ID

28401

Beschrijving

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Pharmacokinetics (Liver PK)

Trefwoorden

Versies (5)
  1. 11-10-17 11-10-17 -
  2. 16-10-17 16-10-17 -
  3. 16-10-17 16-10-17 -
  4. 23-10-17 23-10-17 -
  5. 11-01-18 11-01-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 januari 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

Engels

Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
An unscheduled PK blood sample must be obtained within 72 hours of last dose.
Beschrijving

An unscheduled PK blood sample must be obtained within 72 hours of last dose.

1. Was a pharmacokinetic blood sample obtained?
Beschrijving

pharmacokinetic blood sample

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0178913
If yes, date sample taken
Beschrijving

date blood sample taken

Datatype

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
If yes, time sample taken
Beschrijving

time blood sample taken

Datatype

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
If Yes, date of last investigational product dose prior to PK sample
Beschrijving

date last investigational product dose prior to PK sample

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0678766
If Yes, time of last investigational product dose prior to PK sample
Beschrijving

time last investigational product dose prior to PK sample

Datatype

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0678766
Sample Identifier/Sample Number
Beschrijving

Sample Identifier and Sample Number are conditional. The study team must choose one for inclusion on the eCRF form.

Datatype

integer

Alias
UMLS CUI [1]
C1299222
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Similar models

Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
An unscheduled PK blood sample must be obtained within 72 hours of last dose.
pharmacokinetic blood sample
Item
1. Was a pharmacokinetic blood sample obtained?
boolean
C0031328 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
date blood sample taken
Item
If yes, date sample taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
time blood sample taken
Item
If yes, time sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
date last investigational product dose prior to PK sample
Item
If Yes, date of last investigational product dose prior to PK sample
date
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
time last investigational product dose prior to PK sample
Item
If Yes, time of last investigational product dose prior to PK sample
time
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
Sample Identifier/Sample Number
Item
Sample Identifier/Sample Number
integer
C1299222 (UMLS CUI [1])
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