ID

25149

Beschrijving

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

Trefwoorden

Versies (3)
  1. 27-08-17 27-08-17 -
  2. 23-10-17 23-10-17 -
  3. 12-12-17 12-12-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

27 augustus 2017

DOI

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Licentie

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

Engels

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
Cardiovascular conditions of interest
Beschrijving

Cardiovascular conditions of interest

1. Abdominal aortic aneurysm
Beschrijving

Abdominal aortic aneurysm

Datatype

integer

2. Angina pectoris
Beschrijving

Angina pectoris

Datatype

integer

3. Aortic valve disease
Beschrijving

Aortic valve disease

Datatype

integer

4. Atrial flutter
Beschrijving

Atrial flutter

Datatype

integer

5. Carotid artery disease
Beschrijving

Carotid artery disease

Datatype

integer

6. Chronic atrial fibrillation
Beschrijving

Chronic atrial fibrillation

Datatype

integer

7. Congestive heart failure
Beschrijving

Congestive heart failure

Datatype

integer

If current, specify NYHA Functional Class code
Beschrijving

NYHA Functional Class code

Datatype

integer

8. Dyslipidaemia
Beschrijving

Dyslipidaemia

Datatype

integer

9. Hypercholesterolaemia
Beschrijving

Hypercholesterolaemia

Datatype

integer

10. Hypertriglyceridaemia
Beschrijving

Hypertriglyceridaemia

Datatype

integer

11. Low HDL cholesterol
Beschrijving

Low HDL cholesterol

Datatype

integer

12. Hypertension
Beschrijving

Hypertension

Datatype

integer

13. Mitral valve disease
Beschrijving

Mitral valve disease

Datatype

integer

14. Peripheral vascular disease, lower extremities
Beschrijving

Peripheral vascular disease, lower extremities

Datatype

integer

15. Peripheral vascular disease, other
Beschrijving

Peripheral vascular disease, other

Datatype

integer

16. Paroxysmal atrial fibrillation
Beschrijving

Paroxysmal atrial fibrillation

Datatype

integer

17. Transient ischaemic attack
Beschrijving

Transient ischaemic attack

Datatype

integer

18. Type II diabetes mellitus not requiring pharmacotherapy
Beschrijving

Type II diabetes mellitus not requiring pharmacotherapy

Datatype

integer

Sequence Number
Beschrijving

Sequence Number

Datatype

text

Specific Condition
Beschrijving

Specific Condition

Datatype

text

Modified Term
Beschrijving

Modified Term

Datatype

text

MedDRA Synonym
Beschrijving

MedDRA Synonym

Datatype

text

MedDRA lower level term code
Beschrijving

MedDRA lower level term code

Datatype

text

Failed coding
Beschrijving

Failed coding

Datatype

text

Status
Beschrijving

Status

Datatype

text

Other cardiovascular conditions
Beschrijving

Other cardiovascular conditions

19.a Sequence Number
Beschrijving

Sequence Number other

Datatype

text

19.b Specific Condition
Beschrijving

Specific Condition other

Datatype

text

19.c Modified Term
Beschrijving

Modified Term other

Datatype

text

MedDRA Synonym
Beschrijving

MedDRA Synonym other

Datatype

text

MedDRA lower level term code
Beschrijving

MedDRA lower level term code other

Datatype

text

Failed coding
Beschrijving

Failed coding other

Datatype

text

19.d Status
Beschrijving

Status other

Datatype

integer

Other medical conditions of interest
Beschrijving

Other medical conditions of interest

20. Asthma
Beschrijving

Asthma

Datatype

integer

21. Chronic obstructive pulmonary disease
Beschrijving

Chronic obstructive pulmonary disease

Datatype

integer

If current, requiring oxygen therapy?
Beschrijving

Chronic obstructive pulmonary disease oxygen therapy

Datatype

integer

22. Sleep apnoea
Beschrijving

Sleep apnoea

Datatype

integer

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

Sleep apnoea ventilation

Datatype

integer

23. Renal disease other than diabetic nephropathy
Beschrijving

Renal disease other than diabetic nephropathy

Datatype

integer

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Similar models

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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