ID

26687

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: Substance use

Nyckelord

Versioner (2)
  1. 2017-09-21 2017-09-21 -
  2. 2017-10-23 2017-10-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 oktober 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Substance use GSK study Chronic Coronary Heart Disease NCT00799903

Engelsk

Substance use GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär  
History of tobacco use (baseline)
Beskrivning

History of tobacco use (baseline)

1. What is the subject's history of smoking use?
Beskrivning

history of smoking use

Datatyp

integer

If former smoker, when did the subject last smoke?
Beskrivning

Last time subject smoked

Datatyp

date

Substance Use Type
Beskrivning

Substance Use Type baseline

Datatyp

text

History of tobacco use details (baseline)
Beskrivning

History of tobacco use details (baseline)

1. Average number of cigarettes smoked per day?
Beskrivning

cigarettes smoked per day

Datatyp

integer

2. Number of years during which the subject has smoked/used tobacco?
Beskrivning

years of tobacco use

Datatyp

integer

Måttenheter
  • years
years
Number of pack years?
Beskrivning

This item will be calcuated by InForm using the following formula: Average number of cigarettes smoked per day divided by 20 and then multiplied by number of years smoked. Round up/down to nearest integer.

Datatyp

integer

Current tobacco use (annual visit)
Beskrivning

Current tobacco use (annual visit)

Does the subject currently smoke or have they smoked in the last year?
Beskrivning

Current tobacco use

Datatyp

boolean

Substance Use Type
Beskrivning

Substance Use Type annual visit

Datatyp

text

Current tobacco use details (annual visit)
Beskrivning

Current tobacco use details (annual visit)

1. Has the subject smoked in the last 12 months?
Beskrivning

Smoking in last year

Datatyp

boolean

If yes, record average number of cigarettes smoked per day
Beskrivning

cigarettes smoked per day

Datatyp

integer

Current tobacco use (end of treatment/early withdrawal)
Beskrivning

Current tobacco use (end of treatment/early withdrawal)

1. Does the subject currently smoke or have they smoked since the last annual visit?
Beskrivning

current tobacco use end of treatment

Datatyp

boolean

Substance Use Type
Beskrivning

Substance Use Type end of treatment

Datatyp

text

Current tobacco use details (end of treatment/early withdrawal)
Beskrivning

Current tobacco use details (end of treatment/early withdrawal)

1. Has the subject smoked since the last annual visit?
Beskrivning

Smoking since last annual visit

Datatyp

boolean

If yes, record average number of cigarettes smoked per day
Beskrivning

number of cigarettes per day end of treatment

Datatyp

integer

Alcohol intake (liver event)
Beskrivning

Alcohol intake (liver event)

1. Does the subject consume alcohol?
Beskrivning

Alcohol consumption

Datatyp

boolean

If yes, record the average number of units of alcohol consumed per week
Beskrivning

units of alcohol per week

Datatyp

float

Substance Use Type
Beskrivning

Substance Use Type liver alcohol

Datatyp

text

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Similar models

Substance use GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
History of tobacco use (baseline)
Item
1. What is the subject's history of smoking use?
integer
Date of visit/assessment
Code List
1. What is the subject's history of smoking use?
CL Item
Never smoked (1)
CL Item
Current smoker (2)
CL Item
Former smoker (3)
Last time subject smoked
Item
If former smoker, when did the subject last smoke?
date
Substance Use Type baseline
Item
Substance Use Type
text
Item Group
History of tobacco use details (baseline)
cigarettes smoked per day
Item
1. Average number of cigarettes smoked per day?
integer
years of tobacco use
Item
2. Number of years during which the subject has smoked/used tobacco?
integer
Number of pack years
Item
Number of pack years?
integer
Item Group
Current tobacco use (annual visit)
Current tobacco use
Item
Does the subject currently smoke or have they smoked in the last year?
boolean
Substance Use Type annual visit
Item
Substance Use Type
text
Item Group
Current tobacco use details (annual visit)
Smoking in last year
Item
1. Has the subject smoked in the last 12 months?
boolean
cigarettes smoked per day
Item
If yes, record average number of cigarettes smoked per day
integer
Item Group
Current tobacco use (end of treatment/early withdrawal)
current tobacco use end of treatment
Item
1. Does the subject currently smoke or have they smoked since the last annual visit?
boolean
Substance Use Type end of treatment
Item
Substance Use Type
text
Item Group
Current tobacco use details (end of treatment/early withdrawal)
Smoking since last annual visit
Item
1. Has the subject smoked since the last annual visit?
boolean
number of cigarettes per day end of treatment
Item
If yes, record average number of cigarettes smoked per day
integer
Item Group
Alcohol intake (liver event)
Alcohol consumption
Item
1. Does the subject consume alcohol?
boolean
units of alcohol per week
Item
If yes, record the average number of units of alcohol consumed per week
float
Substance Use Type liver alcohol
Item
Substance Use Type
text
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