ID

30153

Description

Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: 12-lead ECG

Link

https://clinicaltrials.gov/ct2/show/NCT01036061

Keywords

Versions (1)
  1. 5/16/18 5/16/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 16, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061

English

12-lead ECG

1 forms  
  1. StudyEvent: ODM
    1. 12-lead ECG
12-lead ECG
Description

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
UMLS CUI-3
C0031809
Start Date of ECG
Description

Start Date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Description

Start Time of ECG

Data type

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • Beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
Method of QTC Measurement
Description

Method of QTC Measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C1299991
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcB
Description

QTcB

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
msec
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcF
Description

QTcF

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0855331
msec
Method of QTC Measurement. If manual, record the RR interval that precedes the measured QT interval
Description

RR interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0489636
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Description

(complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE)

Data type

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
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Similar models

12-lead ECG

1 forms
  1. StudyEvent: ODM
    1. 12-lead ECG
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Method of QTC Measurement
integer
C0489625 (UMLS CUI [1,1])
C1299991 (UMLS CUI [1,2])
Method ofQTC Measurement
Code List
Method of QTC Measurement
CL Item
Machine (1)
CL Item
Manual (2)
QTcB
Item
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcB
float
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
QTcF
Item
Method of QTC Measurement. If machine, record the QTC values(s) generated by the machine: QTcF
float
C1882513 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
RR interval
Item
Method of QTC Measurement. If manual, record the RR interval that precedes the measured QT interval
float
C0489636 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
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)
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