ID

28319

Descripción

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: Other endpoints - Repeating form (Scheduled visits)

Palabras clave

Versiones (3)
  1. 9/10/17 9/10/17 -
  2. 23/10/17 23/10/17 -
  3. 3/1/18 3/1/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de enero de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

Inglés

Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios  
Other endpoints
Descripción

Other endpoints

1. Event type: [73] Limb amputation due to vascular causes
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002689
If limb amputation: [F01] Toes
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337308
If limb amputation: [F02] Foot
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0188605
If limb amputation: [F03] Below knee
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0002689
If limb amputation: [F04] Above knee
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0574835
If limb amputation: [F05] Upper extremity
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1536402
1. Event type: [74] Non-coronary revascularisation
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0543467
If non-coronary revascularisation: [G01] Peripheral arterial bypass surgery
Descripción

non-coronary revascularisation Peripheral arterial bypass surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C3495795
If peripheral arterial bypass surgery: [G02] Iliac, femoral or popliteal
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0190932
If peripheral arterial bypass surgery: [G03] Axillobifemoral
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C3495795
If peripheral arterial bypass surgery: [OT] Other
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C3495795
If other peripheral arterial bypass surgery, specify
Descripción

Peripheral arterial bypass surgery Other, specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C3495795
UMLS CUI [1,3]
C2348235
If non-coronary revascularisation: [G04] Percutaneous peripheral interventions [lower extremity]
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1532338
If percutaneous peripheral interventions [lower extremity]: With stenting?
Descripción

Percutaneous peripheral interventions stenting

Tipo de datos

text

Alias
UMLS CUI [1]
C0522776
If non-coronary revascularisation: [G06] Carotid endarterectomy
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0014099
If non-coronary revascularisation: [G07] Carotid stenting
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0687568
If non-coronary revascularisation: [G08] Aortic aneurysm surgery
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2037604
If non-coronary revascularisation: [G09] Aortic aneurysm stenting
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0585569
If non-coronary revascularisation: [G10] Renal artery stenting
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1322812
If non-coronary revascularisation: [G11] Renal artery surgery for obstructive lesions
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1322812
UMLS CUI [1,2]
C3872566
If non-coronary revascularisation: [G12] Other percutaneous or surgical revascularisation procedure for obstructive lesion
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0543467
1. Event type: [75] Hospitalisation for non-coronary ischemic event (except Stroke or TIA)
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0010068
2. Date event met endpoint criteria
Descripción

Date event met endpoint criteria

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
CEC Status
Descripción

CEC Status

3. CV event number
Descripción

[hidden] Item is not required

Tipo de datos

text

Alias
UMLS CUI [1]
C2826275
4. Adverse event reference identifier
Descripción

Use SAE Sequence number from the corresponding SAE form (the last item on the form, in the "Non-Clinical" section) [hidden]. Item is not required.

Tipo de datos

text

Alias
UMLS CUI [1]
C0877248
5. Adverse event term
Descripción

Copy Serious Adverse Event term from corresponding SAE form [hidden]. Item is not required.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C2826934
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Similar models

Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Other endpoints
Event type Limb amputation
Item
1. Event type: [73] Limb amputation due to vascular causes
boolean
C0002689 (UMLS CUI [1])
Event type Limb amputation toes
Item
If limb amputation: [F01] Toes
boolean
C0337308 (UMLS CUI [1])
Event type Limb amputation Foot
Item
If limb amputation: [F02] Foot
boolean
C0188605 (UMLS CUI [1])
Event type Limb amputation Below knee
Item
If limb amputation: [F03] Below knee
boolean
C0002689 (UMLS CUI [1])
Event type Limb amputation Above knee
Item
If limb amputation: [F04] Above knee
boolean
C0574835 (UMLS CUI [1])
Event type Limb amputation Upper extremity
Item
If limb amputation: [F05] Upper extremity
boolean
C1536402 (UMLS CUI [1])
Event type Non-coronary revascularisation
Item
1. Event type: [74] Non-coronary revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
non-coronary revascularisation Peripheral arterial bypass surgery
Item
If non-coronary revascularisation: [G01] Peripheral arterial bypass surgery
boolean
C0010055 (UMLS CUI [1,1])
C3495795 (UMLS CUI [1,2])
Peripheral arterial bypass surgery Iliac, femoral or popliteal
Item
If peripheral arterial bypass surgery: [G02] Iliac, femoral or popliteal
boolean
C0190932 (UMLS CUI [1])
Peripheral arterial bypass surgery Axillobifemoral
Item
If peripheral arterial bypass surgery: [G03] Axillobifemoral
boolean
C0010055 (UMLS CUI [1,1])
C3495795 (UMLS CUI [1,2])
Peripheral arterial bypass surgery Other
Item
If peripheral arterial bypass surgery: [OT] Other
boolean
C0010055 (UMLS CUI [1,1])
C3495795 (UMLS CUI [1,2])
Peripheral arterial bypass surgery Other, specification
Item
If other peripheral arterial bypass surgery, specify
text
C0010055 (UMLS CUI [1,1])
C3495795 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
non-coronary revascularisation Percutaneous peripheral interventions
Item
If non-coronary revascularisation: [G04] Percutaneous peripheral interventions [lower extremity]
boolean
C0877341 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
Item
If percutaneous peripheral interventions [lower extremity]: With stenting?
text
C0522776 (UMLS CUI [1])
Percutaneous peripheral interventions stenting
Code List
If percutaneous peripheral interventions [lower extremity]: With stenting?
CL Item
Yes (G05)
CL Item
No (-99)
non-coronary revascularisation Carotid endarterectomy
Item
If non-coronary revascularisation: [G06] Carotid endarterectomy
boolean
C0014099 (UMLS CUI [1])
non-coronary revascularisation Carotid stenting
Item
If non-coronary revascularisation: [G07] Carotid stenting
boolean
C0687568 (UMLS CUI [1])
non-coronary revascularisation Aortic aneurysm surgery
Item
If non-coronary revascularisation: [G08] Aortic aneurysm surgery
boolean
C2037604 (UMLS CUI [1])
non-coronary revascularisation Aortic aneurysm stenting
Item
If non-coronary revascularisation: [G09] Aortic aneurysm stenting
boolean
C0585569 (UMLS CUI [1])
non-coronary revascularisation Renal artery stenting
Item
If non-coronary revascularisation: [G10] Renal artery stenting
boolean
C1322812 (UMLS CUI [1])
non-coronary revascularisation Renal artery surgery for obstructive lesions
Item
If non-coronary revascularisation: [G11] Renal artery surgery for obstructive lesions
boolean
C1322812 (UMLS CUI [1,1])
C3872566 (UMLS CUI [1,2])
non-coronary revascularisation Other
Item
If non-coronary revascularisation: [G12] Other percutaneous or surgical revascularisation procedure for obstructive lesion
boolean
C0877341 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Event type Hospitalisation for non-coronary ischemic event
Item
1. Event type: [75] Hospitalisation for non-coronary ischemic event (except Stroke or TIA)
boolean
C0010068 (UMLS CUI [1])
Date event met endpoint criteria
Item
2. Date event met endpoint criteria
date
C0011008 (UMLS CUI [1])
Item Group
CEC Status
CV event number
Item
3. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
4. Adverse event reference identifier
text
C0877248 (UMLS CUI [1])
Adverse event term
Item
5. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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