ID
36732
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-06-04 2019-06-04 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
4 juni 2019
DOI
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Licens
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
Beskrivning
Pre-MRI Questionnaire
Alias
- UMLS CUI-1
- C0024485
- UMLS CUI-2
- C0034394
Beskrivning
Demography
Alias
- UMLS CUI-1
- C0011298
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Sex
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Check one
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beskrivning
Check all that apply
Datatyp
integer
Alias
- UMLS CUI [1]
- C3841890
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Planned Relative Time
Datatyp
integer
Måttenheter
- min
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1301732
Beskrivning
Actual time
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
Semi-supine systolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0522019
Beskrivning
Semi-supine diastolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0522019
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
ECG Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0237753
Beskrivning
Start Date of ECG
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beskrivning
Planned Relative Time
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1301732
Beskrivning
Start time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beskrivning
Heart Rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR lnterval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
If clinically significant, complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beskrivning
Transcribe from the 12 Lead ECG result page.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0237753
Beskrivning
Date of ECG
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
Time of ECG
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beskrivning
Check all that apply.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0199556
Beskrivning
Rhythm Abnormality Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0947611
Beskrivning
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0429084
- UMLS CUI [3]
- C0429098
Beskrivning
P-Wave and QRS Morphology Abnormality Comment
Datatyp
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
Beskrivning
12-Lead ECG Abnormalities - C. Conduction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0232217
Beskrivning
Conduction Abnormality Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [2]
- C0947611
Beskrivning
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C1331539
- UMLS CUI [3]
- C0948857
Beskrivning
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
- UMLS CUI [3]
- C0947611
Beskrivning
12-Lead ECG Other Abnormalities
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0205394
Beskrivning
12-Lead ECG Other Abnormalities Comment
Datatyp
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
Beskrivning
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beskrivning
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011900
Beskrivning
Medical Conditions - Status
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beskrivning
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Date of Assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
1. Hair and skin
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2,1]
- C0018494
- UMLS CUI [2,2]
- C1123023
Beskrivning
Describe abnormal finding of Hair and Skin
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2,1]
- C0018494
- UMLS CUI [2,2]
- C1123023
- UMLS CUI [3]
- C0678257
Beskrivning
2. Lymph nodes
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0024204
Beskrivning
Describe abnormal finding of Lymph nodes
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0024204
- UMLS CUI [3]
- C0678257
Beskrivning
3. Eyes
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0015392
Beskrivning
Describe abnormal finding of Eyes
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0015392
- UMLS CUI [3]
- C0678257
Beskrivning
4. Ears, Nose and Throat
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278350
Beskrivning
Describe abnormal finding of Ears, Nose and Throat
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278350
- UMLS CUI [3]
- C0678257
Beskrivning
5. Breasts
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199850
Beskrivning
Describe abnormal finding of Breasts
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199850
- UMLS CUI [3]
- C0678257
Beskrivning
6. Respiratory
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0035237
Beskrivning
Describe abnormal finding of Respiratory system
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0035237
- UMLS CUI [3]
- C0678257
Beskrivning
7. Cardiovascular
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0007226
Beskrivning
Describe abnormal finding of Cardiovascular System
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0007226
- UMLS CUI [3]
- C0678257
Beskrivning
8. Abdomen
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0000726
Beskrivning
Describe abnormal finding of Abdomen
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0000726
- UMLS CUI [3]
- C0678257
Beskrivning
9. Urogenital
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C1828035
Beskrivning
Describe abnormal finding of Urogenital System
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C1828035
- UMLS CUI [3]
- C0678257
Beskrivning
10. Pelvic
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0030797
Beskrivning
Describe abnormal finding of Pelvis
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0030797
- UMLS CUI [3]
- C0678257
Beskrivning
11. Rectal
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199900
Beskrivning
Describe abnormal finding of Rectum
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199900
- UMLS CUI [3]
- C0678257
Beskrivning
12. Musculoskeletal
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0026860
Beskrivning
Describe abnormal finding of Musculoskeletal System
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0026860
- UMLS CUI [3]
- C0678257
Beskrivning
13. Neurological
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0027853
Beskrivning
Describe abnormal finding of Neurological Examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0027853
- UMLS CUI [3]
- C0678257
Beskrivning
14. Mental Status
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278060
Beskrivning
Description of abnormal finding of Mental Status
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278060
- UMLS CUI [3]
- C0678257
Beskrivning
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Beskrivning
If Yes, record the average number of units of alcohol consumed per week
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
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.
Datatyp
float
Måttenheter
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beskrivning
Drug and alcohol screen
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C0202304
Beskrivning
Date and time of sample taken
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beskrivning
Cocaine
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0009170
Beskrivning
Amphetamines
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0002667
Beskrivning
Benzodiazepines
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0005064
Beskrivning
Cannabinoids
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0006864
Beskrivning
Opiates
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0376196
Beskrivning
Barbiturates
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0004745
Beskrivning
Alcohol
Datatyp
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])
C0808070 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1704258 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
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])