ID

39310

Description

Study ID: 110771 Clinical Study ID: 110771 Study Title: An open label positron emission tomography (PET) study to investigate brain penetration by [carbonyl-11C] GSK1034702 in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Positron Emission Tomography Trade Name: Carbonyl-11C Study Indication: Cognitive Disorders, Alzheimer's disease, schizophrenia.

Keywords

Versions (1)
  1. 12/18/19 12/18/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 18, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Brain Penetration by [Carbonyl-11C] GSK1034702; 110771

English

Day 1 RE-TEST

1 forms  
  1. StudyEvent: ODM
    1. Day 1 RE-TEST
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
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Allen's Test
Description

Allen's Test

Alias
UMLS CUI-1
C0231664
Was an Allen's Test performed?
Description

Allen test

Data type

boolean

Alias
UMLS CUI [1]
C0231664
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
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 - Systolic
Description

Systolic Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood Pressure - Diastolic
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject Position
Description

Vital signs, Body position

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1262869
Heart Rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature - Oral
Description

Body Temperature, Oral

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
Respiration Rate
Description

Respiratory rate

Data type

integer

Measurement units
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Pulmonary Function Tests
Description

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Date
Description

Pulmonary function tests, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
Test
Description

Pulmonary function tests

Data type

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0011008
Units
Description

Pulmonary function tests, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1519795
Planned Relative Time
Description

Pulmonary function tests, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C1519795
Pulmonary Function Time
Description

Pulmonary function tests, Time

Data type

time

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0040223
Reading 1
Description

Pulmonary function tests, Result

Data type

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0040223
Reading 2
Description

Pulmonary function tests, Result

Data type

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0040223
Reading 3
Description

Pulmonary function tests, Result

Data type

text

Alias
UMLS CUI [1,1]
C0024119
UMLS CUI [1,2]
C0040223
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Description

12 lead ECG, Numbers

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Description

12 lead ECG, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time
Description

12 lead ECG, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start Time of ECG
Description

12 lead ECG, Start time

Data type

time

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

12 lead ECG, Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
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

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
Result of the ECG
Description

12 lead ECG, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
24Hrs Summary Holter
Description

24Hrs Summary Holter

Alias
UMLS CUI-1
C0013801
Start Date of Holter
Description

Holter Electrocardiography, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start time of Holter
Description

Holter Electrocardiography, Start time

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop date of Holter
Description

Holter Electrocardiography, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Stop time of Holter
Description

Holter Electrocardiography, End time

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Interpretation of Holter
Description

Holter Electrocardiography, Clinical Interpretation

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C4086187
Holter monitoring method
Description

Holter Electrocardiography, Test Method

Data type

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
PET Scan - Pre-Dose
Description

PET Scan - Pre-Dose

Alias
UMLS CUI-1
C0032743
UMLS CUI-2
C0439565
Date of Scan
Description

Positron-Emission Tomography, Pre-dose, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C0011008
Name of Tracer
Description

Positron-Emission Tomography, Pre-dose, Tracer

Data type

text

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
Radiochemical Purity at Release
Description

Positron-Emission Tomography, Pre-dose, Tracer, Radiopharmaceuticals, drug purity

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0182638
UMLS CUI [1,5]
C0678739
%
Radiochemical purity time at release
Description

Positron-Emission Tomography, Pre-dose, Tracer, Time

Data type

time

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0040223
Mass of Tracer Administered
Description

Positron-Emission Tomography, Pre-dose, Tracer, Molecular Mass

Data type

float

Measurement units
  • ug
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C3152252
ug
Volume to be Administered (inc diluent)
Description

Positron-Emission Tomography, Pre-dose, Tracer, Volume

Data type

float

Measurement units
  • mL
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0449468
mL
Bolus Activity Injected
Description

Positron-Emission Tomography, Pre-dose, Tracer, Radioactivity

Data type

float

Measurement units
  • MBq/mL
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0034553
MBq/mL
Start Time of Bolus Injection
Description

Positron-Emission Tomography, Pre-dose, Tracer, Injection of therapeutic agent, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0021485
UMLS CUI [1,5]
C1301880
Duration of Bolus Injection
Description

Positron-Emission Tomography, Pre-dose, Tracer, Injection of therapeutic agent, Duration

Data type

time

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0021485
UMLS CUI [1,5]
C2926735
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
Planned Relative Time
Description

Pharmacokinetic aspects, Blood, Relative time, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0439564
UMLS CUI [1,4]
C1301732
Date Sample Taken
Description

Pharmacokinetic aspects, Blood, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Pharmacokinetic aspects, Blood, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Sample Number
Description

Pharmacokinetic aspects, Blood, Sampling, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0237753
Randomisation Number
Description

Randomisation Number

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number.
Description

Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Treatment Confirmation
Description

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Description

Therapeutic procedure, Correct

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
If No, record reason(s)
Description

Therapeutic procedure, Wrong, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0566251
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint
Description

Experimental drug, Timepoint, Planned

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1301732
Date of Actual Dose
Description

Experimental drug, Dosage, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Actual Dose
Description

Experimental drug, Dosage, Time

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Actual Dose
Description

Experimental drug, Dosage

Data type

float

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
Units
Description

Experimental drug, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1519795
PET Scan - Post-Dose
Description

PET Scan - Post-Dose

Alias
UMLS CUI-1
C0032743
UMLS CUI-2
C0439568
Date of Scan
Description

Positron-Emission Tomography, Post-dose, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0011008
Name of Tracer
Description

Positron-Emission Tomography, Post-dose, Tracer

Data type

text

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1522485
Radiochemical Purity at Release
Description

Positron-Emission Tomography, Pre-dose, Tracer, Radiopharmaceuticals, drug purity

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439565
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0182638
UMLS CUI [1,5]
C0678739
%
Radiochemical purity time at release
Description

Positron-Emission Tomography, Post-dose, Tracer, Time

Data type

time

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0040223
Mass of Tracer Administered
Description

Positron-Emission Tomography, Post-dose, Tracer, Molecular Mass

Data type

float

Measurement units
  • ug
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C3152252
ug
Volume to be Administered (inc diluent)
Description

Positron-Emission Tomography, Post-dose, Tracer, Volume

Data type

float

Measurement units
  • mL
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0449468
mL
Bolus Activity Injected
Description

Positron-Emission Tomography, Post-dose, Tracer, Radioactivity

Data type

float

Measurement units
  • MBq/mL
Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0034553
MBq/mL
Start Time of Bolus Injection
Description

Positron-Emission Tomography, Post-dose, Tracer, Injection of therapeutic agent, Start Time

Data type

time

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0021485
UMLS CUI [1,5]
C1301880
Duration of Bolus Injection
Description

Positron-Emission Tomography, Post-dose, Tracer, Injection of therapeutic agent, Duration

Data type

time

Alias
UMLS CUI [1,1]
C0032743
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C1522485
UMLS CUI [1,4]
C0021485
UMLS CUI [1,5]
C2926735
Physical Examination - 24Hrs Post-Dose
Description

Physical Examination - 24Hrs Post-Dose

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0439568
Date of Assessment
Description

Physical Examination, Post-dose, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C2985720
Physical Examination
Description

Physical Examination, Post-dose, body system or organ function

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0678852
Result
Description

Physical Examination, Post-dose, Test Result

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0456984
Comment
Description

Physical Examination, Post-dose, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0439568
UMLS CUI [1,3]
C0947611
Vital Signs - 24Hrs Post-Dose
Description

Vital Signs - 24Hrs Post-Dose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0439568
Weight
Description

Body Weight, Post-dose

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439568
kg
Body mass index
Description

Body mass index, Post-dose

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0439568
kg/m2
Body weight >= 50kg and BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
Description

Body Weight; Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Electronically Transferred Laboratory Data (Haematology) - 24Hrs Post-dose
Description

Electronically Transferred Laboratory Data (Haematology) - 24Hrs Post-dose

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0439568
UMLS CUI-3
C0474523
Date Sample Taken
Description

Laboratory Procedures, Hematology finding, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Hematology finding, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0474523
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Electronically Transferred Laboratory Data (Clinical Chemistry) -24Hrs Post-Dose
Description

Electronically Transferred Laboratory Data (Clinical Chemistry) -24Hrs Post-Dose

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0439568
UMLS CUI-3
C0008000
Date Sample Taken
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Electronically Transferred Laboratory Data (Urinalysis) -24Hrs Post-Dose
Description

Electronically Transferred Laboratory Data (Urinalysis) -24Hrs Post-Dose

Alias
UMLS CUI-1
C0042014
UMLS CUI-2
C0439568
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, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Electronically Transferred Laboratory Data (Renal Monitoring) - 24Hrs Post-Dose
Description

Electronically Transferred Laboratory Data (Renal Monitoring) - 24Hrs Post-Dose

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0439568
UMLS CUI-3
C0232804
Date Sample Taken
Description

Laboratory Procedures, Renal function, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0011008
Actual Time
Description

Laboratory Procedures, Renal function, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
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Day 1 RE-TEST

1 forms
  1. StudyEvent: ODM
    1. Day 1 RE-TEST
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])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Allen's Test
C0231664 (UMLS CUI-1)
Allen test
Item
Was an Allen's Test performed?
boolean
C0231664 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (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
Pre-dose (1)
CL Item
Pre-dose (2)
CL Item
Pre-dose (3)
CL Item
Pre-dose (4)
CL Item
Pre-dose (5)
CL Item
Pre-dose (6)
CL Item
15 mins (7)
CL Item
15 mins (8)
CL Item
30 mins (9)
CL Item
30 mins (10)
CL Item
1 hr (11)
CL Item
1 hr (12)
CL Item
1.5 hrs (13)
CL Item
1.5 hrs (14)
CL Item
2 hrs (15)
CL Item
2 hrs (16)
CL Item
2.5 hrs (17)
CL Item
2.5 hrs (18)
CL Item
3 hrs (19)
CL Item
3 hrs (20)
CL Item
4 hrs (21)
CL Item
4 hrs (22)
CL Item
6 hrs (23)
CL Item
6 hrs (24)
CL Item
8 hrs (25)
CL Item
8 hrs (26)
CL Item
12 hrs (27)
CL Item
12 hrs (28)
CL Item
24 hrs (29)
CL Item
24 hrs (30)
CL Item
Unscheduled (31)
CL Item
Unscheduled (32)
CL Item
Unscheduled (33)
CL Item
Unscheduled (34)
CL Item
Unscheduled (35)
CL Item
Unscheduled (36)
CL Item
Unscheduled (37)
CL Item
Unscheduled (38)
CL Item
Unscheduled (39)
CL Item
Unscheduled (40)
CL Item
Unscheduled (41)
CL Item
Unscheduled (42)
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])
Vital signs, Body position
Code List
Subject Position
CL Item
Standing (1)
CL Item
Semi-supine (2)
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])
Item Group
Pulmonary Function Tests
C0024119 (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])
Pulmonary function tests
Code List
Test
CL Item
FEV1 (1)
CL Item
VC/FVC (2)
CL Item
FEV1/VC (3)
CL Item
FEV1 (4)
CL Item
VC/FVC (5)
CL Item
FEV1/VC (6)
CL Item
FEV1 (7)
CL Item
VC/FVC (8)
CL Item
FEV1/VC (9)
Item
Units
text
C0024119 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Disease, Current or past
Code List
Units
Item
Planned Relative Time
text
C0024119 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Disease, Current or past
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
Pre-dose (2)
CL Item
Pre-dose (3)
CL Item
3 hrs (4)
CL Item
3 hrs (5)
CL Item
3 hrs (6)
CL Item
24 hrs (7)
CL Item
24 hrs (8)
CL Item
24 hrs (9)
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 Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
text
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
12 lead ECG, Numbers
Code List
ECG Number
CL Item
ECG1 (1)
CL Item
ECG2 (2)
CL Item
ECG3 (3)
CL Item
ECG4 (4)
CL Item
ECG5 (5)
CL Item
ECG6 (6)
CL Item
ECG7 (7)
CL Item
ECG8 (8)
CL Item
ECG1 (9)
CL Item
ECG2 (10)
CL Item
ECG3 (11)
CL Item
ECG4 (12)
CL Item
ECG5 (13)
CL Item
ECG6 (14)
CL Item
ECG7 (15)
CL Item
ECG8 (16)
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])
12 lead ECG, Relative time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
Pre-dose (2)
CL Item
Pre-dose (3)
CL Item
1 hr (4)
CL Item
1.5 hrs (5)
CL Item
2 hrs (6)
CL Item
2.5 hrs (7)
CL Item
3 hrs (8)
CL Item
4 hrs (9)
CL Item
6 hrs (10)
CL Item
8 hrs (11)
CL Item
12 hrs (12)
CL Item
24 hrs (13)
CL Item
Unscheduled (14)
CL Item
Unscheduled (15)
CL Item
Unscheduled (16)
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])
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
24Hrs Summary Holter
C0013801 (UMLS CUI-1)
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])
Holter Electrocardiography, Clinical Interpretation
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant  (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item
Holter monitoring method
text
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
Holter Electrocardiography, Test Method
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
Telemetry (4)
CL Item
5 Lead 512Hz (5)
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)
CL Item
Other (11)
Item Group
PET Scan - Pre-Dose
C0032743 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
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])
Positron-Emission Tomography, Pre-dose, Tracer
Code List
Name of Tracer
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 Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
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])
Pharmacokinetic aspects, Blood, Relative time, Planned
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
1 hrs (2)
CL Item
2 hrs (3)
CL Item
3 hrs (4)
CL Item
4 hrs (5)
CL Item
5.5 hrs (6)
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])
Item Group
Randomisation Number
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomization, Numbers
Item
Record randomisation number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-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])
Serologic tests, HIV screen
Code List
If No, record reason(s)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned Timepoint
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental drug, Timepoint, Planned
Code List
Planned Timepoint
CL Item
Day 1 (1)
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])
Item Group
PET Scan - Post-Dose
C0032743 (UMLS CUI-1)
C0439568 (UMLS CUI-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])
Positron-Emission Tomography, Pre-dose, Tracer
Code List
Name of Tracer
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])
Item Group
Physical Examination - 24Hrs Post-Dose
C0031809 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
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])
Physical Examination, Test Result
Code List
Physical Examination
CL Item
Hair and skin (1)
CL Item
Lymph nodes (2)
CL Item
Eyes (3)
CL Item
Ears, Nose and Throat (4)
CL Item
Breasts (5)
CL Item
Respiratory (6)
CL Item
Cardiovascular (7)
CL Item
Abdomen (8)
CL Item
Urogenital (9)
CL Item
Pelvic (10)
CL Item
Rectal (11)
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, Test Result
Code List
Result
CL Item
Normal (1)
CL Item
Not Done (2)
CL Item
Not Done (2)
Physical Examination, Post-dose, Comment
Item
Comment
text
C0031809 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item Group
Vital Signs - 24Hrs Post-Dose
C0518766 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
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])
Item Group
Electronically Transferred Laboratory Data (Haematology) - 24Hrs Post-dose
C0022885 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0474523 (UMLS CUI-3)
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])
Item Group
Electronically Transferred Laboratory Data (Clinical Chemistry) -24Hrs Post-Dose
C0022885 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
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])
Item Group
Electronically Transferred Laboratory Data (Urinalysis) -24Hrs Post-Dose
C0042014 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
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])
Item Group
Electronically Transferred Laboratory Data (Renal Monitoring) - 24Hrs Post-Dose
C0022885 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C0232804 (UMLS CUI-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])
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