ID

25065

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: Screening/Enrollment

Nyckelord

Versioner (6)
  1. 2017-08-25 2017-08-25 -
  2. 2017-08-25 2017-08-25 -
  3. 2017-08-25 2017-08-25 -
  4. 2017-10-13 2017-10-13 -
  5. 2017-10-23 2017-10-23 -
  6. 2017-12-12 2017-12-12 -
Uppladdad den

25 augusti 2017

DOI

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

Engelsk

Screening/Enrollment GSK study Chronic CHD NCT00799903

1 Formulär  
Screening
Beskrivning

Screening

1. Subject initials
Beskrivning

Subject initials

Datatyp

text

2. Date of birth
Beskrivning

Date of birth

Datatyp

date

3. eGFR value used for screening
Beskrivning

eGFR

Datatyp

integer

4. Was this subject a screen failure?
Beskrivning

If Yes, check all that apply

Datatyp

boolean

Reason for screen failure
Beskrivning

Reason for screen failure

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

Inclusion exclusion criteria

Datatyp

boolean

[I02] Inclusion Criteria 2
Beskrivning

Inclusion Criteria 2

Datatyp

boolean

[I03] Inclusion Criteria 3
Beskrivning

Inclusion Criteria 3

Datatyp

boolean

[I04] Inclusion Criteria 4
Beskrivning

Inclusion Criteria 4

Datatyp

boolean

[I05] Inclusion Criteria 5
Beskrivning

Inclusion Criteria 5

Datatyp

boolean

[E01] Exclusion Criteria 1
Beskrivning

Exclusion Criteria 1

Datatyp

boolean

[E02] Exclusion Criteria 2
Beskrivning

Exclusion Criteria 2

Datatyp

boolean

[E03] Exclusion Criteria 3
Beskrivning

Exclusion Criteria 3

Datatyp

boolean

[E04] Exclusion Criteria 4
Beskrivning

Exclusion Criteria 4

Datatyp

boolean

[E05] Exclusion Criteria 5
Beskrivning

Exclusion Criteria 5

Datatyp

text

[E06] Exclusion Criteria 6
Beskrivning

Exclusion Criteria 6

Datatyp

boolean

[E07] Exclusion Criteria 7
Beskrivning

Exclusion Criteria 7

Datatyp

boolean

[E08] Exclusion Criteria 8
Beskrivning

Exclusion Criteria 8

Datatyp

boolean

[E09] Exclusion Criteria 9
Beskrivning

Exclusion Criteria 9

Datatyp

boolean

[E10] Exclusion Criteria 10
Beskrivning

Exclusion Criteria 10

Datatyp

boolean

[E11] Exclusion Criteria 11
Beskrivning

Exclusion Criteria 11

Datatyp

boolean

[E12] Exclusion Criteria 12
Beskrivning

Exclusion Criteria 12

Datatyp

boolean

[E13] Exclusion Criteria 13
Beskrivning

Exclusion Criteria 13

Datatyp

boolean

[E14] Exclusion Criteria 14
Beskrivning

Exclusion Criteria 14

Datatyp

boolean

[E15] Exclusion Criteria 15
Beskrivning

Exclusion Criteria 15

Datatyp

boolean

[E16] Exclusion Criteria 16
Beskrivning

Exclusion Criteria 16

Datatyp

boolean

[E16] Exclusion Criteria 16, specify:
Beskrivning

Exclusion Criteria 16, specification

Datatyp

text

[F10] Subject withdrew consent prior to randomisation
Beskrivning

Withdrawal of consent

Datatyp

boolean

[F06] Study closed/terminated prior to randomisation
Beskrivning

Study closed/terminated

Datatyp

boolean

[F07] Lost to follow up prior to randomisation
Beskrivning

Lost to follow up

Datatyp

boolean

Enrollment
Beskrivning

Enrollment

1. Subject number
Beskrivning

Subject number

Datatyp

text

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Similar models

Screening/Enrollment GSK study Chronic CHD NCT00799903

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

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