ID

30360

Beskrivning

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: Visit Documentation 18 Specification: PET SD Day 2

Länk

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

Nyckelord

Versioner (1)
  1. 2018-05-30 2018-05-30 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

30 maj 2018

DOI

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Licens

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

Engelsk

Visit Documentation 18

1 Formulär  
  1. StudyEvent: ODM
    1. Visit Documentation 18
Date and Type of Visit
Beskrivning

Date and Type of Visit

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C3641100
UMLS CUI-3
C0008976
Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Beskrivning

Time of Visit

Datatyp

time

Alias
UMLS CUI [1]
C1320304
Cohort
Beskrivning

Cohort

Datatyp

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Beskrivning

Please choose the type of visit/form you would like to answer, for example Cohort 1-4 SD Day 1

Datatyp

integer

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
ECG
Beskrivning

ECG

Alias
UMLS CUI-1
C1623258
Type of ECG
Beskrivning

Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) PET SD Day 2: 12-lead-ECG, Telemetry (0-6hrs)

Datatyp

integer

Alias
UMLS CUI [1]
C1623258
Start Date ECG
Beskrivning

Start Date ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0808070
Start Time ECG
Beskrivning

Start Time ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1301880
Stop Date ECG
Beskrivning

Stop Date ECG

Datatyp

date

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0806020
Stop Time ECG
Beskrivning

Stop Time ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1522314
Questionnaires
Beskrivning

Questionnaires

Alias
UMLS CUI-1
C0034394
Simpson Angus Scale Score
Beskrivning

Simpson Angus Scale Score

Datatyp

integer

Alias
UMLS CUI [1,1]
C0041755
UMLS CUI [1,2]
C0015371
UMLS CUI [1,3]
C0681889
The Barnes Akathisia Scale Score
Beskrivning

The Barnes Akathisia Scale Score

Datatyp

integer

Alias
UMLS CUI [1]
C3541345
Abnormal Involuntary Movement Scale Score
Beskrivning

Abnormal Involuntary Movement Scale Score

Datatyp

integer

Alias
UMLS CUI [1]
C0450978
Profile of Mood States
Beskrivning

Profile of Mood States

Datatyp

text

Alias
UMLS CUI [1]
C0451394
Columbia Suicide Severity Rating Scale Score
Beskrivning

Columbia Suicide Severity Rating Scale Score

Datatyp

integer

Alias
UMLS CUI [1]
C3888485
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Similar models

Visit Documentation 18

1 Formulär
  1. StudyEvent: ODM
    1. Visit Documentation 18
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date and Type of Visit
C1320303 (UMLS CUI-1)
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
Time of Visit
Item
Time of Visit
time
C1320304 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
Cohort 1 (1)
CL Item
Cohort 2 (2)
CL Item
Cohort 3 (3)
CL Item
Cohort 4 (4)
CL Item
PET (5)
Item
Type of Visit
integer
C3641100 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Type of Visit
Code List
Type of Visit
CL Item
PET SD Day 2 (1)
Item Group
ECG
C1623258 (UMLS CUI-1)
Item
Type of ECG
integer
C1623258 (UMLS CUI [1])
Type of ECG
Code List
Type of ECG
CL Item
12 lead ECG (1)
CL Item
Telemetry ECG (2)
Start Date ECG
Item
Start Date ECG
date
C1623258 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time ECG
Item
Start Time ECG
time
C1623258 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop Date ECG
Item
Stop Date ECG
date
C1623258 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop Time ECG
Item
Stop Time ECG
time
C1623258 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item Group
Questionnaires
C0034394 (UMLS CUI-1)
Simpson Angus Scale Score
Item
Simpson Angus Scale Score
integer
C0041755 (UMLS CUI [1,1])
C0015371 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
The Barnes Akathisia Scale Score
Item
The Barnes Akathisia Scale Score
integer
C3541345 (UMLS CUI [1])
Abnormal Involuntary Movement Scale Score
Item
Abnormal Involuntary Movement Scale Score
integer
C0450978 (UMLS CUI [1])
Profile of Mood States
Item
Profile of Mood States
text
C0451394 (UMLS CUI [1])
Columbia Suicide Severity Rating Scale Score
Item
Columbia Suicide Severity Rating Scale Score
integer
C3888485 (UMLS CUI [1])
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