ID

28131

Descripción

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.

Palabras clave

Versiones (5)
  1. 15/9/17 15/9/17 -
  2. 21/9/17 21/9/17 -
  3. 13/10/17 13/10/17 -
  4. 23/10/17 23/10/17 -
  5. 20/12/17 20/12/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de diciembre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

Sin comentarios

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

Inglés

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios  
Cognitive Function Eligibility Question
Descripción

Cognitive Function Eligibility Question

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

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

Tipo de datos

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).
Descripción

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

Tipo de datos

boolean

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

Inclusion criterion.

Tipo de datos

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.
Descripción

Exclusion criterion.

Tipo de datos

boolean

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

Exclusion criterion.

Tipo de datos

boolean

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

Exclusion criterion.

Tipo de datos

boolean

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

Exclusion criterion.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0449722
Cognitive Function substudy
Descripción

Cognitive Function substudy

1. Cognitive function testing completed
Descripción

cognitive function testing completed

Tipo de datos

text

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

Date cognitive function testing

Tipo de datos

date

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

Cognitive function substudy (early withdrawal/follow-up)

1. Cognitive function testing
Descripción

Cognitive function testing early withdrawal follow-up

Tipo de datos

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)
Descripción

Date cognitive function testing Early Withdrawal Follow-up

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0392335
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C1522577
UMLS CUI [1,4]
C0011008
Volver a la parte superior de la página

Similar models

Cognitive Function Substudy GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial