ID

28317

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: ECG Evidence of myocardial ischemia/infarction - 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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ECG Evidence of myocardial ischemia/infarction GSK study Chronic Coronary Heart Disease NCT00799903

Inglés

ECG Evidence of myocardial ischemia/infarction GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios  
ECG Evidence of myocardial ischemia/infarction
Descripción

ECG Evidence of myocardial ischemia/infarction

1. Date of ECG
Descripción

Date of ECG

Tipo de datos

date

Alias
UMLS CUI [1]
C2826640
1. Time of ECG
Descripción

Time is optional.

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
2. ECG evidence of myocardial ischemia/infarction
Descripción

ECG evidence of myocardial ischemia/infarction

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0151744
If clinically significant change from previous ECG: [1] New ST-segment depression
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520887
If new ST-segment depression, select one
Descripción

new ST-segment depression

Tipo de datos

text

Alias
UMLS CUI [1]
C0520887
If clinically significant change from previous ECG: [2] New ST-segment elevation
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520886
If new ST-segment elevation, select one
Descripción

New ST-segment elevation

Tipo de datos

text

Alias
UMLS CUI [1]
C0520886
If clinically significant change from previous ECG: [3] New T wave changes
Descripción

Select all that apply

Tipo de datos

boolean

If new T wave changes, select one
Descripción

New T wave changes

Tipo de datos

text

Alias
UMLS CUI [1]
C0429103
If clinically significant change from previous ECG: [4] New left bundle branch block
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023211
If clinically significant change from previous ECG: [5] New pathological Q waves
Descripción

Select all that apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023211
If new pathological Q waves, select one
Descripción

New pathological Q waves

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C1521733
3. Date ECG sent to CEC
Descripción

Date ECG sent to CEC

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0011008
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Similar models

ECG Evidence of myocardial ischemia/infarction GSK study Chronic Coronary Heart Disease NCT00799903

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
ECG Evidence of myocardial ischemia/infarction
Date of ECG
Item
1. Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
1. Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
2. ECG evidence of myocardial ischemia/infarction
integer
C0027051 (UMLS CUI [1,1])
C0151744 (UMLS CUI [1,2])
ECG evidence of myocardial ischemia/infarction
Code List
2. ECG evidence of myocardial ischemia/infarction
CL Item
Clinically significant change from previous ECG (8)
CL Item
No change or insignificant change from previous ECG (3)
New ST-segment depression ECG
Item
If clinically significant change from previous ECG: [1] New ST-segment depression
boolean
C0520887 (UMLS CUI [1])
Item
If new ST-segment depression, select one
text
C0520887 (UMLS CUI [1])
new ST-segment depression
Code List
If new ST-segment depression, select one
CL Item
Anterior (1)
C0205094 (UMLS CUI-1)
(Comment:en)
CL Item
Inferior (2)
C0542339 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
New ST-segment elevation ECG
Item
If clinically significant change from previous ECG: [2] New ST-segment elevation
boolean
C0520886 (UMLS CUI [1])
Item
If new ST-segment elevation, select one
text
C0520886 (UMLS CUI [1])
new ST-segment depression
Code List
If new ST-segment elevation, select one
CL Item
Anterior (1)
C0205094 (UMLS CUI-1)
(Comment:en)
CL Item
Inferior (2)
C0542339 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
New T wave changes ECG
Item
If clinically significant change from previous ECG: [3] New T wave changes
boolean
Item
If new T wave changes, select one
text
C0429103 (UMLS CUI [1])
new ST-segment depression
Code List
If new T wave changes, select one
CL Item
Anterior (1)
C0205094 (UMLS CUI-1)
(Comment:en)
CL Item
Inferior (2)
C0542339 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
New left bundle branch block ECG
Item
If clinically significant change from previous ECG: [4] New left bundle branch block
boolean
C0023211 (UMLS CUI [1])
New left bundle branch block ECG
Item
If clinically significant change from previous ECG: [5] New pathological Q waves
boolean
C0023211 (UMLS CUI [1])
Item
If new pathological Q waves, select one
text
C1305738 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])
new ST-segment depression
Code List
If new pathological Q waves, select one
CL Item
Anterior (1)
C0205094 (UMLS CUI-1)
(Comment:en)
CL Item
Inferior (2)
C0542339 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
Date ECG sent to CEC
Item
3. Date ECG sent to CEC
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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