ID

25733

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: Cognitive Function Substudy.

Keywords

Versions (5)
  1. 9/15/17 9/15/17 -
  2. 9/21/17 9/21/17 -
  3. 10/13/17 10/13/17 -
  4. 10/23/17 10/23/17 -
  5. 12/20/17 12/20/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 15, 2017

DOI

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License

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

English

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Cognitive Function Eligibility Question
Description

Cognitive Function Eligibility Question

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

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

Data type

text

[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).
Description

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

Data type

boolean

[I09] Cognitive Function 2. Adequate vision and hearing for neuropsychological testing.
Description

Inclusion criterion.

Data type

boolean

[E22] Cognitive Function 1. High level of cognitive function as assessed by a score of >50 on the Symbol Digit Modalities Test.
Description

Exclusion criterion.

Data type

boolean

[E23] Cognitive Function 2. Significant deficit in verbal intelligence as assessed by Adult Reading Test score <85.
Description

Exclusion criterion.

Data type

boolean

[E24] Cognitive Function 3. Aphasia
Description

Exclusion criterion.

Data type

boolean

[E25] Cognitive Function 4. Inability to perform the test due to significant weakness in dominant hand.
Description

Exclusion criterion.

Data type

boolean

Cognitive Function substudy
Description

Cognitive Function substudy

1. Cognitive function testing completed
Description

cognitive function testing completed

Data type

text

1. Date cognitive function testing completed
Description

Date cognitive function testing

Data type

date

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Similar models

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Cognitive Function Eligibility Question
Item
1. Did the subject meet all the Cognitive Function substudy entry criteria?
text
Cognitive Function substudy entry criteria met
Code List
1. Did the subject meet all the Cognitive Function substudy entry criteria?
CL Item
Yes (Y)
CL Item
No, please select all boxes corresponding to violations of any inclusion/exclusion criteria (N)
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
Vision and hearing
Item
[I09] Cognitive Function 2. Adequate vision and hearing for neuropsychological testing.
boolean
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
deficit in verbal intelligence
Item
[E23] Cognitive Function 2. Significant deficit in verbal intelligence as assessed by Adult Reading Test score <85.
boolean
Aphasia
Item
[E24] Cognitive Function 3. Aphasia
boolean
weakness in dominant hand
Item
[E25] Cognitive Function 4. Inability to perform the test due to significant weakness in dominant hand.
boolean
Item Group
Cognitive Function substudy
Item
1. Cognitive function testing completed
text
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
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