ID

25149

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: Medical conditions of interest

Keywords

Versions (3)
  1. 8/27/17 8/27/17 -
  2. 10/23/17 10/23/17 -
  3. 12/12/17 12/12/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 27, 2017

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License

Creative Commons BY-NC 3.0
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Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

English

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Cardiovascular conditions of interest
Description

Cardiovascular conditions of interest

1. Abdominal aortic aneurysm
Description

Abdominal aortic aneurysm

Data type

integer

2. Angina pectoris
Description

Angina pectoris

Data type

integer

3. Aortic valve disease
Description

Aortic valve disease

Data type

integer

4. Atrial flutter
Description

Atrial flutter

Data type

integer

5. Carotid artery disease
Description

Carotid artery disease

Data type

integer

6. Chronic atrial fibrillation
Description

Chronic atrial fibrillation

Data type

integer

7. Congestive heart failure
Description

Congestive heart failure

Data type

integer

If current, specify NYHA Functional Class code
Description

NYHA Functional Class code

Data type

integer

8. Dyslipidaemia
Description

Dyslipidaemia

Data type

integer

9. Hypercholesterolaemia
Description

Hypercholesterolaemia

Data type

integer

10. Hypertriglyceridaemia
Description

Hypertriglyceridaemia

Data type

integer

11. Low HDL cholesterol
Description

Low HDL cholesterol

Data type

integer

12. Hypertension
Description

Hypertension

Data type

integer

13. Mitral valve disease
Description

Mitral valve disease

Data type

integer

14. Peripheral vascular disease, lower extremities
Description

Peripheral vascular disease, lower extremities

Data type

integer

15. Peripheral vascular disease, other
Description

Peripheral vascular disease, other

Data type

integer

16. Paroxysmal atrial fibrillation
Description

Paroxysmal atrial fibrillation

Data type

integer

17. Transient ischaemic attack
Description

Transient ischaemic attack

Data type

integer

18. Type II diabetes mellitus not requiring pharmacotherapy
Description

Type II diabetes mellitus not requiring pharmacotherapy

Data type

integer

Sequence Number
Description

Sequence Number

Data type

text

Specific Condition
Description

Specific Condition

Data type

text

Modified Term
Description

Modified Term

Data type

text

MedDRA Synonym
Description

MedDRA Synonym

Data type

text

MedDRA lower level term code
Description

MedDRA lower level term code

Data type

text

Failed coding
Description

Failed coding

Data type

text

Status
Description

Status

Data type

text

Other cardiovascular conditions
Description

Other cardiovascular conditions

19.a Sequence Number
Description

Sequence Number other

Data type

text

19.b Specific Condition
Description

Specific Condition other

Data type

text

19.c Modified Term
Description

Modified Term other

Data type

text

MedDRA Synonym
Description

MedDRA Synonym other

Data type

text

MedDRA lower level term code
Description

MedDRA lower level term code other

Data type

text

Failed coding
Description

Failed coding other

Data type

text

19.d Status
Description

Status other

Data type

integer

Other medical conditions of interest
Description

Other medical conditions of interest

20. Asthma
Description

Asthma

Data type

integer

21. Chronic obstructive pulmonary disease
Description

Chronic obstructive pulmonary disease

Data type

integer

If current, requiring oxygen therapy?
Description

Chronic obstructive pulmonary disease oxygen therapy

Data type

integer

22. Sleep apnoea
Description

Sleep apnoea

Data type

integer

If current, requiring non-invasive ventilation [e.g., CPAP or BiPAP]?
Description

Sleep apnoea ventilation

Data type

integer

23. Renal disease other than diabetic nephropathy
Description

Renal disease other than diabetic nephropathy

Data type

integer

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Similar models

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Cardiovascular conditions of interest
Item
1. Abdominal aortic aneurysm
integer
Aortic dissection
Code List
1. Abdominal aortic aneurysm
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
2. Angina pectoris
integer
Aortic dissection
Code List
2. Angina pectoris
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
3. Aortic valve disease
integer
Aortic dissection
Code List
3. Aortic valve disease
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
4. Atrial flutter
integer
Aortic dissection
Code List
4. Atrial flutter
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
5. Carotid artery disease
integer
Aortic dissection
Code List
5. Carotid artery disease
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
6. Chronic atrial fibrillation
integer
Aortic dissection
Code List
6. Chronic atrial fibrillation
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
7. Congestive heart failure
integer
Aortic dissection
Code List
7. Congestive heart failure
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
If current, specify NYHA Functional Class code
integer
NYHA Functional Class code
Code List
If current, specify NYHA Functional Class code
CL Item
Class I (1)
CL Item
Class II (2)
CL Item
Class III (3)
CL Item
Class IV (4)
Item
8. Dyslipidaemia
integer
Aortic dissection
Code List
8. Dyslipidaemia
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
9. Hypercholesterolaemia
integer
Aortic dissection
Code List
9. Hypercholesterolaemia
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
10. Hypertriglyceridaemia
integer
Aortic dissection
Code List
10. Hypertriglyceridaemia
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
11. Low HDL cholesterol
integer
Cardiac arrest
Code List
11. Low HDL cholesterol
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
Item
12. Hypertension
integer
Aortic dissection
Code List
12. Hypertension
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
13. Mitral valve disease
integer
Aortic dissection
Code List
13. Mitral valve disease
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
14. Peripheral vascular disease, lower extremities
integer
Aortic dissection
Code List
14. Peripheral vascular disease, lower extremities
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
15. Peripheral vascular disease, other
integer
Aortic dissection
Code List
15. Peripheral vascular disease, other
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
16. Paroxysmal atrial fibrillation
integer
Aortic dissection
Code List
16. Paroxysmal atrial fibrillation
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
17. Transient ischaemic attack
integer
Aortic dissection
Code List
17. Transient ischaemic attack
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
18. Type II diabetes mellitus not requiring pharmacotherapy
integer
Aortic dissection
Code List
18. Type II diabetes mellitus not requiring pharmacotherapy
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Sequence Number
Item
Sequence Number
text
Specific Condition
Item
Specific Condition
text
Modified Term
Item
Modified Term
text
MedDRA Synonym
Item
MedDRA Synonym
text
MedDRA lower level term code
Item
MedDRA lower level term code
text
Failed coding
Item
Failed coding
text
Status
Item
Status
text
Item Group
Other cardiovascular conditions
Sequence Number other
Item
19.a Sequence Number
text
Specific Condition other
Item
19.b Specific Condition
text
Modified Term other
Item
19.c Modified Term
text
MedDRA Synonym other
Item
MedDRA Synonym
text
MedDRA lower level term code other
Item
MedDRA lower level term code
text
Failed coding other
Item
Failed coding
text
Item
19.d Status
integer
Status other
Code List
19.d Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions of interest
Item
20. Asthma
integer
Aortic dissection
Code List
20. Asthma
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
21. Chronic obstructive pulmonary disease
integer
Aortic dissection
Code List
21. Chronic obstructive pulmonary disease
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
If current, requiring oxygen therapy?
integer
Aortic dissection
Code List
If current, requiring oxygen therapy?
CL Item
Yes (1)
CL Item
No (0)
Item
22. Sleep apnoea
integer
Aortic dissection
Code List
22. Sleep apnoea
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
Item
If current, requiring non-invasive ventilation [e.g., CPAP or BiPAP]?
integer
Aortic dissection
Code List
If current, requiring non-invasive ventilation [e.g., CPAP or BiPAP]?
CL Item
Yes (1)
CL Item
No (0)
Item
23. Renal disease other than diabetic nephropathy
integer
Aortic dissection
Code List
23. Renal disease other than diabetic nephropathy
CL Item
Past (2)
CL Item
Current (1)
CL Item
No Medical Condition (5)
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