ID

26687

Beschreibung

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

Stichworte

Versionen (2)
  1. 21.09.17 21.09.17 -
  2. 23.10.17 23.10.17 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

23. Oktober 2017

DOI

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

Englisch

Substance use GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
History of tobacco use (baseline)
Beschreibung

History of tobacco use (baseline)

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

history of smoking use

Datentyp

integer

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

Last time subject smoked

Datentyp

date

Substance Use Type
Beschreibung

Substance Use Type baseline

Datentyp

text

History of tobacco use details (baseline)
Beschreibung

History of tobacco use details (baseline)

1. Average number of cigarettes smoked per day?
Beschreibung

cigarettes smoked per day

Datentyp

integer

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

years of tobacco use

Datentyp

integer

Maßeinheiten
  • years
years
Number of pack years?
Beschreibung

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.

Datentyp

integer

Current tobacco use (annual visit)
Beschreibung

Current tobacco use (annual visit)

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

Current tobacco use

Datentyp

boolean

Substance Use Type
Beschreibung

Substance Use Type annual visit

Datentyp

text

Current tobacco use details (annual visit)
Beschreibung

Current tobacco use details (annual visit)

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

Smoking in last year

Datentyp

boolean

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

cigarettes smoked per day

Datentyp

integer

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

Current tobacco use (end of treatment/early withdrawal)

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

current tobacco use end of treatment

Datentyp

boolean

Substance Use Type
Beschreibung

Substance Use Type end of treatment

Datentyp

text

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

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

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

Smoking since last annual visit

Datentyp

boolean

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

number of cigarettes per day end of treatment

Datentyp

integer

Alcohol intake (liver event)
Beschreibung

Alcohol intake (liver event)

1. Does the subject consume alcohol?
Beschreibung

Alcohol consumption

Datentyp

boolean

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

units of alcohol per week

Datentyp

float

Substance Use Type
Beschreibung

Substance Use Type liver alcohol

Datentyp

text

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Ähnliche Modelle

Substance use GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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