ID

28314

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: Endpoint death

Keywords

Versions (6)
  1. 10/5/17 10/5/17 -
  2. 10/5/17 10/5/17 -
  3. 10/5/17 10/5/17 -
  4. 10/16/17 10/16/17 -
  5. 10/23/17 10/23/17 -
  6. 1/3/18 1/3/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 3, 2018

DOI

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License

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

English

Endpoint death GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
Investigator section
Description

Investigator section

1. Date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
1. Time of death
Description

Time of death

Data type

time

Alias
UMLS CUI [1]
C1301931
2. Cause of Death
Description

Cause of Death

Data type

text

Alias
UMLS CUI [1]
C0007465
If cardiovascular, select one
Description

Cardiovascular cause of death specification

Data type

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0007465
If sudden death, select one
Description

sudden death specification

Data type

text

Alias
UMLS CUI [1]
C0011071
If other vascular cause of death, select one
Description

other vascular cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
If other "other vascular cause of death", specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C2348235
3. Was autopsy performed?
Description

If yes, include findings in narrative

Data type

boolean

Alias
UMLS CUI [1]
C0004398
4. Provide narrative
Description

narrative autopsy

Data type

text

Alias
UMLS CUI [1]
C0004398
5. Date documents sent to CEC Document Group
Description

Date documents sent to CEC Document Group

Data type

date

Alias
UMLS CUI [1]
C2986012
CEC Section
Description

CEC Section

6. Adjudication
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C3260278
If cardiovascular death - CHD, select one
Description

cardiovascular death CHD

Data type

text

Alias
UMLS CUI [1]
C0010068
If sudden death, select one
Description

Sudden death

Data type

integer

Alias
UMLS CUI [1]
C0011071
If other cardiovascular death - CHD, specify
Description

other cardiovascular death - CHD specification

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C2348235
If death of unknown origin, select one
Description

death of unknown origin

Data type

integer

Alias
UMLS CUI [1]
C0277589
If cardiovascular death - Non-CHD, select one
Description

cardiovascular death - Non-CHD

Data type

integer

Alias
UMLS CUI [1]
C0010068
If other vascular cause of death, select one
Description

other vascular cause of death adjudication

Data type

text

Alias
UMLS CUI [1]
C0007465
If other "other vascular cause of death", specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0007465
If non-cardiovascular death, select one
Description

non-cardiovascular death

Data type

text

Alias
UMLS CUI [1]
C0007465
If other non-cardiovascular death, specify
Description

other non-cardiovascular death specification

Data type

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C2348235
7. Was this event related to a stent thrombosis?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1536080
8. Date of adjudication
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C3260278
CEC Status
Description

CEC Status

9. Trigger number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2736071
10. CEC Status
Description

[read-only]

Data type

integer

11. Date of status change
Description

[read-only]

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0443172
12. Physician review #1: Physician
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C2826892
12. Physician review #1: Date sent to reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C1515023
UMLS CUI [1,2]
C0011008
12. Physician review #1: Date received from reviewer
Description

[hidden]

Data type

date

12. Physician review #2: Physician
Description

[hidden]

Data type

integer

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

[hidden]

Data type

date

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

[hidden]

Data type

date

14. CEC Coordinator comments
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0947611
15. CV event number
Description

[hidden]

Data type

text

16. 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].

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348585
17. Adverse event term
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C2826934
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Similar models

Endpoint death GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Investigator section
Date of death
Item
1. Date of death
date
C1148348 (UMLS CUI [1])
Time of death
Item
1. Time of death
time
C1301931 (UMLS CUI [1])
Item
2. Cause of Death
text
C0007465 (UMLS CUI [1])
other vascular cause of death
Code List
2. Cause of Death
CL Item
Pulmonary embolism (1)
C0034065 (UMLS CUI-1)
(Comment:en)
CL Item
Peripheral arterial disease (46)
C1704436 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
Item
If cardiovascular, select one
integer
C2348235 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Adjudication
Code List
If cardiovascular, select one
CL Item
Cardiovascular death - CHD (77)
C0010068 (UMLS CUI-1)
(Comment:en)
CL Item
Cardiovascular death - Non-CHD (78)
C0007465 (UMLS CUI-1)
C0010068 (UMLS CUI-2)
(Comment:en)
CL Item
Non-cardiovascular death (32)
(Comment:en)
Item
If sudden death, select one
text
C0011071 (UMLS CUI [1])
cardiovascular death CHD
Code List
If sudden death, select one
CL Item
Sudden death (76)
C0011071 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal MI (34)
C0027051 (UMLS CUI-1)
(Comment:en)
CL Item
Arrhythmia (ventricular fibrillation or other lethal arrhythmias without known secondary cause) (48)
C0003811 (UMLS CUI-1)
(Comment:en)
CL Item
Congestive heart failure/shock (49)
C0018802 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
CL Item
Death of unknown origin (33)
C0277589 (UMLS CUI-1)
(Comment:en)
Item
If other vascular cause of death, select one
text
C0007465 (UMLS CUI [1])
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
C0007465 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
autopsy
Item
3. Was autopsy performed?
boolean
C0004398 (UMLS CUI [1])
narrative autopsy
Item
4. Provide narrative
text
C0004398 (UMLS CUI [1])
Date documents sent to CEC Document Group
Item
5. Date documents sent to CEC Document Group
date
C2986012 (UMLS CUI [1])
Item Group
CEC Section
Item
6. Adjudication
integer
C3260278 (UMLS CUI [1])
Adjudication
Code List
6. Adjudication
CL Item
Cardiovascular death - CHD (77)
C0010068 (UMLS CUI-1)
(Comment:en)
CL Item
Cardiovascular death - Non-CHD (78)
C0007465 (UMLS CUI-1)
C0010068 (UMLS CUI-2)
(Comment:en)
CL Item
Non-cardiovascular death (32)
(Comment:en)
Item
If cardiovascular death - CHD, select one
text
C0010068 (UMLS CUI [1])
cardiovascular death CHD
Code List
If cardiovascular death - CHD, select one
CL Item
Sudden death (76)
C0011071 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal MI (34)
C0027051 (UMLS CUI-1)
(Comment:en)
CL Item
Arrhythmia (ventricular fibrillation or other lethal arrhythmias without known secondary cause) (48)
C0003811 (UMLS CUI-1)
(Comment:en)
CL Item
Congestive heart failure/shock (49)
C0018802 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
CL Item
Death of unknown origin (33)
C0277589 (UMLS CUI-1)
(Comment:en)
Item
If sudden death, select one
integer
C0011071 (UMLS CUI [1])
Sudden death
Code List
If sudden death, select one
CL Item
Witnessed (42)
C2924291 (UMLS CUI-1)
(Comment:en)
CL Item
Unwitnessed (43)
C0859934 (UMLS CUI-1)
(Comment:en)
other cardiovascular death - CHD specification
Item
If other cardiovascular death - CHD, specify
text
C0007465 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
If death of unknown origin, select one
integer
C0277589 (UMLS CUI [1])
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
C0010068 (UMLS CUI [1])
cardiovascular death - Non-CHD
Code List
If cardiovascular death - Non-CHD, select one
CL Item
Other vascular causes of death (51)
C0007465 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal stroke (45)
C0038454 (UMLS CUI-1)
(Comment:en)
CL Item
Complication of a cardiovascular procedure (47)
C0274311 (UMLS CUI-1)
C0205404 (UMLS CUI-2)
(Comment:en)
Item
If other vascular cause of death, select one
text
C0007465 (UMLS CUI [1])
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
C2348235 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Item
If non-cardiovascular death, select one
text
C0007465 (UMLS CUI [1])
non-cardiovascular death
Code List
If non-cardiovascular death, select one
CL Item
Hemorrhage (58)
C0019080 (UMLS CUI-1)
(Comment:en)
CL Item
Neoplasm/cancer (59)
C2939420 (UMLS CUI-1)
(Comment:en)
CL Item
Trauma (52)
C3714660 (UMLS CUI-1)
(Comment:en)
CL Item
Infection/sepsis (60)
C0009450 (UMLS CUI-1)
C0243026 (UMLS CUI-2)
(Comment:en)
CL Item
Post non-cardiovascular surgery (53)
C0231290 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
(Comment:en)
CL Item
Pulmonary (61)
C2709248 (UMLS CUI-1)
(Comment:en)
CL Item
Suicide (54)
C0038661 (UMLS CUI-1)
(Comment:en)
CL Item
Other (OT)
C0205394 (UMLS CUI-1)
(Comment:en)
other non-cardiovascular death specification
Item
If other non-cardiovascular death, specify
text
C0007465 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
7. Was this event related to a stent thrombosis?
text
C1536080 (UMLS CUI [1])
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
C3260278 (UMLS CUI [1])
Item Group
CEC Status
Trigger number
Item
9. Trigger number
text
C2736071 (UMLS CUI [1])
Item
10. CEC Status
integer
CEC Status
Code List
10. CEC Status
CL Item
New (1)
C0205314 (UMLS CUI-1)
(Comment:en)
CL Item
Coordinator Screen check (2)
C1710220 (UMLS CUI-1)
(Comment:en)
CL Item
Hold (3)
C1948035 (UMLS CUI-1)
(Comment:en)
CL Item
Ready for review (4)
C3841913 (UMLS CUI-1)
(Comment:en)
CL Item
In Phase I review (5)
C3166277 (UMLS CUI-1)
(Comment:en)
CL Item
Queried (InForm) (6)
C0683836 (UMLS CUI-1)
(Comment:en)
CL Item
Additional documents required (7)
C0037793 (UMLS CUI-1)
(Comment:en)
CL Item
In Phase II committee (8)
C0282460 (UMLS CUI-1)
(Comment:en)
CL Item
Data change (9)
C0010995 (UMLS CUI-1)
C0392747 (UMLS CUI-2)
(Comment:en)
CL Item
Re-Review (10)
C0205090 (UMLS CUI-1)
(Comment:en)
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
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
12. Physician review #1: Physician
integer
C2826892 (UMLS CUI [1])
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
C1515023 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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
C0947611 (UMLS CUI [1])
CV event number
Item
15. CV event number
text
Adverse event reference identifier
Item
16. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
17. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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