ID

25067

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: Screening/Enrollment

Palabras clave

Versiones (6)
  1. 25/8/17 25/8/17 -
  2. 25/8/17 25/8/17 -
  3. 25/8/17 25/8/17 -
  4. 13/10/17 13/10/17 -
  5. 23/10/17 23/10/17 -
  6. 12/12/17 12/12/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

25 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Screening/Enrollment GSK study Chronic Coronary Heart Disease NCT00799903

Inglés

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 formularios  
Screening
Descripción

Screening

1. Subject initials
Descripción

Subject initials

Tipo de datos

text

2. Date of birth
Descripción

Date of birth

Tipo de datos

date

3. eGFR value used for screening
Descripción

eGFR

Tipo de datos

integer

4. Was this subject a screen failure?
Descripción

If Yes, check all that apply

Tipo de datos

boolean

Reason for screen failure
Descripción

Reason for screen failure

[F01] Did not meet inclusion/exclusion criteria
Descripción

Inclusion exclusion criteria

Tipo de datos

boolean

[F10] Subject withdrew consent prior to randomisation
Descripción

Withdrawal of consent

Tipo de datos

boolean

[F06] Study closed/terminated prior to randomisation
Descripción

Study closed/terminated

Tipo de datos

boolean

[F07] Lost to follow up prior to randomisation
Descripción

Lost to follow up

Tipo de datos

boolean

If subject did not meet inclusion/exclusion criteria, specify:
Descripción

If subject did not meet inclusion/exclusion criteria, specify:

[I02] Inclusion Criteria 2
Descripción

Inclusion Criteria 2

Tipo de datos

boolean

[I03] Inclusion Criteria 3
Descripción

Inclusion Criteria 3

Tipo de datos

boolean

[I04] Inclusion Criteria 4
Descripción

Inclusion Criteria 4

Tipo de datos

boolean

[I05] Inclusion Criteria 5
Descripción

Inclusion Criteria 5

Tipo de datos

boolean

[E01] Exclusion Criteria 1
Descripción

Exclusion Criteria 1

Tipo de datos

boolean

[E02] Exclusion Criteria 2
Descripción

Exclusion Criteria 2

Tipo de datos

boolean

[E03] Exclusion Criteria 3
Descripción

Exclusion Criteria 3

Tipo de datos

boolean

[E04] Exclusion Criteria 4
Descripción

Exclusion Criteria 4

Tipo de datos

boolean

[E05] Exclusion Criteria 5
Descripción

Exclusion Criteria 5

Tipo de datos

boolean

[E06] Exclusion Criteria 6
Descripción

Exclusion Criteria 6

Tipo de datos

boolean

[E07] Exclusion Criteria 7
Descripción

Exclusion Criteria 7

Tipo de datos

boolean

[E08] Exclusion Criteria 8
Descripción

Exclusion Criteria 8

Tipo de datos

boolean

[E09] Exclusion Criteria 9
Descripción

Exclusion Criteria 9

Tipo de datos

boolean

[E10] Exclusion Criteria 10
Descripción

Exclusion Criteria 10

Tipo de datos

boolean

[E11] Exclusion Criteria 11
Descripción

Exclusion Criteria 11

Tipo de datos

boolean

[E12] Exclusion Criteria 12
Descripción

Exclusion Criteria 12

Tipo de datos

boolean

[E13] Exclusion Criteria 13
Descripción

Exclusion Criteria 13

Tipo de datos

boolean

[E14] Exclusion Criteria 14
Descripción

Exclusion Criteria 14

Tipo de datos

boolean

[E15] Exclusion Criteria 15
Descripción

Exclusion Criteria 15

Tipo de datos

boolean

[E16] Exclusion Criteria 16
Descripción

Exclusion Criteria 16

Tipo de datos

boolean

[E16] Exclusion Criteria 16, specify:
Descripción

Exclusion Criteria 16, specification

Tipo de datos

text

Enrollment
Descripción

Enrollment

1. Subject number
Descripción

Subject number

Tipo de datos

text

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Similar models

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Screening
Subject initials
Item
1. Subject initials
text
Date of birth
Item
2. Date of birth
date
eGFR
Item
3. eGFR value used for screening
integer
screen failure
Item
4. Was this subject a screen failure?
boolean
Item Group
Reason for screen failure
Inclusion exclusion criteria
Item
[F01] Did not meet inclusion/exclusion criteria
boolean
Withdrawal of consent
Item
[F10] Subject withdrew consent prior to randomisation
boolean
Study closed/terminated
Item
[F06] Study closed/terminated prior to randomisation
boolean
Lost to follow up
Item
[F07] Lost to follow up prior to randomisation
boolean
Item Group
If subject did not meet inclusion/exclusion criteria, specify:
Inclusion Criteria 2
Item
[I02] Inclusion Criteria 2
boolean
Inclusion Criteria 3
Item
[I03] Inclusion Criteria 3
boolean
Inclusion Criteria 4
Item
[I04] Inclusion Criteria 4
boolean
Inclusion Criteria 5
Item
[I05] Inclusion Criteria 5
boolean
Exclusion Criteria 1
Item
[E01] Exclusion Criteria 1
boolean
Exclusion Criteria 2
Item
[E02] Exclusion Criteria 2
boolean
Exclusion Criteria 3
Item
[E03] Exclusion Criteria 3
boolean
Exclusion Criteria 4
Item
[E04] Exclusion Criteria 4
boolean
Exclusion Criteria 5
Item
[E05] Exclusion Criteria 5
boolean
Exclusion Criteria 6
Item
[E06] Exclusion Criteria 6
boolean
Exclusion Criteria 7
Item
[E07] Exclusion Criteria 7
boolean
Exclusion Criteria 8
Item
[E08] Exclusion Criteria 8
boolean
Exclusion Criteria 9
Item
[E09] Exclusion Criteria 9
boolean
Exclusion Criteria 10
Item
[E10] Exclusion Criteria 10
boolean
Exclusion Criteria 11
Item
[E11] Exclusion Criteria 11
boolean
Exclusion Criteria 12
Item
[E12] Exclusion Criteria 12
boolean
Exclusion Criteria 13
Item
[E13] Exclusion Criteria 13
boolean
Exclusion Criteria 14
Item
[E14] Exclusion Criteria 14
boolean
Exclusion Criteria 15
Item
[E15] Exclusion Criteria 15
boolean
Exclusion Criteria 16
Item
[E16] Exclusion Criteria 16
boolean
Exclusion Criteria 16, specification
Item
[E16] Exclusion Criteria 16, specify:
text
Item Group
Enrollment
Subject number
Item
1. Subject number
text
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