ID

30344

Beschrijving

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 11 Specification: Cohort 1-4 RD Day-8

Link

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

Trefwoorden

Versies (1)
  1. 29-05-18 29-05-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 mei 2018

DOI

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Licentie

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

Engels

Visit Documentation 11

1 Formulieren  
  1. StudyEvent: ODM
    1. Visit Documentation 11
Date and Type of Visit
Beschrijving

Date and Type of Visit

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

Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschrijving

Patient

Datatype

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschrijving

Patient Number

Datatype

text

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

Date of Visit/Assessment

Datatype

date

Alias
UMLS CUI [1]
C1320303
Time of Visit
Beschrijving

Time of Visit

Datatype

time

Alias
UMLS CUI [1]
C1320304
Cohort
Beschrijving

Cohort

Datatype

integer

Alias
UMLS CUI [1]
C0599755
Type of Visit
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
Questionnaires
Beschrijving

Questionnaires

Alias
UMLS CUI-1
C0034394
Columbia Suicide Severity Rating Scale Score
Beschrijving

Columbia Suicide Severity Rating Scale Score

Datatype

integer

Alias
UMLS CUI [1]
C3888485
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Date of dose
Beschrijving

Date of dose

Datatype

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
Time of dose
Beschrijving

Time of dose

Datatype

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Pharmacokinetics Blood
Beschrijving

Pharmacokinetics Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Time from last dose of investigational product until Clinical Chemistry measurement
Beschrijving

Time from last dose of investigational product until Clinical Chemistry measurement

Datatype

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
Actual Time of Pharmacokinetics Blood
Beschrijving

Actual Time of Pharmacokinetics Blood

Datatype

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0040223
Terug naar het begin van de pagina

Similar models

Visit Documentation 11

1 Formulieren
  1. StudyEvent: ODM
    1. Visit Documentation 11
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Cohort 1-4 RD Day 8 (1)
Item Group
Questionnaires
C0034394 (UMLS CUI-1)
Columbia Suicide Severity Rating Scale Score
Item
Columbia Suicide Severity Rating Scale Score
integer
C3888485 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Date of dose
Item
Date of dose
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Time of dose
Item
Time of dose
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pharmacokinetics Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Time from last dose of investigational product until Clinical Chemistry measurement
integer
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
Timepoint of Laboratory Procedure
Code List
Time from last dose of investigational product until Clinical Chemistry measurement
CL Item
Predose (1)
Actual Time of Pharmacokinetics Blood
Item
Actual Time of Pharmacokinetics Blood
time
C0031328 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

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