ID

28131

Descrição

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: Cognitive Function Substudy.

Palavras-chave

Versões (5)
  1. 15/09/2017 15/09/2017 -
  2. 21/09/2017 21/09/2017 -
  3. 13/10/2017 13/10/2017 -
  4. 23/10/2017 23/10/2017 -
  5. 20/12/2017 20/12/2017 -
Titular dos direitos

GlaxoSmithKline

Transferido a

20 de dezembro de 2017

DOI

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Licença

Creative Commons BY-NC 3.0
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Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

Inglês

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários  
Cognitive Function Eligibility Question
Descrição

Cognitive Function Eligibility Question

1. Did the subject meet all the Cognitive Function substudy entry criteria?
Descrição

No, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0392335
[I08] Cognitive Function 1. Signed written informed consent prior to beginning substudy-related procedures (subject must understand the aims, investigational procedures and possible consequences of the substudy).
Descrição

Inclusion criterion. Note: Consent to participate in the substudy is separate from consent to participate in the parent study.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
[I09] Cognitive Function 2. Adequate vision and hearing for neuropsychological testing.
Descrição

Inclusion criterion.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042789
UMLS CUI [1,2]
C0018767
[E22] Cognitive Function 1. High level of cognitive function as assessed by a score of >50 on the Symbol Digit Modalities Test.
Descrição

Exclusion criterion.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0392335
[E23] Cognitive Function 2. Significant deficit in verbal intelligence as assessed by Adult Reading Test score <85.
Descrição

Exclusion criterion.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021704
[E24] Cognitive Function 3. Aphasia
Descrição

Exclusion criterion.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003537
[E25] Cognitive Function 4. Inability to perform the test due to significant weakness in dominant hand.
Descrição

Exclusion criterion.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0449722
Cognitive Function substudy
Descrição

Cognitive Function substudy

1. Cognitive function testing completed
Descrição

cognitive function testing completed

Tipo de dados

text

Alias
UMLS CUI [1]
C0392335
1. Date cognitive function testing completed
Descrição

Date cognitive function testing

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0392335
Cognitive function substudy (early withdrawal/follow-up)
Descrição

Cognitive function substudy (early withdrawal/follow-up)

1. Cognitive function testing
Descrição

Cognitive function testing early withdrawal follow-up

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C1522577
Date of cognitive function testing (at Early Withdrawal IP or Follow-up visit)
Descrição

Date cognitive function testing Early Withdrawal Follow-up

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C1522577
UMLS CUI [1,4]
C0011008
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Similar models

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Cognitive Function Eligibility Question
Item
1. Did the subject meet all the Cognitive Function substudy entry criteria?
text
C1516637 (UMLS CUI [1,1])
C0392335 (UMLS CUI [1,2])
Cognitive Function substudy entry criteria met
Code List
1. Did the subject meet all the Cognitive Function substudy entry criteria?
CL Item
Yes (Y)
C1705108 (UMLS CUI-1)
(Comment:en)
CL Item
No, please select all boxes corresponding to violations of any inclusion/exclusion criteria (N)
C0013893 (UMLS CUI-1)
(Comment:en)
Informed consent
Item
[I08] Cognitive Function 1. Signed written informed consent prior to beginning substudy-related procedures (subject must understand the aims, investigational procedures and possible consequences of the substudy).
boolean
C0021430 (UMLS CUI [1])
Vision and hearing
Item
[I09] Cognitive Function 2. Adequate vision and hearing for neuropsychological testing.
boolean
C0042789 (UMLS CUI [1,1])
C0018767 (UMLS CUI [1,2])
High level cognitive function
Item
[E22] Cognitive Function 1. High level of cognitive function as assessed by a score of >50 on the Symbol Digit Modalities Test.
boolean
C0392335 (UMLS CUI [1])
deficit in verbal intelligence
Item
[E23] Cognitive Function 2. Significant deficit in verbal intelligence as assessed by Adult Reading Test score <85.
boolean
C0021704 (UMLS CUI [1])
Aphasia
Item
[E24] Cognitive Function 3. Aphasia
boolean
C0003537 (UMLS CUI [1])
weakness in dominant hand
Item
[E25] Cognitive Function 4. Inability to perform the test due to significant weakness in dominant hand.
boolean
C0449722 (UMLS CUI [1])
Item Group
Cognitive Function substudy
Item
1. Cognitive function testing completed
text
C0392335 (UMLS CUI [1])
cognitive function testing completed
Code List
1. Cognitive function testing completed
CL Item
Date (-99)
CL Item
Not done (ND)
Date cognitive function testing
Item
1. Date cognitive function testing completed
date
C0011008 (UMLS CUI [1,1])
C0392335 (UMLS CUI [1,2])
Item Group
Cognitive function substudy (early withdrawal/follow-up)
Item
1. Cognitive function testing
text
C0392335 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
Cognitive function testing early withdrawal follow-up
Code List
1. Cognitive function testing
CL Item
Previously assessed at Month 24 visit (1)
C1516048 (UMLS CUI-1)
(Comment:en)
CL Item
Testing at Early Withdrawal IP or Follow-up visit (2)
(Comment:en)
CL Item
Not done (Z)
C1272696 (UMLS CUI-1)
(Comment:en)
Date cognitive function testing Early Withdrawal Follow-up
Item
Date of cognitive function testing (at Early Withdrawal IP or Follow-up visit)
date
C0392335 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C1522577 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
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