ID

28411

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: Child-bearing potential

Keywords

  1. 10/9/17 10/9/17 -
  2. 10/13/17 10/13/17 -
  3. 10/23/17 10/23/17 -
  4. 1/11/18 1/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Child-bearing potential GSK study Chronic Coronary Heart Disease NCT00799903

Child-bearing potential GSK study Chronic Coronary Heart Disease NCT00799903

Child-bearing potential
Description

Child-bearing potential

1. Has child-bearing potential changed?
Description

Change of child-bearing potential

Data type

boolean

Alias
UMLS CUI [1]
C1960468
If child-bearing potential has changed, select one
Description

Change of child-bearing potential reason

Data type

integer

Alias
UMLS CUI [1]
C1960468
If post-menopausal, date of final menses:
Description

date of final menses

Data type

date

Alias
UMLS CUI [1]
C0425932
If sterile, date became sterile:
Description

date became sterile

Data type

date

Alias
UMLS CUI [1,1]
C0021359
UMLS CUI [1,2]
C0011008
Pregnancy information
Description

Pregnancy information

1. Did the subject become pregnant during the study?
Description

pregnancy during study

Data type

boolean

Alias
UMLS CUI [1]
C0549206

Similar models

Child-bearing potential GSK study Chronic Coronary Heart Disease NCT00799903

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Child-bearing potential
Change of child-bearing potential
Item
1. Has child-bearing potential changed?
boolean
C1960468 (UMLS CUI [1])
Item
If child-bearing potential has changed, select one
integer
C1960468 (UMLS CUI [1])
Code List
If child-bearing potential has changed, select one
CL Item
Post-menopausal (2)
C0232970 (UMLS CUI-1)
(Comment:en)
CL Item
Sterile (of child-bearing age) (3)
C0021359 (UMLS CUI-1)
(Comment:en)
date of final menses
Item
If post-menopausal, date of final menses:
date
C0425932 (UMLS CUI [1])
date became sterile
Item
If sterile, date became sterile:
date
C0021359 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Pregnancy information
pregnancy during study
Item
1. Did the subject become pregnant during the study?
boolean
C0549206 (UMLS CUI [1])

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