ID

39292

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. 12/17/19 12/17/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 17, 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

Follow-up

1 forms  
  1. StudyEvent: ODM
    1. Follow-up
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
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
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
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Description

Physical Examination, Assessment Date

Data type

date

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

Physical Examination, body system or organ function

Data type

text

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

Physical Examination, Test Result

Data type

text

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

Physical Examination, Comment

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0947611
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
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
Electronically Transferred Laboratory Data (Haematology)
Description

Electronically Transferred Laboratory Data (Haematology)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
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)
Description

Electronically Transferred Laboratory Data (Clinical Chemistry)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
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)
Description

Electronically Transferred Laboratory Data (Urinalysis)

Alias
UMLS CUI-1
C0042014
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 Blood Monitoring)
Description

Electronically Transferred Laboratory Data (Renal Blood Monitoring)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0232804
UMLS CUI-3
C0005767
Date Sample Taken
Description

Laboratory Procedures, Renal function, Blood, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0011008
Actual Time
Description

Laboratory Procedures, Renal function, Blood, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0040223
Electronically Transferred Laboratory Data (Renal Urine Monitoring)
Description

Electronically Transferred Laboratory Data (Renal Urine Monitoring)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0232804
UMLS CUI-3
C0042036
Date Sample Taken
Description

Laboratory Procedures, Renal function, Urine, Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0011008
Actual Time
Description

Laboratory Procedures, Renal function, Urine, Sampling, Time

Data type

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0040223
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Similar models

Follow-up

1 forms
  1. StudyEvent: ODM
    1. Follow-up
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
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
Follow-up (1)
CL Item
Follow-up (2)
CL Item
Unscheduled (3)
CL Item
Unscheduled (4)
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])
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)
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
Follow-up (1)
CL Item
Follow-up (2)
CL Item
Follow-up (3)
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)
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
Follow-up (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
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
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination, Assessment Date
Item
Date of Assessment
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item
Physical Examination
text
C0031809 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
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])
C0456984 (UMLS CUI [1,2])
Physical Examination, Test Result
Code List
Result
CL Item
Normal (1)
CL Item
Not Done (2)
CL Item
Not Done (2)
Physical Examination, Comment
Item
Comment
text
C0031809 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item Group
Electronically Transferred Laboratory Data (Haematology)
C0022885 (UMLS CUI-1)
C0474523 (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])
Item Group
Electronically Transferred Laboratory Data (Clinical Chemistry)
C0022885 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
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)
C0042014 (UMLS CUI-1)
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 Blood Monitoring)
C0022885 (UMLS CUI-1)
C0232804 (UMLS CUI-2)
C0005767 (UMLS CUI-3)
Laboratory Procedures, Renal function, Blood, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Laboratory Procedures, Renal function, Blood, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item Group
Electronically Transferred Laboratory Data (Renal Urine Monitoring)
C0022885 (UMLS CUI-1)
C0232804 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
Laboratory Procedures, Renal function, Urine, Sampling, Date in time
Item
Date Sample Taken
date
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Laboratory Procedures, Renal function, Urine, Sampling, Time
Item
Actual Time
time
C0022885 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
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