ID
36732
Description
Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia
Keywords
Versions (1)
- 6/4/19 6/4/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
June 4, 2019
DOI
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License
Creative Commons BY-NC 3.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT NCT00945503
Screening - Pre-MRI Questionnaire; Demography; Vital Signs; 12-Lead ECG; 12-Lead ECG Abnormalities; Medical Conditions; Physical Examination; Alcohol Intake; Drug and Alcohol Screen
Description
Pre-MRI Questionnaire
Alias
- UMLS CUI-1
- C0024485
- UMLS CUI-2
- C0034394
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Check one
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Check all that apply
Data type
integer
Alias
- UMLS CUI [1]
- C3841890
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Body Mass Index
Data type
float
Measurement units
- kg/ m^2
Alias
- UMLS CUI [1]
- C1305855
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Planned Relative Time
Data type
integer
Measurement units
- min
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1301732
Description
Actual time
Data type
time
Alias
- UMLS CUI [1]
- C0040223
Description
Semi-supine systolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0522019
Description
Semi-supine diastolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0522019
Description
Heart Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
ECG Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0237753
Description
Start Date of ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Description
Planned Relative Time
Data type
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1301732
Description
Start time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
Heart Rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR lnterval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTc Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489625
Description
If clinically significant, complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
Transcribe from the 12 Lead ECG result page.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0237753
Description
Date of ECG
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
Time of ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
Check all that apply.
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0199556
Description
Rhythm Abnormality Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0947611
Description
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0429084
- UMLS CUI [3]
- C0429098
Description
P-Wave and QRS Morphology Abnormality Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0429084
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2,1]
- C0429098
- UMLS CUI [2,2]
- C1704258
- UMLS CUI [3]
- C0947611
Description
12-Lead ECG Abnormalities - C. Conduction
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0232217
Description
Conduction Abnormality Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [2]
- C0947611
Description
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C1331539
- UMLS CUI [3]
- C0948857
Description
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
- UMLS CUI [3]
- C0947611
Description
12-Lead ECG Other Abnormalities
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0205394
Description
12-Lead ECG Other Abnormalities Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0947611
Description
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Description
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011900
Description
Medical Conditions - Status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Description
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Description
Date of Assessment
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
1. Hair and skin
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2,1]
- C0018494
- UMLS CUI [2,2]
- C1123023
Description
Describe abnormal finding of Hair and Skin
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2,1]
- C0018494
- UMLS CUI [2,2]
- C1123023
- UMLS CUI [3]
- C0678257
Description
2. Lymph nodes
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0024204
Description
Describe abnormal finding of Lymph nodes
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0024204
- UMLS CUI [3]
- C0678257
Description
3. Eyes
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0015392
Description
Describe abnormal finding of Eyes
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0015392
- UMLS CUI [3]
- C0678257
Description
4. Ears, Nose and Throat
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278350
Description
Describe abnormal finding of Ears, Nose and Throat
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278350
- UMLS CUI [3]
- C0678257
Description
5. Breasts
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199850
Description
Describe abnormal finding of Breasts
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199850
- UMLS CUI [3]
- C0678257
Description
6. Respiratory
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0035237
Description
Describe abnormal finding of Respiratory system
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0035237
- UMLS CUI [3]
- C0678257
Description
7. Cardiovascular
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0007226
Description
Describe abnormal finding of Cardiovascular System
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0007226
- UMLS CUI [3]
- C0678257
Description
8. Abdomen
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0000726
Description
Describe abnormal finding of Abdomen
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0000726
- UMLS CUI [3]
- C0678257
Description
9. Urogenital
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C1828035
Description
Describe abnormal finding of Urogenital System
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C1828035
- UMLS CUI [3]
- C0678257
Description
10. Pelvic
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0030797
Description
Describe abnormal finding of Pelvis
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0030797
- UMLS CUI [3]
- C0678257
Description
11. Rectal
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199900
Description
Describe abnormal finding of Rectum
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199900
- UMLS CUI [3]
- C0678257
Description
12. Musculoskeletal
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0026860
Description
Describe abnormal finding of Musculoskeletal System
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0026860
- UMLS CUI [3]
- C0678257
Description
13. Neurological
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0027853
Description
Describe abnormal finding of Neurological Examination
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0027853
- UMLS CUI [3]
- C0678257
Description
14. Mental Status
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278060
Description
Description of abnormal finding of Mental Status
Data type
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278060
- UMLS CUI [3]
- C0678257
Description
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Description
If Yes, record the average number of units of alcohol consumed per week
Data type
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
1 unit of alcohol in UK = half-pint (220mL) of beer or 1 (25mL) measure of spirits or 1 glass (125mL) of wine. Note: History of regular alcohol consumption within 6 months of the study is defined as: An average weekly intake of greater than 21 units or an average daly intake of greater than 3 units.
Data type
float
Measurement units
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Description
Drug and alcohol screen
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C0202304
Description
Date and time of sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Cocaine
Data type
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0009170
Description
Amphetamines
Data type
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0002667
Description
Benzodiazepines
Data type
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0005064
Description
Cannabinoids
Data type
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0006864
Description
Opiates
Data type
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0376196
Description
Barbiturates
Data type
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0004745
Description
Alcohol
Data type
integer
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0202306
Similar models
Screening - Pre-MRI Questionnaire; Demography; Vital Signs; 12-Lead ECG; 12-Lead ECG Abnormalities; Medical Conditions; Physical Examination; Alcohol Intake; Drug and Alcohol Screen
C0020155 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
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C0199556 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,2])
C0429084 (UMLS CUI [2])
C0429098 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0429098 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2])
C0948857 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
C0011900 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0678257 (UMLS CUI [3])
C0024204 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0015392 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0278350 (UMLS CUI [2])
C0278350 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0199850 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0035237 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0007226 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0000726 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C1828035 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0030797 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0199900 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0026860 (UMLS CUI [2])
C0026860 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0027853 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0278060 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0560579 (UMLS CUI [1,2])
C0202304 (UMLS CUI-2)
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])