ID

25847

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: Substance use

Keywords

Versions (2)
  1. 9/21/17 9/21/17 -
  2. 10/23/17 10/23/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 21, 2017

DOI

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License

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

English

Substance use GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
History of tobacco use (baseline)
Description

History of tobacco use (baseline)

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

history of smoking use

Data type

integer

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

Last time subject smoked

Data type

date

Substance Use Type
Description

Substance Use Type baseline

Data type

text

History of tobacco use details (baseline)
Description

History of tobacco use details (baseline)

1. Average number of cigarettes smoked per day?
Description

cigarettes smoked per day

Data type

integer

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

years of tobacco use

Data type

integer

Measurement units
  • years
years
Number of pack years?
Description

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.

Data type

integer

Current tobacco use (annual visit)
Description

Current tobacco use (annual visit)

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

Current tobacco use

Data type

boolean

Substance Use Type
Description

Substance Use Type annual visit

Data type

text

Current tobacco use details (annual visit)
Description

Current tobacco use details (annual visit)

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

Smoking in last year

Data type

boolean

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

cigarettes smoked per day

Data type

integer

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

Current tobacco use (end of treatment/early withdrawal)

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

current tobacco use end of treatment

Data type

boolean

Substance Use Type
Description

Substance Use Type end of treatment

Data type

text

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

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

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

Smoking since last annual visit

Data type

boolean

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

number of cigarettes per day end of treatment

Data type

integer

Alcohol intake (liver event)
Description

Alcohol intake (liver event)

1. Does the subject consume alcohol?
Description

Alcohol consumption

Data type

boolean

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

units of alcohol per week

Data type

float

Substance Use Type
Description

Substance Use Type liver alcohol

Data type

text

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Similar models

Substance use GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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