ID

28311

Beskrivning

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)

Nyckelord

Versioner (4)
  1. 2017-10-05 2017-10-05 -
  2. 2017-10-16 2017-10-16 -
  3. 2017-10-23 2017-10-23 -
  4. 2018-01-03 2018-01-03 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 januari 2018

DOI

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Licens

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

Engelsk

Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

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

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

1. Was a pharmacokinetic blood sample obtained?
Beskrivning

pharmacokinetic blood sample

Datatyp

boolean

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

Date of blood sample

Datatyp

date

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

Time of blood sample

Datatyp

time

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

date of last investigational product dose prior to PK sample

Datatyp

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
Beskrivning

time of last investigational product dose prior to PK sample

Datatyp

time

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

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

Datatyp

text

Alias
UMLS CUI [1]
C1299222
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Similar models

Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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