ID

36793

Beschreibung

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

Stichworte

Versionen (2)
  1. 11.06.19 11.06.19 -
  2. 11.06.19 11.06.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

11. Juni 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503

Englisch

Admission - Drug and Alcohol Screen; Vital Signs; 12-Lead ECG

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Drug and Alcohol Screen Admission 1 - Date and Time of Sample taken
Beschreibung

Drug and Alcohol Screen Admission 1 - Date and Time of Sample taken

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
UMLS CUI-3
C1264639
UMLS CUI-4
C0200345
UMLS CUI-5
C0030673
Drug and Alcohol Screeen - Date and Time Sample taken
Beschreibung

Drug and Alcohol Screeen - Date and Time Sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0200345
UMLS CUI [2,1]
C0202304
UMLS CUI [2,2]
C1264639
UMLS CUI [2,3]
C0200345
Drug and Alcohol Screen - Admission 1
Beschreibung

Drug and Alcohol Screen - Admission 1

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
UMLS CUI-3
C0030673
Cocaine
Beschreibung

Cocaine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0009170
Amphetamines
Beschreibung

Amphetamines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0002667
Benzodiazepines
Beschreibung

Benzodiazepines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0005064
Cannabinoids
Beschreibung

Cannabinoids

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0006864
Opiates
Beschreibung

Opiates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0376196
Barbiturates
Beschreibung

Barbiturates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0004745
Alcohol
Beschreibung

Alcohol

Datentyp

integer

Alias
UMLS CUI [1]
C0202304
Drug and Alcohol Screen Admission 2 - Date and Time of Sample taken
Beschreibung

Drug and Alcohol Screen Admission 2 - Date and Time of Sample taken

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
UMLS CUI-3
C1264639
UMLS CUI-4
C0200345
UMLS CUI-5
C0030673
Drug and Alcohol Screeen - Date and Time Sample taken
Beschreibung

Drug and Alcohol Screeen - Date and Time Sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0200345
UMLS CUI [2,1]
C0202304
UMLS CUI [2,2]
C1264639
UMLS CUI [2,3]
C0200345
Drug and Alcohol Screen - Admission 2
Beschreibung

Drug and Alcohol Screen - Admission 2

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
UMLS CUI-3
C0030673
Cocaine
Beschreibung

Cocaine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0009170
Amphetamines
Beschreibung

Amphetamines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0002667
Benzodiazepines
Beschreibung

Benzodiazepines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0005064
Cannabinoids
Beschreibung

Cannabinoids

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0006864
Opiates
Beschreibung

Opiates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0376196
Barbiturates
Beschreibung

Barbiturates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0004745
Alcohol
Beschreibung

Alcohol

Datentyp

integer

Alias
UMLS CUI [1]
C0202304
Drug and Alcohol Screen Admission 3 - Date and Time of Sample taken
Beschreibung

Drug and Alcohol Screen Admission 3 - Date and Time of Sample taken

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
UMLS CUI-3
C1264639
UMLS CUI-4
C0200345
UMLS CUI-5
C0030673
Drug and Alcohol Screeen - Date and Time Sample taken
Beschreibung

Alcohol Screeen - Date and Time Sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1264639
UMLS CUI [1,3]
C0200345
UMLS CUI [2,1]
C0202304
UMLS CUI [2,2]
C1264639
UMLS CUI [2,3]
C0200345
Drug and Alcohol Screen - Admission 3
Beschreibung

Drug and Alcohol Screen - Admission 3

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0202304
UMLS CUI-3
C0030673
Cocaine
Beschreibung

Cocaine

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0009170
Amphetamines
Beschreibung

Amphetamines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0002667
Benzodiazepines
Beschreibung

Benzodiazepines

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0005064
Cannabinoids
Beschreibung

Cannabinoids

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0006864
Opiates
Beschreibung

Opiates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0376196
Barbiturates
Beschreibung

Barbiturates

Datentyp

integer

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0004745
Alcohol
Beschreibung

Alcohol

Datentyp

integer

Alias
UMLS CUI [1]
C0202304
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Vital Signs - Date
Beschreibung

Vital Signs - Date

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time
Beschreibung

Planned Relative Time

Datentyp

text

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

Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood Pressure Semi-supine
Beschreibung

Systolic Blood Pressure Semi-supine

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure Semi-supine
Beschreibung

Diastolic Blood Pressure Semi-supine

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschreibung

ECG Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned relative Time
Beschreibung

Planned relative Time

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
UMLS CUI [1,3]
C1301732
Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
12-Lead ECG - Heart Rate
Beschreibung

12-Lead ECG - Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Beschreibung

QTc Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Beschreibung

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
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Ähnliche Modelle

Admission - Drug and Alcohol Screen; Vital Signs; 12-Lead ECG

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Drug and Alcohol Screen Admission 1 - Date and Time of Sample taken
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0200345 (UMLS CUI-4)
C0030673 (UMLS CUI-5)
Drug and Alcohol Screeen - Date and Time Sample taken
Item
Drug and Alcohol Screeen - Date and Time Sample taken
datetime
C0373483 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0202304 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
Item Group
Drug and Alcohol Screen - Admission 1
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C0030673 (UMLS CUI-3)
Item
Cocaine
integer
C0373483 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
integer
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamines
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
integer
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Cannabinoids
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
integer
C0373483 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Opiates
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
integer
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
Alcohol
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Drug and Alcohol Screen Admission 2 - Date and Time of Sample taken
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0200345 (UMLS CUI-4)
C0030673 (UMLS CUI-5)
Drug and Alcohol Screeen - Date and Time Sample taken
Item
Drug and Alcohol Screeen - Date and Time Sample taken
datetime
C0373483 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0202304 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
Item Group
Drug and Alcohol Screen - Admission 2
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C0030673 (UMLS CUI-3)
Item
Cocaine
integer
C0373483 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine
Code List
Cocaine
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Amphetamines
integer
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamines
Code List
Amphetamines
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Cannabinoids
integer
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Cannabinoids
Code List
Cannabinoids
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Opiates
integer
C0373483 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Opiates
Code List
Opiates
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Barbiturates
integer
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates
Code List
Barbiturates
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
Alcohol
Code List
Alcohol
CL Item
Positive  (1)
CL Item
Negative (2)
Item Group
Drug and Alcohol Screen Admission 3 - Date and Time of Sample taken
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C1264639 (UMLS CUI-3)
C0200345 (UMLS CUI-4)
C0030673 (UMLS CUI-5)
Alcohol Screeen - Date and Time Sample taken
Item
Drug and Alcohol Screeen - Date and Time Sample taken
datetime
C0373483 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0202304 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
Item Group
Drug and Alcohol Screen - Admission 3
C0373483 (UMLS CUI-1)
C0202304 (UMLS CUI-2)
C0030673 (UMLS CUI-3)
Item
Cocaine
integer
C0373483 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine
Code List
Cocaine
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Amphetamines
integer
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamines
Code List
Amphetamines
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Cannabinoids
integer
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Cannabinoids
Code List
Cannabinoids
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Opiates
integer
C0373483 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Opiates
Code List
Opiates
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Barbiturates
integer
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates
Code List
Barbiturates
CL Item
Positive  (1)
CL Item
Negative (2)
Item
Alcohol
integer
C0202304 (UMLS CUI [1])
Alcohol
Code List
Alcohol
CL Item
Positive  (1)
CL Item
Negative (2)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Vital Signs - Date
Item
Vital Signs - Date
date
C2826644 (UMLS CUI [1])
Planned Relative Time
Item
Planned Relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Actual Time
Item
Actual Time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure Semi-supine
Item
Systolic Blood Pressure Semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-supine
Item
Diastolic Blood Pressure Semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
ECG Number
Code List
ECG Number
CL Item
ECG 1 (1)
CL Item
ECG 2 (2)
CL Item
ECG 3 (3)
CL Item
ECG 4 (4)
CL Item
ECG 5 (5)
CL Item
ECG 6 (6)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned relative Time
Item
Planned relative Time
text
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
12-Lead ECG - Heart Rate
Item
12-Lead ECG - Heart Rate
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
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])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
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