Informations:
Erreur:
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
Mots-clés
Versions (1)
- 04/06/2019 04/06/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
4 juin 2019
DOI
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Licence
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
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
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
C0020155 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Has a pre-MRI questionnaire been carried out?
Item
Has a pre-MRI questionnaire been carried out?
boolean
C0024485 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0034394 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
CL Item
African American/ African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/ South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/ North African Heritage (18)
CL Item
White - White/ Caucasian/ European Heritage (19)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Body Mass Index
float
C1305855 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Planned Relative Time
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Semi-supine systolic blood pressure
Item
Semi-supine systolic blood pressure
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Semi-supine diastolic blood pressure
Item
Semi-supine diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
C0522019 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
ECG Number
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Planned Relative Time
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
Start time of ECG
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR lnterval
Item
PR lnterval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
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
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
ECG Number
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Item
12-Lead ECG Abnormalities - A. Rhythm
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
CL Item
Sinus bradycardia (A1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (A21)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (A22)
CL Item
Sinus bradycardia (heart rate < 30 beats/min) (A23)
CL Item
Sinus pause (A3)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (A2)
CL Item
Ectopic supraventricular beats (A4)
CL Item
Ectopic supraventricular rhythm (A20)
CL Item
Wandering atrial pacemaker (A17)
CL Item
Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (A6)
CL Item
Atrial flutter (A7)
CL Item
Atrial fibrillation (A8)
CL Item
Junctional rhythm (heart rate >= 100 beatslmin) (A5)
CL Item
Junctiona| rhythm (A25)
CL Item
Junctional tachycardia (heart rate > 100 beats/min) (A24)
CL Item
Ectopic ventricular beats (A9)
CL Item
Ventricular couplets (A12)
CL Item
Bigeminy (A13)
CL Item
Trigeminy (A28)
CL Item
Electrical alternans (A14)
CL Item
R on T phenomenon (A29)
CL Item
Ventricular fibrillation (A18)
CL Item
ldioventricular rhythm (heart rate < 100 beats/min) (A19)
CL Item
Sustained ventricular tachycardia (A10)
CL Item
Non-sustained ventricular tachycardia (A11)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (A32)
CL Item
Ventricular tachycardia (A27)
CL Item
Monomorphic ventricular tachycardia (A30)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
CL Item
Artificial pacemaker (A16)
CL Item
Other abnormal rhythm (A99)
Rhythm Abnormality Comment
Item
Rhythm Abnormality Comment
text
C1704258 (UMLS CUI [1,1])
C0199556 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0199556 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Item
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0429084 (UMLS CUI [2])
C0429098 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0429084 (UMLS CUI [2])
C0429098 (UMLS CUI [3])
Code List
12-Lead ECG Abnormalities - B. P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (B1)
CL Item
Right atrial abnormality (P pulmonale) (B2)
CL Item
Right ventricular hypertrophy (B3)
CL Item
lntraatrial conduction delay (B5)
CL Item
Increased voltage consistent with left ventricular hypertrophy (D14)
CL Item
Other morphology (B99)
P-Wave and QRS Morphology Abnormality Comment
Item
P-Wave and QRS Morphology Abnormality Comment
text
C0429084 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0429098 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0429098 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
Item
12-Lead ECG Abnormalities - C. Conduction
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
CL Item
First degree AV block (PR interval > 200 msec) (C1)
CL Item
Short PR interval (C20)
CL Item
Second degree AV block (Mobitz type 1) (C2)
CL Item
Second degree AV block (Mobitz type 2) (C3)
CL Item
2:1 AV block (C16)
CL Item
Third degree AV block (C4)
CL Item
Left axis deviation (QRS axis more negative than -30°) (C5)
CL Item
Right axis deviation (QRS axis more positive than +110°) (C6)
CL Item
Incomplete right bundle branch block (C7)
CL Item
Incomplete left bundle branch block (C13)
CL Item
Right bundle branch block (C8)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
CL Item
Left bundle branch block (C9)
CL Item
Bifascicular block (C17)
CL Item
Non-specific intraventricular conduction delay (QRS >= 120 msec) (C10)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
CL Item
Prolonged OT interval (C19)
CL Item
QT/ QTc prolongation >= 500 msec (C12)
CL Item
AV dissociation (C18)
CL Item
Other conduction (C99)
Conduction Abnormality Comment
Item
Conduction Abnormality Comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Item
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2])
C0948857 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2])
C0948857 (UMLS CUI [3])
Code List
12-Lead ECG Abnormalities - D. Depolarisation/ Repolarisation (QRS-T)
CL Item
Non-specific ST-T changes (D7)
CL Item
J point elevation (D19)
CL Item
ST elevation (D8)
CL Item
ST elevation-pericarditis (D21)
CL Item
ST depression (D9)
CL Item
ST segment abnormality, not specified (D96)
CL Item
U waves abnormal (D10)
CL Item
T wave inversion (D11)
CL Item
T wave peaked (D12)
CL Item
T waves flat (D15)
CL Item
T waves biphasic (D16)
CL Item
Notched T-waves (D18)
CL Item
Low QRS voltage (D13)
CL Item
T-wave flattening/ inversion (D17)
CL Item
T wave abnormality, not specified (D97)
CL Item
Other depolarisation/ repolarisation (D99)
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
Item
Depolarisation/ Repolarisation (QRS-T) Abnormality Comment
text
C1331539 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Item
12-Lead ECG Other Abnormalities
text
C0430456 (UMLS CUI [1,1])
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])
CL Item
Other abnormalities (E99)
12-Lead ECG Other Abnormalities Comment
Item
12-Lead ECG Other Abnormalities Comment
text
C0430456 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
Medical Conditions - Diagnosis
Item
Medical Conditions - Diagnosis
text
C0012634 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
Item
Medical Conditions - Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
1. Hair and skin
integer
C0031809 (UMLS CUI [1])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Hair and Skin
Item
Describe abnormal finding of Hair and Skin
text
C0031809 (UMLS CUI [1])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0678257 (UMLS CUI [3])
C0018494 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Lymph nodes
Item
Describe abnormal finding of Lymph nodes
text
C0031809 (UMLS CUI [1])
C0024204 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0024204 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Eyes
Item
Describe abnormal finding of Eyes
text
C0031809 (UMLS CUI [1])
C0015392 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0015392 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
4. Ears, Nose and Throat
integer
C0031809 (UMLS CUI [1])
C0278350 (UMLS CUI [2])
C0278350 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Ears, Nose and Throat
Item
Describe abnormal finding of Ears, Nose and Throat
text
C0031809 (UMLS CUI [1])
C0278350 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0278350 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Breasts
Item
Describe abnormal finding of Breasts
text
C0031809 (UMLS CUI [1])
C0199850 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0199850 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Respiratory system
Item
Describe abnormal finding of Respiratory system
text
C0031809 (UMLS CUI [1])
C0035237 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0035237 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Cardiovascular System
Item
Describe abnormal finding of Cardiovascular System
text
C0031809 (UMLS CUI [1])
C0007226 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0007226 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Abdomen
Item
Describe abnormal finding of Abdomen
text
C0031809 (UMLS CUI [1])
C0000726 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0000726 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Urogenital System
Item
Describe abnormal finding of Urogenital System
text
C0031809 (UMLS CUI [1])
C1828035 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C1828035 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Pelvis
Item
Describe abnormal finding of Pelvis
text
C0031809 (UMLS CUI [1])
C0030797 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0030797 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Not Done (3)
Describe abnormal finding of Rectum
Item
Describe abnormal finding of Rectum
text
C0031809 (UMLS CUI [1])
C0199900 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0199900 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Item
12. Musculoskeletal
integer
C0031809 (UMLS CUI [1])
C0026860 (UMLS CUI [2])
C0026860 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Musculoskeletal System
Item
Describe abnormal finding of Musculoskeletal System
text
C0031809 (UMLS CUI [1])
C0026860 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0026860 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Describe abnormal finding of Neurological Examination
Item
Describe abnormal finding of Neurological Examination
text
C0031809 (UMLS CUI [1])
C0027853 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0027853 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
CL Item
Normal (1)
CL Item
Abnormal (2)
Description of abnormal finding of Mental Status
Item
Description of abnormal finding of Mental Status
text
C0031809 (UMLS CUI [1])
C0278060 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
C0278060 (UMLS CUI [2])
C0678257 (UMLS CUI [3])
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Units of alcohol per week
Item
Units of alcohol per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C0560579 (UMLS CUI [1,2])
Item Group
Drug and alcohol screen
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C0202304 (UMLS CUI-2)
Date and time of sample taken
Item
Date and time of sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Positive (1)
CL Item
Negative (2)