ID

39273

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 15-12-19 15-12-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 december 2019

DOI

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Licentie

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

Engels

Day -1

1 Formulieren  
  1. StudyEvent: ODM
    1. Day -1
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschrijving

Clinical Trial Subject Unique Identifier

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschrijving

Vital Signs Date

Datatype

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beschrijving

Vital signs, Relative time, Planned

Datatype

text

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

Vital Signs Time

Datatype

time

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

Systolic Pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Blood Pressure - Diastolic
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Subject Position
Beschrijving

Vital signs, Body position

Datatype

text

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

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Temperature - Oral
Beschrijving

Body Temperature, Oral

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
24Hrs Summary Holter
Beschrijving

24Hrs Summary Holter

Alias
UMLS CUI-1
C0013801
Start Date of Holter
Beschrijving

Holter Electrocardiography, Start Date

Datatype

date

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

Holter Electrocardiography, Start time

Datatype

time

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

Holter Electrocardiography, End Date

Datatype

date

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

Holter Electrocardiography, End time

Datatype

time

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

Holter Electrocardiography, Clinical Interpretation

Datatype

text

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

Holter Electrocardiography, Test Method

Datatype

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0871511
Physical Examination
Beschrijving

Physical Examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beschrijving

Physical Examination, Assessment Date

Datatype

date

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

Physical Examination, body system or organ function

Datatype

text

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

Physical Examination, Test Result

Datatype

text

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

Physical Examination, Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0947611
Drug and Alcohol Screen
Beschrijving

Drug and Alcohol Screen

Alias
UMLS CUI-1
C0202274
UMLS CUI-2
C0202304
Date and time of sample taken
Beschrijving

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

Datatype

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
Beschrijving

Urine drug screening, Cocaine

Datatype

text

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

Urine drug screening, Amphetamines

Datatype

text

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

Urine drug screening, Benzodiazepines

Datatype

text

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

Urine drug screening, Cannabis

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0936079
Opiates
Beschrijving

Urine drug screening, Opiates

Datatype

text

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

Urine drug screening, Barbiturates

Datatype

text

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Alcohol
Beschrijving

Ethanol measurement

Datatype

text

Alias
UMLS CUI [1]
C0202304
Smokerlyser Breath Test
Beschrijving

Smokerlyser Breath Test

Alias
UMLS CUI-1
C2207180
Date sample taken
Beschrijving

breath test expired carbon monoxide, Sampling, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C2207180
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
Results
Beschrijving

breath test expired carbon monoxide, Result

Datatype

text

Alias
UMLS CUI [1,1]
C2207180
UMLS CUI [1,2]
C1274040
Electronically Transferred Laboratory Data (Haematology)
Beschrijving

Electronically Transferred Laboratory Data (Haematology)

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

Laboratory Procedures, Hematology finding, Sampling, Date in time

Datatype

date

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

Laboratory Procedures, Hematology finding, Sampling, Time

Datatype

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)
Beschrijving

Electronically Transferred Laboratory Data (Clinical Chemistry)

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

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

Datatype

date

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

Laboratory Procedures, Chemistry, Clinical, Sampling, Time

Datatype

time

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0870078
UMLS CUI [1,4]
C0040223
Urinalysis
Beschrijving

Urinalysis

Alias
UMLS CUI-1
C0042014
Date Sample Taken
Beschrijving

Urinalysis, Sampling, Date in time

Datatype

date

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

Urinalysis, Sampling, Time

Datatype

time

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

Electronically Transferred Laboratory Data (Renal Blood Monitoring)

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

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

Datatype

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
Beschrijving

Laboratory Procedures, Renal function, Blood, Sampling, Time

Datatype

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)
Beschrijving

Electronically Transferred Laboratory Data (Renal Urine Monitoring)

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

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

Datatype

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
Beschrijving

Laboratory Procedures, Renal function, Urine, Sampling, Time

Datatype

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

Day -1

1 Formulieren
  1. StudyEvent: ODM
    1. Day -1
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Day -1 (1)
CL Item
Day -1 (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])
Body Temperature, Oral
Item
Temperature - Oral
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
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
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
Abnormal (2)
CL Item
Not Done (2)
Physical Examination, Comment
Item
Comment
text
C0031809 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Drug and Alcohol Screen
C0202274 (UMLS CUI-1)
C0202304 (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, Amphetamines
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, Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0936079 (UMLS CUI [1,2])
Urine drug screening, Cannabis
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, Opiates
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Urine drug screening, Barbiturates
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Item
Alcohol
text
C0202304 (UMLS CUI [1])
Ethanol measurement
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Smokerlyser Breath Test
C2207180 (UMLS CUI-1)
breath test expired carbon monoxide, Sampling, Date in time
Item
Date sample taken
date
C2207180 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Results
text
C2207180 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
breath test expired carbon monoxide, Result
Code List
Results
CL Item
Positive (1)
CL Item
Negative (2)
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
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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