ID

26680

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: Medical conditions of interest

Nyckelord

Versioner (3)
  1. 2017-08-27 2017-08-27 -
  2. 2017-10-23 2017-10-23 -
  3. 2017-12-12 2017-12-12 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 oktober 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

Engelsk

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär  
Cardiovascular conditions of interest
Beskrivning

Cardiovascular conditions of interest

1. Abdominal aortic aneurysm
Beskrivning

Abdominal aortic aneurysm

Datatyp

integer

2. Angina pectoris
Beskrivning

Angina pectoris

Datatyp

integer

3. Aortic valve disease
Beskrivning

Aortic valve disease

Datatyp

integer

4. Atrial flutter
Beskrivning

Atrial flutter

Datatyp

integer

5. Carotid artery disease
Beskrivning

Carotid artery disease

Datatyp

integer

6. Chronic atrial fibrillation
Beskrivning

Chronic atrial fibrillation

Datatyp

integer

7. Congestive heart failure
Beskrivning

Congestive heart failure

Datatyp

integer

If current, specify NYHA Functional Class code
Beskrivning

NYHA Functional Class code

Datatyp

integer

8. Dyslipidaemia
Beskrivning

Dyslipidaemia

Datatyp

integer

9. Hypercholesterolaemia
Beskrivning

Hypercholesterolaemia

Datatyp

integer

10. Hypertriglyceridaemia
Beskrivning

Hypertriglyceridaemia

Datatyp

integer

11. Low HDL cholesterol
Beskrivning

Low HDL cholesterol

Datatyp

integer

12. Hypertension
Beskrivning

Hypertension

Datatyp

integer

13. Mitral valve disease
Beskrivning

Mitral valve disease

Datatyp

integer

14. Peripheral vascular disease, lower extremities
Beskrivning

Peripheral vascular disease, lower extremities

Datatyp

integer

15. Peripheral vascular disease, other
Beskrivning

Peripheral vascular disease, other

Datatyp

integer

16. Paroxysmal atrial fibrillation
Beskrivning

Paroxysmal atrial fibrillation

Datatyp

integer

17. Transient ischaemic attack
Beskrivning

Transient ischaemic attack

Datatyp

integer

18. Type II diabetes mellitus not requiring pharmacotherapy
Beskrivning

Type II diabetes mellitus not requiring pharmacotherapy

Datatyp

integer

Sequence Number
Beskrivning

Sequence Number

Datatyp

text

Specific Condition
Beskrivning

Specific Condition

Datatyp

text

Modified Term
Beskrivning

Modified Term

Datatyp

text

MedDRA Synonym
Beskrivning

MedDRA Synonym

Datatyp

text

MedDRA lower level term code
Beskrivning

MedDRA lower level term code

Datatyp

text

Failed coding
Beskrivning

Failed coding

Datatyp

text

Status
Beskrivning

Status

Datatyp

text

Other cardiovascular conditions
Beskrivning

Other cardiovascular conditions

19.a Sequence Number
Beskrivning

Sequence Number other

Datatyp

text

19.b Specific Condition
Beskrivning

Specific Condition other

Datatyp

text

19.c Modified Term
Beskrivning

Modified Term other

Datatyp

text

MedDRA Synonym
Beskrivning

MedDRA Synonym other

Datatyp

text

MedDRA lower level term code
Beskrivning

MedDRA lower level term code other

Datatyp

text

Failed coding
Beskrivning

Failed coding other

Datatyp

text

19.d Status
Beskrivning

Status other

Datatyp

integer

Other medical conditions of interest
Beskrivning

Other medical conditions of interest

20. Asthma
Beskrivning

Asthma

Datatyp

integer

21. Chronic obstructive pulmonary disease
Beskrivning

Chronic obstructive pulmonary disease

Datatyp

integer

If current, requiring oxygen therapy?
Beskrivning

Chronic obstructive pulmonary disease oxygen therapy

Datatyp

integer

22. Sleep apnoea
Beskrivning

Sleep apnoea

Datatyp

integer

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

Sleep apnoea ventilation

Datatyp

integer

23. Renal disease other than diabetic nephropathy
Beskrivning

Renal disease other than diabetic nephropathy

Datatyp

integer

Tillbaka till toppen

Similar models

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial