ID

25065

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: Screening/Enrollment

Keywords

Versions (6)
  1. 8/25/17 8/25/17 -
  2. 8/25/17 8/25/17 -
  3. 8/25/17 8/25/17 -
  4. 10/13/17 10/13/17 -
  5. 10/23/17 10/23/17 -
  6. 12/12/17 12/12/17 -
Uploaded on

August 25, 2017

DOI

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License

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

English

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 forms  
Screening
Description

Screening

1. Subject initials
Description

Subject initials

Data type

text

2. Date of birth
Description

Date of birth

Data type

date

3. eGFR value used for screening
Description

eGFR

Data type

integer

4. Was this subject a screen failure?
Description

If Yes, check all that apply

Data type

boolean

Reason for screen failure
Description

Reason for screen failure

[F01] Did not meet inclusion/exclusion criteria, specify:
Description

Inclusion exclusion criteria

Data type

boolean

[I02] Inclusion Criteria 2
Description

Inclusion Criteria 2

Data type

boolean

[I03] Inclusion Criteria 3
Description

Inclusion Criteria 3

Data type

boolean

[I04] Inclusion Criteria 4
Description

Inclusion Criteria 4

Data type

boolean

[I05] Inclusion Criteria 5
Description

Inclusion Criteria 5

Data type

boolean

[E01] Exclusion Criteria 1
Description

Exclusion Criteria 1

Data type

boolean

[E02] Exclusion Criteria 2
Description

Exclusion Criteria 2

Data type

boolean

[E03] Exclusion Criteria 3
Description

Exclusion Criteria 3

Data type

boolean

[E04] Exclusion Criteria 4
Description

Exclusion Criteria 4

Data type

boolean

[E05] Exclusion Criteria 5
Description

Exclusion Criteria 5

Data type

text

[E06] Exclusion Criteria 6
Description

Exclusion Criteria 6

Data type

boolean

[E07] Exclusion Criteria 7
Description

Exclusion Criteria 7

Data type

boolean

[E08] Exclusion Criteria 8
Description

Exclusion Criteria 8

Data type

boolean

[E09] Exclusion Criteria 9
Description

Exclusion Criteria 9

Data type

boolean

[E10] Exclusion Criteria 10
Description

Exclusion Criteria 10

Data type

boolean

[E11] Exclusion Criteria 11
Description

Exclusion Criteria 11

Data type

boolean

[E12] Exclusion Criteria 12
Description

Exclusion Criteria 12

Data type

boolean

[E13] Exclusion Criteria 13
Description

Exclusion Criteria 13

Data type

boolean

[E14] Exclusion Criteria 14
Description

Exclusion Criteria 14

Data type

boolean

[E15] Exclusion Criteria 15
Description

Exclusion Criteria 15

Data type

boolean

[E16] Exclusion Criteria 16
Description

Exclusion Criteria 16

Data type

boolean

[E16] Exclusion Criteria 16, specify:
Description

Exclusion Criteria 16, specification

Data type

text

[F10] Subject withdrew consent prior to randomisation
Description

Withdrawal of consent

Data type

boolean

[F06] Study closed/terminated prior to randomisation
Description

Study closed/terminated

Data type

boolean

[F07] Lost to follow up prior to randomisation
Description

Lost to follow up

Data type

boolean

Enrollment
Description

Enrollment

1. Subject number
Description

Subject number

Data type

text

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Similar models

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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, specify:
boolean
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
text
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
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
Enrollment
Subject number
Item
1. Subject number
text
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