ID

26344

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: CEC - Death

Stichworte

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Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. Oktober 2017

DOI

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Creative Commons BY-NC 3.0
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CEC - Death GSK study Chronic Coronary Heart Disease NCT00799903

Englisch

CEC - Death GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare  
CEC - Death
Beschreibung

CEC - Death

1. Date of death
Beschreibung

Date of death

Datentyp

date

1. Time of death
Beschreibung

Time of death

Datentyp

time

Death - CEC Section
Beschreibung

Death - CEC Section

2. Adjudication
Beschreibung

[hidden]

Datentyp

text

If cardiovascular death - CHD, select one
Beschreibung

cardiovascular death - CHD

Datentyp

text

If [76] sudden death, select one
Beschreibung

sudden death

Datentyp

integer

If [OT] other, specify
Beschreibung

Cardiovascular death - CHD other specification

Datentyp

text

If [33] death of unknown origin, select one
Beschreibung

death of unknown origin

Datentyp

integer

If cardiovascular death - Non-CHD, select one
Beschreibung

cardiovascular death - Non-CHD

Datentyp

text

If other vascular causes of death, select one
Beschreibung

other vascular causes of death

Datentyp

text

If [OT] other, specify
Beschreibung

Cardiovascular death - Non-CHD other speicification

Datentyp

text

If non-cardiovascular death, select one
Beschreibung

non-cardiovascular death

Datentyp

text

If [OT] other, specify
Beschreibung

non-cardiovascular death other specification

Datentyp

text

3. Was this event related to a stent thrombosis?
Beschreibung

[hidden]

Datentyp

text

4. Date of adjudication
Beschreibung

[hidden]

Datentyp

date

CEC STATUS
Beschreibung

CEC STATUS

5. Trigger number
Beschreibung

[hidden]

Datentyp

text

6. CEC Status
Beschreibung

[read-only]

Datentyp

integer

7. Date of status change
Beschreibung

[read-only]

Datentyp

date

8. Physician review #1: Physician
Beschreibung

[hidden]

Datentyp

integer

8. Physician review #1: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

8. Physician review #1: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

9. Physician review #2: Physician
Beschreibung

[hidden]

Datentyp

integer

9. Physician review #2: Date sent to reviewer
Beschreibung

[hidden]

Datentyp

date

9. Physician review #2: Date received from reviewer
Beschreibung

[hidden]

Datentyp

date

10. CEC Coordinator comments
Beschreibung

[hidden]

Datentyp

text

11. CV event number
Beschreibung

[hidden]

Datentyp

text

12. 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]

Datentyp

text

13. Adverse event term
Beschreibung

Copy Serious Adverse Event term from corresponding SAE form [hidden]

Datentyp

text

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Ähnliche Modelle

CEC - Death GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
CEC - Death
Date of death
Item
1. Date of death
date
Time of death
Item
1. Time of death
time
Item Group
Death - CEC Section
Item
2. Adjudication
text
Adjudication
Code List
2. Adjudication
CL Item
Cardiovascular death - CHD (77)
CL Item
Cardiovascular death - Non-CHD (78)
CL Item
Non-cardiovascular death (32)
Item
If cardiovascular death - CHD, select one
text
cardiovascular death - CHD
Code List
If cardiovascular death - CHD, select one
CL Item
Sudden death (76)
CL Item
Fatal MI (34)
CL Item
Arrhythmia (ventricular fibrillation or other lethal arrhythmias without known secondary cause) (48)
CL Item
Congestive heart failure/shock (49)
CL Item
Other (OT)
CL Item
Death of unknown origin (33)
Item
If [76] sudden death, select one
integer
sudden death
Code List
If [76] sudden death, select one
CL Item
Witnessed (42)
CL Item
Unwitnessed (43)
Cardiovascular death - CHD other specification
Item
If [OT] other, specify
text
Item
If [33] death of unknown origin, select one
integer
death of unknown origin
Code List
If [33] death of unknown origin, select one
CL Item
Limited or no source documents (56)
CL Item
Adequate source documents to make the call for an Unknown death (57)
Item
If cardiovascular death - Non-CHD, select one
text
cardiovascular death - Non-CHD
Code List
If cardiovascular death - Non-CHD, select one
CL Item
Other vascular causes of death (51)
CL Item
Fatal stroke (45)
CL Item
Complication of a cardiovascular procedure (47)
Item
If other vascular causes of death, select one
text
other vascular causes of death
Code List
If other vascular causes of death, select one
CL Item
Pulmonary embolism (1)
CL Item
Peripheral arterial disease (46)
CL Item
Other (OT)
Cardiovascular death - Non-CHD other speicification
Item
If [OT] other, specify
text
Item
If non-cardiovascular death, select one
text
non-cardiovascular death
Code List
If non-cardiovascular death, select one
CL Item
[58] Hemorrhage ([58] Hemorrhage)
CL Item
[59] Neoplasm/cancer ([59] Neoplasm/cancer)
CL Item
Trauma (52)
CL Item
Infection/sepsis (60)
CL Item
Post non-cardiovascular surgery (53)
CL Item
Pulmonary (61)
CL Item
Suicide (54)
CL Item
Other (OT)
non-cardiovascular death other specification
Item
If [OT] other, specify
text
Item
3. Was this event related to a stent thrombosis?
text
event related to stent thrombosis
Code List
3. Was this event related to a stent thrombosis?
CL Item
Definite (DF)
CL Item
Probable (PB)
CL Item
No (N)
CL Item
Unknown (U)
Date of adjudication
Item
4. Date of adjudication
date
Item Group
CEC STATUS
Trigger number
Item
5. Trigger number
text
Item
6. CEC Status
integer
CEC Status
Code List
6. CEC Status
CL Item
New (1)
CL Item
Coordinator Screen check (2)
CL Item
Hold (3)
CL Item
Ready for review (4)
CL Item
In Phase I review (5)
CL Item
Queried (InForm) (6)
CL Item
Additional documents required (7)
CL Item
In Phase II committee (8)
CL Item
Data change (9)
CL Item
Re-Review (10)
CL Item
Completed event (11)
CL Item
No event to adjudicate (12)
CL Item
QC Random sample (13)
CL Item
In Translation (14)
Date of status change
Item
7. Date of status change
date
Item
8. Physician review #1: Physician
integer
Physician review 1
Code List
8. Physician review #1: Physician
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33 (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47 (47)
CL Item
48 (48)
CL Item
49 (49)
CL Item
50 (50)
Physician review 1 Date sent to reviewer
Item
8. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
8. Physician review #1: Date received from reviewer
date
Item
9. Physician review #2: Physician
integer
Physician review 1
Code List
9. Physician review #2: Physician
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
CL Item
13 (13)
CL Item
14 (14)
CL Item
15 (15)
CL Item
16 (16)
CL Item
17 (17)
CL Item
18 (18)
CL Item
19 (19)
CL Item
20 (20)
CL Item
21 (21)
CL Item
22 (22)
CL Item
23 (23)
CL Item
24 (24)
CL Item
25 (25)
CL Item
26 (26)
CL Item
27 (27)
CL Item
28 (28)
CL Item
29 (29)
CL Item
30 (30)
CL Item
31 (31)
CL Item
32 (32)
CL Item
33 (33)
CL Item
34 (34)
CL Item
35 (35)
CL Item
36 (36)
CL Item
37 (37)
CL Item
38 (38)
CL Item
39 (39)
CL Item
40 (40)
CL Item
41 (41)
CL Item
42 (42)
CL Item
43 (43)
CL Item
44 (44)
CL Item
45 (45)
CL Item
46 (46)
CL Item
47 (47)
CL Item
48 (48)
CL Item
49 (49)
CL Item
50 (50)
Physician review 2 Date sent to reviewer
Item
9. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
9. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
10. CEC Coordinator comments
text
CV event number
Item
11. CV event number
text
Adverse event reference identifier
Item
12. Adverse event reference identifier
text
Adverse event term
Item
13. Adverse event term
text
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