ID
36732
Beschrijving
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
Trefwoorden
Versies (1)
- 04-06-19 04-06-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 juni 2019
DOI
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Licentie
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
Beschrijving
Pre-MRI Questionnaire
Alias
- UMLS CUI-1
- C0024485
- UMLS CUI-2
- C0034394
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Check one
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Check all that apply
Datatype
integer
Alias
- UMLS CUI [1]
- C3841890
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Planned Relative Time
Datatype
integer
Maateenheden
- min
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1301732
Beschrijving
Actual time
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Semi-supine systolic blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0522019
Beschrijving
Semi-supine diastolic blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0522019
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
ECG Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0237753
Beschrijving
Start Date of ECG
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschrijving
Planned Relative Time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C1301732
Beschrijving
Start time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR lnterval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
If clinically significant, complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschrijving
Transcribe from the 12 Lead ECG result page.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0237753
Beschrijving
Date of ECG
Datatype
date
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
Time of ECG
Datatype
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschrijving
Check all that apply.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0199556
Beschrijving
Rhythm Abnormality Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0199556
- UMLS CUI [1,3]
- C0947611
Beschrijving
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0429084
- UMLS CUI [3]
- C0429098
Beschrijving
P-Wave and QRS Morphology Abnormality Comment
Datatype
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
Beschrijving
12-Lead ECG Abnormalities - C. Conduction
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0232217
Beschrijving
Conduction Abnormality Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0232217
- UMLS CUI [2]
- C0947611
Beschrijving
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C1331539
- UMLS CUI [3]
- C0948857
Beschrijving
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0948857
- UMLS CUI [3]
- C0947611
Beschrijving
12-Lead ECG Other Abnormalities
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0205394
Beschrijving
12-Lead ECG Other Abnormalities Comment
Datatype
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
Beschrijving
Medical Conditions
Alias
- UMLS CUI-1
- C0012634
Beschrijving
Only in the absence of a diagnosis, record the signs and symptoms on separate lines
Datatype
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011900
Beschrijving
Medical Conditions - Status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
1. Hair and skin
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2,1]
- C0018494
- UMLS CUI [2,2]
- C1123023
Beschrijving
Describe abnormal finding of Hair and Skin
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2,1]
- C0018494
- UMLS CUI [2,2]
- C1123023
- UMLS CUI [3]
- C0678257
Beschrijving
2. Lymph nodes
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0024204
Beschrijving
Describe abnormal finding of Lymph nodes
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0024204
- UMLS CUI [3]
- C0678257
Beschrijving
3. Eyes
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0015392
Beschrijving
Describe abnormal finding of Eyes
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0015392
- UMLS CUI [3]
- C0678257
Beschrijving
4. Ears, Nose and Throat
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278350
Beschrijving
Describe abnormal finding of Ears, Nose and Throat
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278350
- UMLS CUI [3]
- C0678257
Beschrijving
5. Breasts
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199850
Beschrijving
Describe abnormal finding of Breasts
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199850
- UMLS CUI [3]
- C0678257
Beschrijving
6. Respiratory
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0035237
Beschrijving
Describe abnormal finding of Respiratory system
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0035237
- UMLS CUI [3]
- C0678257
Beschrijving
7. Cardiovascular
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0007226
Beschrijving
Describe abnormal finding of Cardiovascular System
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0007226
- UMLS CUI [3]
- C0678257
Beschrijving
8. Abdomen
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0000726
Beschrijving
Describe abnormal finding of Abdomen
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0000726
- UMLS CUI [3]
- C0678257
Beschrijving
9. Urogenital
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C1828035
Beschrijving
Describe abnormal finding of Urogenital System
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C1828035
- UMLS CUI [3]
- C0678257
Beschrijving
10. Pelvic
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0030797
Beschrijving
Describe abnormal finding of Pelvis
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0030797
- UMLS CUI [3]
- C0678257
Beschrijving
11. Rectal
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199900
Beschrijving
Describe abnormal finding of Rectum
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0199900
- UMLS CUI [3]
- C0678257
Beschrijving
12. Musculoskeletal
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0026860
Beschrijving
Describe abnormal finding of Musculoskeletal System
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0026860
- UMLS CUI [3]
- C0678257
Beschrijving
13. Neurological
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0027853
Beschrijving
Describe abnormal finding of Neurological Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0027853
- UMLS CUI [3]
- C0678257
Beschrijving
14. Mental Status
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278060
Beschrijving
Description of abnormal finding of Mental Status
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
- UMLS CUI [2]
- C0278060
- UMLS CUI [3]
- C0678257
Beschrijving
Alcohol intake
Alias
- UMLS CUI-1
- C0001948
Beschrijving
If Yes, record the average number of units of alcohol consumed per week
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
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.
Datatype
float
Maateenheden
- units per week
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0560579
Beschrijving
Drug and alcohol screen
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C0202304
Beschrijving
Date and time of sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschrijving
Cocaine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0009170
Beschrijving
Amphetamines
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0002667
Beschrijving
Benzodiazepines
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0005064
Beschrijving
Cannabinoids
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0006864
Beschrijving
Opiates
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0376196
Beschrijving
Barbiturates
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C0004745
Beschrijving
Alcohol
Datatype
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])