ID

28045

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: Medical conditions of interest

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Versionen (3)
  1. 27.08.17 27.08.17 -
  2. 23.10.17 23.10.17 -
  3. 12.12.17 12.12.17 -
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GlaxoSmithKline

Hochgeladen am

12. Dezember 2017

DOI

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Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
Cardiovascular conditions of interest
Beschreibung

Cardiovascular conditions of interest

1. Abdominal aortic aneurysm
Beschreibung

Abdominal aortic aneurysm

Datentyp

integer

Alias
UMLS CUI [1]
C0162871
2. Angina pectoris
Beschreibung

Angina pectoris

Datentyp

integer

Alias
UMLS CUI [1]
C0002962
3. Aortic valve disease
Beschreibung

Aortic valve disease

Datentyp

integer

Alias
UMLS CUI [1]
C1260873
4. Atrial flutter
Beschreibung

Atrial flutter

Datentyp

integer

Alias
UMLS CUI [1]
C0004239
5. Carotid artery disease
Beschreibung

Carotid artery disease

Datentyp

integer

Alias
UMLS CUI [1]
C0007273
6. Chronic atrial fibrillation
Beschreibung

Chronic atrial fibrillation

Datentyp

integer

Alias
UMLS CUI [1]
C0694539
7. Congestive heart failure
Beschreibung

Congestive heart failure

Datentyp

integer

Alias
UMLS CUI [1]
C0018802
If current, specify NYHA Functional Class code
Beschreibung

NYHA Functional Class code

Datentyp

integer

Alias
UMLS CUI [1]
C1275491
8. Dyslipidaemia
Beschreibung

Dyslipidaemia

Datentyp

integer

Alias
UMLS CUI [1]
C0242339
9. Hypercholesterolaemia
Beschreibung

Hypercholesterolaemia

Datentyp

integer

Alias
UMLS CUI [1]
C0020443
10. Hypertriglyceridaemia
Beschreibung

Hypertriglyceridaemia

Datentyp

integer

Alias
UMLS CUI [1]
C0020557
11. Low HDL cholesterol
Beschreibung

Low HDL cholesterol

Datentyp

integer

Alias
UMLS CUI [1]
C0151691
12. Hypertension
Beschreibung

Hypertension

Datentyp

integer

Alias
UMLS CUI [1]
C0020538
13. Mitral valve disease
Beschreibung

Mitral valve disease

Datentyp

integer

Alias
UMLS CUI [1]
C0026265
14. Peripheral vascular disease, lower extremities
Beschreibung

Peripheral vascular disease, lower extremities

Datentyp

integer

Alias
UMLS CUI [1]
C0085096
15. Peripheral vascular disease, other
Beschreibung

Peripheral vascular disease, other

Datentyp

integer

Alias
UMLS CUI [1]
C0085096
16. Paroxysmal atrial fibrillation
Beschreibung

Paroxysmal atrial fibrillation

Datentyp

integer

Alias
UMLS CUI [1]
C0235480
17. Transient ischaemic attack
Beschreibung

Transient ischaemic attack

Datentyp

integer

Alias
UMLS CUI [1]
C0007787
18. Type II diabetes mellitus not requiring pharmacotherapy
Beschreibung

Type II diabetes mellitus not requiring pharmacotherapy

Datentyp

integer

Alias
UMLS CUI [1]
C0948092
Sequence Number
Beschreibung

Sequence Number

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Specific Condition
Beschreibung

Specific Condition

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Modified Term
Beschreibung

Modified Term

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Beschreibung

MedDRA Synonym

Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschreibung

MedDRA lower level term code

Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschreibung

Failed coding

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Status
Beschreibung

Status

Datentyp

text

Alias
UMLS CUI [1]
C0449438
Other cardiovascular conditions
Beschreibung

Other cardiovascular conditions

19.a Sequence Number
Beschreibung

Sequence Number other

Datentyp

text

Alias
UMLS CUI [1]
C2348184
19.b Specific Condition
Beschreibung

Specific Condition other

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
19.c Modified Term
Beschreibung

Modified Term other

Datentyp

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Beschreibung

MedDRA Synonym other

Datentyp

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Beschreibung

MedDRA lower level term code other

Datentyp

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Beschreibung

Failed coding other

Datentyp

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
19.d Status
Beschreibung

Status other

Datentyp

integer

Alias
UMLS CUI [1]
C0205394
Other medical conditions of interest
Beschreibung

Other medical conditions of interest

20. Asthma
Beschreibung

Asthma

Datentyp

integer

Alias
UMLS CUI [1]
C0004096
21. Chronic obstructive pulmonary disease
Beschreibung

Chronic obstructive pulmonary disease

Datentyp

integer

Alias
UMLS CUI [1]
C0024117
If current, requiring oxygen therapy?
Beschreibung

Chronic obstructive pulmonary disease oxygen therapy

Datentyp

integer

Alias
UMLS CUI [1]
C1737722
22. Sleep apnoea
Beschreibung

Sleep apnoea

Datentyp

integer

Alias
UMLS CUI [1]
C0003578
If current, requiring non-invasive ventilation [e.g., CPAP or BiPAP]?
Beschreibung

Sleep apnoea ventilation

Datentyp

boolean

Alias
UMLS CUI [1]
C0003578
23. Renal disease other than diabetic nephropathy
Beschreibung

Renal disease other than diabetic nephropathy

Datentyp

integer

Alias
UMLS CUI [1]
C0022658
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Ähnliche Modelle

Medical conditions of interest GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Cardiovascular conditions of interest
Item
1. Abdominal aortic aneurysm
integer
C0162871 (UMLS CUI [1])
Aortic dissection
Code List
1. Abdominal aortic aneurysm
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
2. Angina pectoris
integer
C0002962 (UMLS CUI [1])
Aortic dissection
Code List
2. Angina pectoris
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
3. Aortic valve disease
integer
C1260873 (UMLS CUI [1])
Aortic dissection
Code List
3. Aortic valve disease
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
4. Atrial flutter
integer
C0004239 (UMLS CUI [1])
Aortic dissection
Code List
4. Atrial flutter
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
5. Carotid artery disease
integer
C0007273 (UMLS CUI [1])
Aortic dissection
Code List
5. Carotid artery disease
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
6. Chronic atrial fibrillation
integer
C0694539 (UMLS CUI [1])
Aortic dissection
Code List
6. Chronic atrial fibrillation
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
7. Congestive heart failure
integer
C0018802 (UMLS CUI [1])
Aortic dissection
Code List
7. Congestive heart failure
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
If current, specify NYHA Functional Class code
integer
C1275491 (UMLS CUI [1])
NYHA Functional Class code
Code List
If current, specify NYHA Functional Class code
CL Item
Class I (1)
C1275491 (UMLS CUI-1)
(Comment:en)
CL Item
Class II (2)
C1275491 (UMLS CUI-1)
(Comment:en)
CL Item
Class III (3)
C1275491 (UMLS CUI-1)
(Comment:en)
CL Item
Class IV (4)
C1275491 (UMLS CUI-1)
(Comment:en)
Item
8. Dyslipidaemia
integer
C0242339 (UMLS CUI [1])
Aortic dissection
Code List
8. Dyslipidaemia
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
9. Hypercholesterolaemia
integer
C0020443 (UMLS CUI [1])
Aortic dissection
Code List
9. Hypercholesterolaemia
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
10. Hypertriglyceridaemia
integer
C0020557 (UMLS CUI [1])
Aortic dissection
Code List
10. Hypertriglyceridaemia
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
11. Low HDL cholesterol
integer
C0151691 (UMLS CUI [1])
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
C0020538 (UMLS CUI [1])
Aortic dissection
Code List
12. Hypertension
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
13. Mitral valve disease
integer
C0026265 (UMLS CUI [1])
Aortic dissection
Code List
13. Mitral valve disease
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
14. Peripheral vascular disease, lower extremities
integer
C0085096 (UMLS CUI [1])
Aortic dissection
Code List
14. Peripheral vascular disease, lower extremities
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
15. Peripheral vascular disease, other
integer
C0085096 (UMLS CUI [1])
Aortic dissection
Code List
15. Peripheral vascular disease, other
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
16. Paroxysmal atrial fibrillation
integer
C0235480 (UMLS CUI [1])
Aortic dissection
Code List
16. Paroxysmal atrial fibrillation
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
17. Transient ischaemic attack
integer
C0007787 (UMLS CUI [1])
Aortic dissection
Code List
17. Transient ischaemic attack
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
18. Type II diabetes mellitus not requiring pharmacotherapy
integer
C0948092 (UMLS CUI [1])
Aortic dissection
Code List
18. Type II diabetes mellitus not requiring pharmacotherapy
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Item Group
Other cardiovascular conditions
Sequence Number other
Item
19.a Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Condition other
Item
19.b Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Modified Term other
Item
19.c Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym other
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code other
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding other
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
19.d Status
integer
C0205394 (UMLS CUI [1])
Status other
Code List
19.d Status
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
Item Group
Other medical conditions of interest
Item
20. Asthma
integer
C0004096 (UMLS CUI [1])
Aortic dissection
Code List
20. Asthma
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
21. Chronic obstructive pulmonary disease
integer
C0024117 (UMLS CUI [1])
Aortic dissection
Code List
21. Chronic obstructive pulmonary disease
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Item
If current, requiring oxygen therapy?
integer
C1737722 (UMLS CUI [1])
Aortic dissection
Code List
If current, requiring oxygen therapy?
CL Item
Yes (1)
CL Item
No (0)
Item
22. Sleep apnoea
integer
C0003578 (UMLS CUI [1])
Aortic dissection
Code List
22. Sleep apnoea
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
Sleep apnoea ventilation
Item
If current, requiring non-invasive ventilation [e.g., CPAP or BiPAP]?
boolean
C0003578 (UMLS CUI [1])
Item
23. Renal disease other than diabetic nephropathy
integer
C0022658 (UMLS CUI [1])
Aortic dissection
Code List
23. Renal disease other than diabetic nephropathy
CL Item
Past (2)
C1444637 (UMLS CUI-1)
(Comment:en)
CL Item
Current (1)
C0521116 (UMLS CUI-1)
(Comment:en)
CL Item
No Medical Condition (5)
C1699700 (UMLS CUI-1)
(Comment:en)
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