ID

26712

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: Other endpoints - Repeating form (Scheduled visits)

Keywords

Versions (3)
  1. 10/9/17 10/9/17 -
  2. 10/23/17 10/23/17 -
  3. 1/3/18 1/3/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 23, 2017

DOI

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License

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

English

Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Other endpoints
Description

Other endpoints

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

Select all that apply

Data type

boolean

If limb amputation: [F01] Toes
Description

Select all that apply

Data type

boolean

If limb amputation: [F02] Foot
Description

Select all that apply

Data type

boolean

If limb amputation: [F03] Below knee
Description

Select all that apply

Data type

boolean

If limb amputation: [F04] Above knee
Description

Select all that apply

Data type

boolean

If limb amputation: [F05] Upper extremity
Description

Select all that apply

Data type

boolean

1. Event type: [74] Non-coronary revascularisation
Description

Select all that apply

Data type

boolean

If non-coronary revascularisation: [G01] Peripheral arterial bypass surgery
Description

non-coronary revascularisation Peripheral arterial bypass surgery

Data type

boolean

If peripheral arterial bypass surgery: [G02] Iliac, femoral or popliteal
Description

Select all that apply

Data type

boolean

If peripheral arterial bypass surgery: [G03] Axillobifemoral
Description

Select all that apply

Data type

boolean

If peripheral arterial bypass surgery: [OT] Other
Description

Select all that apply

Data type

boolean

If other peripheral arterial bypass surgery, specify
Description

Peripheral arterial bypass surgery Other, specification

Data type

text

If non-coronary revascularisation: [G04] Percutaneous peripheral interventions [lower extremity]
Description

Select all that apply

Data type

boolean

If percutaneous peripheral interventions [lower extremity]: With stenting?
Description

Percutaneous peripheral interventions stenting

Data type

text

If non-coronary revascularisation: [G06] Carotid endarterectomy
Description

Select all that apply

Data type

boolean

If non-coronary revascularisation: [G07] Carotid stenting
Description

Select all that apply

Data type

boolean

If non-coronary revascularisation: [G08] Aortic aneurysm surgery
Description

Select all that apply

Data type

boolean

If non-coronary revascularisation: [G09] Aortic aneurysm stenting
Description

Select all that apply

Data type

boolean

If non-coronary revascularisation: [G10] Renal artery stenting
Description

Select all that apply

Data type

boolean

If non-coronary revascularisation: [G11] Renal artery surgery for obstructive lesions
Description

Select all that apply

Data type

boolean

If non-coronary revascularisation: [G12] Other percutaneous or surgical revascularisation procedure for obstructive lesion
Description

Select all that apply

Data type

boolean

1. Event type: [75] Hospitalisation for non-coronary ischemic event (except Stroke or TIA)
Description

Select all that apply

Data type

boolean

2. Date event met endpoint criteria
Description

Date event met endpoint criteria

Data type

date

CEC Status
Description

CEC Status

3. CV event number
Description

[hidden] Item is not required

Data type

text

4. Adverse event reference identifier
Description

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.

Data type

text

5. Adverse event term
Description

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

Data type

text

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Similar models

Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Other endpoints
Event type Limb amputation
Item
1. Event type: [73] Limb amputation due to vascular causes
boolean
Event type Limb amputation toes
Item
If limb amputation: [F01] Toes
boolean
Event type Limb amputation Foot
Item
If limb amputation: [F02] Foot
boolean
Event type Limb amputation Below knee
Item
If limb amputation: [F03] Below knee
boolean
Event type Limb amputation Above knee
Item
If limb amputation: [F04] Above knee
boolean
Event type Limb amputation Upper extremity
Item
If limb amputation: [F05] Upper extremity
boolean
Event type Non-coronary revascularisation
Item
1. Event type: [74] Non-coronary revascularisation
boolean
non-coronary revascularisation Peripheral arterial bypass surgery
Item
If non-coronary revascularisation: [G01] Peripheral arterial bypass surgery
boolean
Peripheral arterial bypass surgery Iliac, femoral or popliteal
Item
If peripheral arterial bypass surgery: [G02] Iliac, femoral or popliteal
boolean
Peripheral arterial bypass surgery Axillobifemoral
Item
If peripheral arterial bypass surgery: [G03] Axillobifemoral
boolean
Peripheral arterial bypass surgery Other
Item
If peripheral arterial bypass surgery: [OT] Other
boolean
Peripheral arterial bypass surgery Other, specification
Item
If other peripheral arterial bypass surgery, specify
text
non-coronary revascularisation Percutaneous peripheral interventions
Item
If non-coronary revascularisation: [G04] Percutaneous peripheral interventions [lower extremity]
boolean
Item
If percutaneous peripheral interventions [lower extremity]: With stenting?
text
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
non-coronary revascularisation Carotid stenting
Item
If non-coronary revascularisation: [G07] Carotid stenting
boolean
non-coronary revascularisation Aortic aneurysm surgery
Item
If non-coronary revascularisation: [G08] Aortic aneurysm surgery
boolean
non-coronary revascularisation Aortic aneurysm stenting
Item
If non-coronary revascularisation: [G09] Aortic aneurysm stenting
boolean
non-coronary revascularisation Renal artery stenting
Item
If non-coronary revascularisation: [G10] Renal artery stenting
boolean
non-coronary revascularisation Renal artery surgery for obstructive lesions
Item
If non-coronary revascularisation: [G11] Renal artery surgery for obstructive lesions
boolean
non-coronary revascularisation Other
Item
If non-coronary revascularisation: [G12] Other percutaneous or surgical revascularisation procedure for obstructive lesion
boolean
Event type Hospitalisation for non-coronary ischemic event
Item
1. Event type: [75] Hospitalisation for non-coronary ischemic event (except Stroke or TIA)
boolean
Date event met endpoint criteria
Item
2. Date event met endpoint criteria
date
Item Group
CEC Status
CV event number
Item
3. CV event number
text
Adverse event reference identifier
Item
4. Adverse event reference identifier
text
Adverse event term
Item
5. Adverse event term
text
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