ID

25065

Beschrijving

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

Trefwoorden

Versies (6)
  1. 25-08-17 25-08-17 -
  2. 25-08-17 25-08-17 -
  3. 25-08-17 25-08-17 -
  4. 13-10-17 13-10-17 -
  5. 23-10-17 23-10-17 -
  6. 12-12-17 12-12-17 -
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25 augustus 2017

DOI

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Licentie

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

Engels

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 Formulieren  
Screening
Beschrijving

Screening

1. Subject initials
Beschrijving

Subject initials

Datatype

text

2. Date of birth
Beschrijving

Date of birth

Datatype

date

3. eGFR value used for screening
Beschrijving

eGFR

Datatype

integer

4. Was this subject a screen failure?
Beschrijving

If Yes, check all that apply

Datatype

boolean

Reason for screen failure
Beschrijving

Reason for screen failure

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

Inclusion exclusion criteria

Datatype

boolean

[I02] Inclusion Criteria 2
Beschrijving

Inclusion Criteria 2

Datatype

boolean

[I03] Inclusion Criteria 3
Beschrijving

Inclusion Criteria 3

Datatype

boolean

[I04] Inclusion Criteria 4
Beschrijving

Inclusion Criteria 4

Datatype

boolean

[I05] Inclusion Criteria 5
Beschrijving

Inclusion Criteria 5

Datatype

boolean

[E01] Exclusion Criteria 1
Beschrijving

Exclusion Criteria 1

Datatype

boolean

[E02] Exclusion Criteria 2
Beschrijving

Exclusion Criteria 2

Datatype

boolean

[E03] Exclusion Criteria 3
Beschrijving

Exclusion Criteria 3

Datatype

boolean

[E04] Exclusion Criteria 4
Beschrijving

Exclusion Criteria 4

Datatype

boolean

[E05] Exclusion Criteria 5
Beschrijving

Exclusion Criteria 5

Datatype

text

[E06] Exclusion Criteria 6
Beschrijving

Exclusion Criteria 6

Datatype

boolean

[E07] Exclusion Criteria 7
Beschrijving

Exclusion Criteria 7

Datatype

boolean

[E08] Exclusion Criteria 8
Beschrijving

Exclusion Criteria 8

Datatype

boolean

[E09] Exclusion Criteria 9
Beschrijving

Exclusion Criteria 9

Datatype

boolean

[E10] Exclusion Criteria 10
Beschrijving

Exclusion Criteria 10

Datatype

boolean

[E11] Exclusion Criteria 11
Beschrijving

Exclusion Criteria 11

Datatype

boolean

[E12] Exclusion Criteria 12
Beschrijving

Exclusion Criteria 12

Datatype

boolean

[E13] Exclusion Criteria 13
Beschrijving

Exclusion Criteria 13

Datatype

boolean

[E14] Exclusion Criteria 14
Beschrijving

Exclusion Criteria 14

Datatype

boolean

[E15] Exclusion Criteria 15
Beschrijving

Exclusion Criteria 15

Datatype

boolean

[E16] Exclusion Criteria 16
Beschrijving

Exclusion Criteria 16

Datatype

boolean

[E16] Exclusion Criteria 16, specify:
Beschrijving

Exclusion Criteria 16, specification

Datatype

text

[F10] Subject withdrew consent prior to randomisation
Beschrijving

Withdrawal of consent

Datatype

boolean

[F06] Study closed/terminated prior to randomisation
Beschrijving

Study closed/terminated

Datatype

boolean

[F07] Lost to follow up prior to randomisation
Beschrijving

Lost to follow up

Datatype

boolean

Enrollment
Beschrijving

Enrollment

1. Subject number
Beschrijving

Subject number

Datatype

text

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Similar models

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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