antibody measurement

Data type

text

Alias
UMLS CUI [1]
C0201487
Child-Bearing Potential
Description

Child-Bearing Potential

Alias
UMLS CUI-1
C3831118
Child-Bearing Potential
Description

Childbearing Potential

Data type

text

Alias
UMLS CUI [1]
C3831118
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Date sample taken
Description

Pregnancy Tests, Sampling, Date in time

Data type

date

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

Pregnancy test finding

Data type

text

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

Electronically transferred laboratory data (Blood) - Clinical Chemistry

Alias
UMLS CUI-1
C0008000
Planned Relative Time
Description

Chemistry, Clinical; Relative time, Planned

Data type

text

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

Chemistry, Clinical; Sampling, Date in time

Data type

date

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

Chemistry, Clinical; Time

Data type

time

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

Electronically transferred laboratory data (Blood) - Haematology

Alias
UMLS CUI-1
C0018941
Planned Relative Time
Description

Hematologic tests, Relative time, Planned

Data type

text

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

Hematologic tests, Sampling, Date in time

Data type

date

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

Hematologic tests; Time

Data type

time

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

Electronically transferred laboratory data (Urine) - Urinalysis

Alias
UMLS CUI-1
C0042014
Planned Relative Time
Description

Urinalysis, Relative time, Planned

Data type

text

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

Urinalysis, Sampling, Date in time

Data type

date

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

Urinalysis, Time

Data type

time

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

Screening Form

1 forms
  1. StudyEvent: ODM
    1. Screening Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Alcohol Intake
C0001948 (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])
Item Group
History of Tobacco Use
C0841002 (UMLS CUI-1)
Item
What is the subject’s history of tobacco use (includes all tobacco products)?
text
C0841002 (UMLS CUI [1])
History of tobacco use
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])
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])
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])
Item Group
Ocular History and Risk Factors
C1299003 (UMLS CUI-1)
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])
Item
If Yes, check relevant boxes below
text
C0086543 (UMLS CUI [1,1])
C0015392 (UMLS CUI [1,2])
Cataract, Eye
Code List
If Yes, check relevant boxes below
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])
Cataract, risk factors
Code List
Subject has the following cataract risk factors
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)
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])
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
Vital Signs
C0518766 (UMLS CUI-1)
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])
Vital signs, Relative time, Planned
Code List
Planned Relative Time
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])
Diastolic blood pressure, Supine Position
Item
Blood Pressure Supine - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
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])
12 lead ECG, Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
12 lead ECG, PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
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])
12 lead ECG, QT interval - finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
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])
12 lead ECG, QRS Axis
Item
QRS Axis, if available
integer
C0430456 (UMLS CUI [1,1])
C0429012 (UMLS CUI [1,2])
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result of the ECG
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)
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])
Item
Cocaine
text
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
C0202274 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methadone
text
C0202274 (UMLS CUI [1,1])
C0025605 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Methadone
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
text
C0202274 (UMLS CUI [1,1])
C0202304 (UMLS CUI [1,2])
Urine drug screening, Cocaine
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cotinine
text
C1278256 (UMLS CUI [1])
Urine drug screening, Cocaine
Code List
Cotinine
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Serology - HIV Screen
C0036743 (UMLS CUI-1)
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])
Item
HIV antibody
text
C0019683 (UMLS CUI [1])
HIV antibodies
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
text
C0019168 (UMLS CUI [1])
Hepatitis B Surface Antigens
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
text
C0201487 (UMLS CUI [1])
Hepatitis B Surface Antigens
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Child-Bearing Potential
C3831118 (UMLS CUI-1)
Item
Child-Bearing Potential
text
C3831118 (UMLS CUI [1])
Childbearing Potential
Code List
Child-Bearing Potential
CL Item
Post-menopausal (1)
CL Item
Sterile (of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
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
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])
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
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])
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
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])
Urinalysis, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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