ID

28311

Description

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 - Repeating form (Scheduled visits)

Keywords

Versions (4)
  1. 10/5/17 10/5/17 -
  2. 10/16/17 10/16/17 -
  3. 10/23/17 10/23/17 -
  4. 1/3/18 1/3/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 3, 2018

DOI

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License

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

English

Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
An unscheduled PK blood sample must be obtained within 72 hours of last dose
Description

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

1. Was a pharmacokinetic blood sample obtained?
Description

pharmacokinetic blood sample

Data type

boolean

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

Date of blood sample

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
If yes, time taken
Description

Time of blood sample

Data type

time

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0040223
If Yes, date of last investigational product dose prior to PK sample
Description

date of last investigational product dose prior to PK sample

Data type

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
Description

time of last investigational product dose prior to PK sample

Data type

time

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

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

Data type

text

Alias
UMLS CUI [1]
C1299222
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Similar models

Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 of blood sample
Item
If yes, date taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of blood sample
Item
If yes, time taken
time
C0200345 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
date of 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 of 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
text
C1299222 (UMLS CUI [1])
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