ID

28131

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: Cognitive Function Substudy.

Nyckelord

Versioner (5)
  1. 2017-09-15 2017-09-15 -
  2. 2017-09-21 2017-09-21 -
  3. 2017-10-13 2017-10-13 -
  4. 2017-10-23 2017-10-23 -
  5. 2017-12-20 2017-12-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 december 2017

DOI

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Licens

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

Engelsk

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär  
Cognitive Function Eligibility Question
Beskrivning

Cognitive Function Eligibility Question

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

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

Datatyp

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).
Beskrivning

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

Datatyp

boolean

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

Inclusion criterion.

Datatyp

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.
Beskrivning

Exclusion criterion.

Datatyp

boolean

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

Exclusion criterion.

Datatyp

boolean

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

Exclusion criterion.

Datatyp

boolean

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

Exclusion criterion.

Datatyp

boolean

Alias
UMLS CUI [1]
C0449722
Cognitive Function substudy
Beskrivning

Cognitive Function substudy

1. Cognitive function testing completed
Beskrivning

cognitive function testing completed

Datatyp

text

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

Date cognitive function testing

Datatyp

date

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

Cognitive function substudy (early withdrawal/follow-up)

1. Cognitive function testing
Beskrivning

Cognitive function testing early withdrawal follow-up

Datatyp

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)
Beskrivning

Date cognitive function testing Early Withdrawal Follow-up

Datatyp

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

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