ID

29853

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: Logs/Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Link

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

Trefwoorden

Versies (1)
  1. 24-04-18 24-04-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

24 april 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

Logs/Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

1 Formulieren  
Date of Visit
Beschrijving

Date of Visit

Alias
UMLS CUI-1
C1320303
Date of Visit
Beschrijving

Date below is the start of the study for this subject

Datatype

date

Alias
UMLS CUI [1]
C1320303
Logs/Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
Beschrijving

Logs/Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C1522634
UMLS CUI-3
C0877248
UMLS CUI-4
C2347852
Were any concomitant medications taken by the subject during the study?
Beschrijving

concomitant medications

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Did the subject experience any non-serious adverse events during the study?
Beschrijving

non-serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1518404
Did the subject experience any serious adverse events during the study?
Beschrijving

serious adverse events

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
Beschrijving

abnormal ECG measurements

Datatype

boolean

Alias
UMLS CUI [1]
C0522055
Were any repeat haematology or clinical chemistry samples taken?
Beschrijving

Repeat haematology or clinical chemistry samples taken

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0200345
Were any repeat urinalysis samples taken?
Beschrijving

urinalysis samples

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
Were any repeat ECGs performed?
Beschrijving

ECG

Datatype

boolean

Alias
UMLS CUI [1]
C1623258
Were any repeat vital signs recorded?
Beschrijving

vital signs

Datatype

boolean

Alias
UMLS CUI [1]
C0518766
Were any repeat AIMS recorded?
Beschrijving

AIMS

Datatype

boolean

Alias
UMLS CUI [1]
C0450978
Were any repeat BAS recorded?
Beschrijving

BAS

Datatype

boolean

Were any repeat SAS recorded?
Beschrijving

SAS

Datatype

boolean

Alias
UMLS CUI [1]
C0037315
Were any repeat POMSB recorded?
Beschrijving

POMSB

Datatype

boolean

Were any repeat PK blood samples taken?
Beschrijving

blood samples

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
Was any repeat Holter monitoring performed?
Beschrijving

Holter

Datatype

boolean

Alias
UMLS CUI [1]
C0013801
Was any repeat Telemetry performed?
Beschrijving

Telemetry

Datatype

boolean

Alias
UMLS CUI [1]
C0039451
Liver Event
Beschrijving

Liver Event

Alias
UMLS CUI-1
C1556667
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Beschrijving

If liver event occurred, stop investigational product, complete date stopped on Investigational Product form and contact GSK within 24 hours of occurrence of Liver event by phone or fax. NOTE: If the liver event meets the definition of an SAE, the SA!E form must be completed in Inform. lf lnFonn is unavailable, the SAE form should be faxed to GSK. * Obtain tests as per protocol * An unscheduled PK sample must be obtained within < insert time interval recommended by Clinical phannacokinetics representative> of last dose * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to CSK within 24 hours)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
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Similar models

Logs/Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI-1)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Logs/Repeats - Adverse Event/Concomitant Medication/Repeat Assessment Check Questions
C0220825 (UMLS CUI-1)
C1522634 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C2347852 (UMLS CUI-4)
concomitant medications
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
C1518404 (UMLS CUI [1])
serious adverse events
Item
Did the subject experience any serious adverse events during the study?
boolean
C1519255 (UMLS CUI [1])
abnormal ECG measurements
Item
Were any abnormal, clinically significant ECG measurements recorded for this subject during the study?
boolean
C0522055 (UMLS CUI [1])
Repeat haematology or clinical chemistry samples taken
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0008000 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
urinalysis samples
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
ECG
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1])
vital signs
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1])
AIMS
Item
Were any repeat AIMS recorded?
boolean
C0450978 (UMLS CUI [1])
BAS
Item
Were any repeat BAS recorded?
boolean
SAS
Item
Were any repeat SAS recorded?
boolean
C0037315 (UMLS CUI [1])
POMSB
Item
Were any repeat POMSB recorded?
boolean
blood samples
Item
Were any repeat PK blood samples taken?
boolean
C0005834 (UMLS CUI [1])
Holter
Item
Was any repeat Holter monitoring performed?
boolean
C0013801 (UMLS CUI [1])
Telemetry
Item
Was any repeat Telemetry performed?
boolean
C0039451 (UMLS CUI [1])
Item Group
Liver Event
C1556667 (UMLS CUI-1)
liver chemistry results
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
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