Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Allen test
Item
Was an Allen's Test performed?
boolean
C0231664 (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])
Code List
Planned Relative Time
Vital Signs Time
Item
Actual Time
time
C2826762 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure - Diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
text
C0518766 (UMLS CUI [1,1])
C1262869 (UMLS CUI [1,2])
Code List
Subject Position
Heart rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Body Temperature, Oral
Item
Temperature - Oral
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
Respiratory rate
Item
Respiration Rate
integer
C0231832 (UMLS CUI [1])
Pulmonary function tests, Date in time
Item
Date
date
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Test
text
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Units
text
C0024119 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0024119 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Planned Relative Time
Pulmonary function tests, Time
Item
Pulmonary Function Time
time
C0024119 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Pulmonary function tests, Result
Item
Reading 1
text
C0024119 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Pulmonary function tests, Result
Item
Reading 2
text
C0024119 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Pulmonary function tests, Result
Item
Reading 3
text
C0024119 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
ECG Number
text
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG, Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Code List
Planned Relative Time
12 lead ECG, Start time
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12 lead ECG, Heart rate
Item
Heart Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (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
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])
Item
Result of the ECG
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Result of the ECG
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Holter Electrocardiography, Start Date
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Holter Electrocardiography, Start time
Item
Start time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Holter Electrocardiography, End Date
Item
Stop date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Holter Electrocardiography, End time
Item
Stop time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
Code List
Interpretation of Holter
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
Unable to evaluate (5)
Item
Holter monitoring method
text
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 lead 180Hz (2)
CL Item
3 Lead 180 Hz (3)
CL Item
4 Lead 0.05-40 Hz (6)
CL Item
6 Lead 0.05-40 Hz (7)
CL Item
7 Lead 0.05-100 Hz-3dB (8)
CL Item
7 Lead 3 channel 133 Hz (9)
CL Item
2 Lead 200 Hz (10)
Positron-Emission Tomography, Pre-dose, Date in time
Item
Date of Scan
date
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Name of Tracer
text
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
CL Item
[11C] GSK1034702 (1)
Positron-Emission Tomography, Pre-dose, Tracer, Radiopharmaceuticals, drug purity
Item
Radiochemical Purity at Release
integer
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0182638 (UMLS CUI [1,4])
C0678739 (UMLS CUI [1,5])
Positron-Emission Tomography, Pre-dose, Tracer, Time
Item
Radiochemical purity time at release
time
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Positron-Emission Tomography, Pre-dose, Tracer, Molecular Mass
Item
Mass of Tracer Administered
float
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C3152252 (UMLS CUI [1,4])
Positron-Emission Tomography, Pre-dose, Tracer, Volume
Item
Volume to be Administered (inc diluent)
float
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0449468 (UMLS CUI [1,4])
Positron-Emission Tomography, Pre-dose, Tracer, Radioactivity
Item
Bolus Activity Injected
float
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0034553 (UMLS CUI [1,4])
Positron-Emission Tomography, Pre-dose, Tracer, Injection of therapeutic agent, Start Time
Item
Start Time of Bolus Injection
time
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,4])
C1301880 (UMLS CUI [1,5])
Positron-Emission Tomography, Pre-dose, Tracer, Injection of therapeutic agent, Duration
Item
Duration of Bolus Injection
time
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,4])
C2926735 (UMLS CUI [1,5])
Item
Planned Relative Time
text
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Code List
Planned Relative Time
Pharmacokinetic aspects, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sampling, Numbers
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,4])
Randomization, Numbers
Item
Record randomisation number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Therapeutic procedure, Correct
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
If No, record reason(s)
Item
Planned Timepoint
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Code List
Planned Timepoint
Experimental drug, Dosage, Date in time
Item
Date of Actual Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental drug, Dosage, Time
Item
Time of Actual Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Experimental drug, Dosage
Item
Actual Dose
float
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Experimental drug, Unit of Measure
Item
Units
text
C0304229 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Positron-Emission Tomography, Post-dose, Date in time
Item
Date of Scan
date
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Name of Tracer
text
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
CL Item
[11C] GSK1034702 (1)
Positron-Emission Tomography, Pre-dose, Tracer, Radiopharmaceuticals, drug purity
Item
Radiochemical Purity at Release
integer
C0032743 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0182638 (UMLS CUI [1,4])
C0678739 (UMLS CUI [1,5])
Positron-Emission Tomography, Post-dose, Tracer, Time
Item
Radiochemical purity time at release
time
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Positron-Emission Tomography, Post-dose, Tracer, Molecular Mass
Item
Mass of Tracer Administered
float
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C3152252 (UMLS CUI [1,4])
Positron-Emission Tomography, Post-dose, Tracer, Volume
Item
Volume to be Administered (inc diluent)
float
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0449468 (UMLS CUI [1,4])
Positron-Emission Tomography, Post-dose, Tracer, Radioactivity
Item
Bolus Activity Injected
float
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0034553 (UMLS CUI [1,4])
Positron-Emission Tomography, Post-dose, Tracer, Injection of therapeutic agent, Start Time
Item
Start Time of Bolus Injection
time
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,4])
C1301880 (UMLS CUI [1,5])
Positron-Emission Tomography, Post-dose, Tracer, Injection of therapeutic agent, Duration
Item
Duration of Bolus Injection
time
C0032743 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C1522485 (UMLS CUI [1,3])
C0021485 (UMLS CUI [1,4])
C2926735 (UMLS CUI [1,5])
Physical Examination, Post-dose, Assessment Date
Item
Date of Assessment
date
C0031809 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Item
Physical Examination
text
C0031809 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0678852 (UMLS CUI [1,3])
Code List
Physical Examination
CL Item
Hair and skin (1)
CL Item
Ears, Nose and Throat (4)
CL Item
Cardiovascular (7)
CL Item
Musculoskeletal (12)
CL Item
Neurological (13)
CL Item
Mental status (14)
Item
Result
text
C0031809 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
Physical Examination, Post-dose, Comment
Item
Comment
text
C0031809 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Body Weight, Post-dose
Item
Weight
float
C0005910 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Body mass index, Post-dose
Item
Body mass index
float
C1305855 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Body Weight; Body mass index
Item
Body weight >= 50kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Laboratory Procedures, Hematology finding, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Hematology finding, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Chemistry, Clinical, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
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, Sampling, Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Laboratory Procedures, Renal function, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Laboratory Procedures, Renal function, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])