ID

26097

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: Other endpoints - Repeating form (Scheduled visits)

Stichworte

Versionen (3)
  1. 09.10.17 09.10.17 -
  2. 23.10.17 23.10.17 -
  3. 03.01.18 03.01.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

9. Oktober 2017

DOI

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

Englisch

Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
Other endpoints
Beschreibung

Other endpoints

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

Select all that apply

Datentyp

boolean

If limb amputation: [F01] Toes
Beschreibung

Select all that apply

Datentyp

boolean

If limb amputation: [F02] Foot
Beschreibung

Select all that apply

Datentyp

boolean

If limb amputation: [F03] Below knee
Beschreibung

Select all that apply

Datentyp

boolean

If limb amputation: [F04] Above knee
Beschreibung

Select all that apply

Datentyp

boolean

If limb amputation: [F05] Upper extremity
Beschreibung

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

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

non-coronary revascularisation Peripheral arterial bypass surgery

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

If peripheral arterial bypass surgery: [G03] Axillobifemoral
Beschreibung

Select all that apply

Datentyp

boolean

If peripheral arterial bypass surgery: [OT] Other
Beschreibung

Select all that apply

Datentyp

boolean

If other peripheral arterial bypass surgery, specify
Beschreibung

Peripheral arterial bypass surgery Other, specification

Datentyp

text

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

Select all that apply

Datentyp

boolean

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

Percutaneous peripheral interventions stenting

Datentyp

text

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

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

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

Select all that apply

Datentyp

boolean

2. Date event met endpoint criteria
Beschreibung

Date event met endpoint criteria

Datentyp

date

CEC Status
Beschreibung

CEC Status

3. CV event number
Beschreibung

[hidden] Item is not required

Datentyp

text

4. Adverse event reference identifier
Beschreibung

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.

Datentyp

text

5. Adverse event term
Beschreibung

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

Datentyp

text

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Ähnliche Modelle

Other endpoints GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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