ID

26706

Beschrijving

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: Endpoint death

Trefwoorden

Versies (6)
  1. 05-10-17 05-10-17 -
  2. 05-10-17 05-10-17 -
  3. 05-10-17 05-10-17 -
  4. 16-10-17 16-10-17 -
  5. 23-10-17 23-10-17 -
  6. 03-01-18 03-01-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

23 oktober 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Endpoint death GSK study Chronic Coronary Heart Disease NCT00799903

Engels

Endpoint death GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren  
Investigator section
Beschrijving

Investigator section

1. Date of death
Beschrijving

Date of death

Datatype

date

1. Time of death
Beschrijving

Time of death

Datatype

time

2. Cause of Death
Beschrijving

Cause of Death

Datatype

integer

If cardiovascular, select one
Beschrijving

Cardiovascular cause of death specification

Datatype

integer

If sudden death, select one
Beschrijving

sudden death specification

Datatype

text

If other vascular cause of death, select one
Beschrijving

other vascular cause of death

Datatype

text

If other "other vascular cause of death", specify
Beschrijving

Specify in case of "other vascular cause of death" other than pulmonary embolism or peripheral arterial disease.

Datatype

text

3. Was autopsy performed?
Beschrijving

If yes, include findings in narrative

Datatype

boolean

4. Provide narrative
Beschrijving

narrative autopsy

Datatype

text

5. Date documents sent to CEC Document Group
Beschrijving

Date documents sent to CEC Document Group

Datatype

date

CEC Section
Beschrijving

CEC Section

6. Adjudication
Beschrijving

[hidden]

Datatype

integer

If cardiovascular death - CHD, select one
Beschrijving

cardiovascular death CHD

Datatype

text

If sudden death, select one
Beschrijving

Sudden death

Datatype

integer

If other cardiovascular death - CHD, specify
Beschrijving

other cardiovascular death - CHD specification

Datatype

text

If death of unknown origin, select one
Beschrijving

death of unknown origin

Datatype

integer

If cardiovascular death - Non-CHD, select one
Beschrijving

cardiovascular death - Non-CHD

Datatype

integer

If other vascular cause of death, select one
Beschrijving

other vascular cause of death adjudication

Datatype

text

If other "other vascular cause of death", specify
Beschrijving

Specify in case of "other vascular cause of death" other than pulmonary embolism or peripheral arterial disease.

Datatype

text

If non-cardiovascular death, select one
Beschrijving

non-cardiovascular death

Datatype

text

If other non-cardiovascular death, specify
Beschrijving

other non-cardiovascular death specification

Datatype

text

7. Was this event related to a stent thrombosis?
Beschrijving

[hidden]

Datatype

text

8. Date of adjudication
Beschrijving

[hidden]

Datatype

date

CEC Status
Beschrijving

CEC Status

9. Trigger number
Beschrijving

[hidden]

Datatype

text

10. CEC Status
Beschrijving

[read-only]

Datatype

integer

11. Date of status change
Beschrijving

[read-only]

Datatype

date

12. Physician review #1: Physician
Beschrijving

[hidden]

Datatype

integer

12. Physician review #1: Date sent to reviewer
Beschrijving

[hidden]

Datatype

date

12. Physician review #1: Date received from reviewer
Beschrijving

[hidden]

Datatype

date

12. Physician review #2: Physician
Beschrijving

[hidden]

Datatype

integer

12. Physician review #2: Date sent to reviewer
Beschrijving

[hidden]

Datatype

date

12. Physician review #2: Date received from reviewer
Beschrijving

[hidden]

Datatype

date

14. CEC Coordinator comments
Beschrijving

[hidden]

Datatype

text

15. CV event number
Beschrijving

[hidden]

Datatype

text

16. Adverse event reference identifier
Beschrijving

Use SAE Sequence number from the corresponding SAE form (the last item on the form, in the "Non-Clinical" section) [hidden].

Datatype

text

17. Adverse event term
Beschrijving

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

Datatype

text

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Endpoint death GSK study Chronic Coronary Heart Disease NCT00799903

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Investigator section
Date of death
Item
1. Date of death
date
Time of death
Item
1. Time of death
time
Item
2. Cause of Death
integer
other vascular cause of death
Code List
2. Cause of Death
CL Item
Pulmonary embolism (1)
CL Item
Peripheral arterial disease (46)
CL Item
Other (OT)
Item
If cardiovascular, select one
integer
Adjudication
Code List
If cardiovascular, select one
CL Item
Cardiovascular death - CHD (77)
CL Item
Cardiovascular death - Non-CHD (78)
CL Item
Non-cardiovascular death (32)
Item
If sudden death, select one
text
cardiovascular death CHD
Code List
If sudden death, 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 other vascular cause of death, select one
text
other vascular cause of death
Code List
If other vascular cause of death, select one
CL Item
Pulmonary embolism (1)
CL Item
Peripheral arterial disease (46)
CL Item
Other (OT)
other vascular cause of death specification
Item
If other "other vascular cause of death", specify
text
autopsy
Item
3. Was autopsy performed?
boolean
narrative autopsy
Item
4. Provide narrative
text
Date documents sent to CEC Document Group
Item
5. Date documents sent to CEC Document Group
date
Item Group
CEC Section
Item
6. Adjudication
integer
Adjudication
Code List
6. 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 sudden death, select one
integer
Sudden death
Code List
If sudden death, select one
CL Item
Witnessed (42)
CL Item
Unwitnessed (43)
other cardiovascular death - CHD specification
Item
If other cardiovascular death - CHD, specify
text
Item
If death of unknown origin, select one
integer
death of unknown origin
Code List
If 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
integer
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 cause of death, select one
text
other vascular cause of death
Code List
If other vascular cause of death, select one
CL Item
Pulmonary embolism (1)
CL Item
Peripheral arterial disease (46)
CL Item
Other (OT)
other vascular cause of death specification adjudication
Item
If other "other vascular cause of death", specify
text
Item
If non-cardiovascular death, select one
text
non-cardiovascular death
Code List
If non-cardiovascular death, select one
CL Item
Hemorrhage (58)
CL Item
Neoplasm/cancer (59)
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)
other non-cardiovascular death specification
Item
If other non-cardiovascular death, specify
text
Item
7. Was this event related to a stent thrombosis?
text
relation to stent thrombosis
Code List
7. 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
8. Date of adjudication
date
Item Group
CEC Status
Trigger number
Item
9. Trigger number
text
Item
10. CEC Status
integer
CEC Status
Code List
10. 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
11. Date of status change
date
Item
12. Physician review #1: Physician
integer
Physician review 1 Physician
Code List
12. 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
4 (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
4 (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
12. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
12. Physician review #1: Date received from reviewer
date
Item
12. Physician review #2: Physician
integer
Physician review 1 Physician
Code List
12. 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
4 (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
4 (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
12. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
12. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
14. CEC Coordinator comments
text
CV event number
Item
15. CV event number
text
Adverse event reference identifier
Item
16. Adverse event reference identifier
text
Adverse event term
Item
17. Adverse event term
text
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