ID

39292

Descripción

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.

Palabras clave

  1. 17/12/19 17/12/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de diciembre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

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Brain Penetration by [Carbonyl-11C] GSK1034702; 110771

  1. StudyEvent: ODM
    1. Follow-up
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Descripción

Vital Signs Date

Tipo de datos

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Descripción

Vital signs, Relative time, Planned

Tipo de datos

text

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

Vital Signs Time

Tipo de datos

time

Alias
UMLS CUI [1]
C2826762
Blood Pressure - Systolic
Descripción

Systolic Pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood Pressure - Diastolic
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject Position
Descripción

Vital signs, Body position

Tipo de datos

text

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

Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Respiration Rate
Descripción

Respiratory rate

Tipo de datos

integer

Unidades de medida
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Pulmonary Function Tests
Descripción

Pulmonary Function Tests

Alias
UMLS CUI-1
C0024119
Date
Descripción

Pulmonary function tests, Date in time

Tipo de datos

date

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

Pulmonary function tests

Tipo de datos

text

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

Pulmonary function tests, Unit of Measure

Tipo de datos

text

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

Pulmonary function tests, Relative time, Planned

Tipo de datos

text

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

Pulmonary function tests, Time

Tipo de datos

time

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

Pulmonary function tests, Result

Tipo de datos

text

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

Pulmonary function tests, Result

Tipo de datos

text

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

Pulmonary function tests, Result

Tipo de datos

text

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

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Descripción

12 lead ECG, Numbers

Tipo de datos

text

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

12 lead ECG, Start Date

Tipo de datos

date

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

12 lead ECG, Relative time, Planned

Tipo de datos

text

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

12 lead ECG, Start time

Tipo de datos

time

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

12 lead ECG, Heart rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
bpm
PR Interval
Descripción

12 lead ECG, PR interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429087
msec
QRS Duration
Descripción

12 lead ECG, QRS complex duration

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0429025
msec
Uncorrected QT Interval
Descripción

12 lead ECG, QT interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1287082
msec
QTc Interval
Descripción

12 lead ECG, Electrocardiogram QT corrected interval

Tipo de datos

integer

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0855331
msec
Result of the ECG
Descripción

12 lead ECG, Result

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Physical Examination
Descripción

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Descripción

Physical Examination, Assessment Date

Tipo de datos

date

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

Physical Examination, body system or organ function

Tipo de datos

text

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

Physical Examination, Test Result

Tipo de datos

text

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

Physical Examination, Comment

Tipo de datos

text

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Weight
Descripción

Body Weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Descripción

Body mass index

Tipo de datos

float

Unidades de medida
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Electronically Transferred Laboratory Data (Haematology)
Descripción

Electronically Transferred Laboratory Data (Haematology)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date Sample Taken
Descripción

Laboratory Procedures, Hematology finding, Sampling, Date in time

Tipo de datos

date

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

Laboratory Procedures, Hematology finding, Sampling, Time

Tipo de datos

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)
Descripción

Electronically Transferred Laboratory Data (Clinical Chemistry)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0008000
Date Sample Taken
Descripción

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

Tipo de datos

date

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

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Tipo de datos

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)
Descripción

Electronically Transferred Laboratory Data (Urinalysis)

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Descripción

Urinalysis, Sampling, Date in time

Tipo de datos

date

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

Urinalysis, Sampling, Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Electronically Transferred Laboratory Data (Renal Blood Monitoring)
Descripción

Electronically Transferred Laboratory Data (Renal Blood Monitoring)

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

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

Tipo de datos

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
Descripción

Laboratory Procedures, Renal function, Blood, Sampling, Time

Tipo de datos

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)
Descripción

Electronically Transferred Laboratory Data (Renal Urine Monitoring)

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

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

Tipo de datos

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
Descripción

Laboratory Procedures, Renal function, Urine, Sampling, Time

Tipo de datos

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

Similar models

Follow-up

  1. StudyEvent: ODM
    1. Follow-up
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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])
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])
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])
Item
Planned Relative Time
text
C0024119 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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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