ID

28153

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: Unscheduled visit

Trefwoorden

  1. 21/09/17 21/09/17 -
  2. 23/10/17 23/10/17 -
  3. 22/12/17 22/12/17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

22 dicembre 2017

DOI

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Licentie

Creative Commons BY-NC 3.0

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Unscheduled visit GSK study Chronic Coronary Heart Disease NCT00799903

Unscheduled visit GSK study Chronic Coronary Heart Disease NCT00799903

Status of visit
Beschrijving

Status of visit

1. Which assessments were performed at this unscheduled visit?
Beschrijving

PK sample collection performed at GSK request for sentinel event

Datatype

integer

Alias
UMLS CUI [1]
C0220825
PK sample collection performed at GSK request for sentinel event
Beschrijving

PK sample collection performed at GSK request for sentinel event

1. Was a pharmacokinetic blood sample obtained?
Beschrijving

pharmacokinetic blood sample obtained

Datatype

boolean

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

date sample taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
if yes, time sample taken
Beschrijving

time sample taken

Datatype

time

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

date of last investigational product dose

Datatype

date

Alias
UMLS CUI [1]
C1762893
If Yes, time of last investigational product dose prior to PK sample
Beschrijving

time of last investigational product dose

Datatype

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0678766
UMLS CUI [1,3]
C0011008
Sample Identifier/Sample Number
Beschrijving

Sample Identifier/Sample Number

Datatype

text

Alias
UMLS CUI [1]
C1299222

Similar models

Unscheduled visit GSK study Chronic Coronary Heart Disease NCT00799903

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Status of visit
Item
1. Which assessments were performed at this unscheduled visit?
integer
C0220825 (UMLS CUI [1])
Code List
1. Which assessments were performed at this unscheduled visit?
CL Item
Vital signs (1)
C0518766 (UMLS CUI-1)
(Comment:en)
CL Item
ECG (2)
C1623258 (UMLS CUI-1)
(Comment:en)
CL Item
Lab - blood sample (3)
C0005834 (UMLS CUI-1)
(Comment:en)
CL Item
Urine dipstick (4)
C0430370 (UMLS CUI-1)
(Comment:en)
CL Item
PK (5)
C0022877 (UMLS CUI-1)
(Comment:en)
Item Group
PK sample collection performed at GSK request for sentinel event
pharmacokinetic blood sample obtained
Item
1. Was a pharmacokinetic blood sample obtained?
boolean
C0031328 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
date sample taken
Item
If yes, date sample taken
date
C1302413 (UMLS CUI [1])
time sample taken
Item
if yes, time sample taken
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
date of last investigational product dose
Item
If Yes, date of last investigational product dose prior to PK sample
date
C1762893 (UMLS CUI [1])
time of last investigational product dose
Item
If Yes, time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C0678766 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Sample Identifier/Sample Number
Item
Sample Identifier/Sample Number
text
C1299222 (UMLS CUI [1])

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