ID

28403

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: CEC -revascularisation Repeating form (Scheduled visits)

Keywords

Versions (3)
  1. 10/11/17 10/11/17 -
  2. 10/23/17 10/23/17 -
  3. 1/11/18 1/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 11, 2018

DOI

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License

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

English

CEC - revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

1 forms  
CEC - revascularisation
Description

CEC - revascularisation

1. Date of procedure
Description

[hidden]

Data type

date

Alias
UMLS CUI [1]
C2584899
1. Start time of procedure
Description

[hidden]

Data type

time

Alias
UMLS CUI [1,1]
C2700391
UMLS CUI [1,2]
C1301880
2. Revascularisation procedure
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0581603
If PCI - single vessel, select one
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0856737
UMLS CUI [1,2]
C1532338
If PCI - single vessel with stent: C02 Bare metal
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C2825200
UMLS CUI [1,2]
C1532338
UMLS CUI [1,3]
C0856737
If PCI - single vessel with stent (bare metal), indicate number of stents
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C2024081
UMLS CUI [1,2]
C2825200
UMLS CUI [1,3]
C0449788
If PCI - single vessel with stent: C03 Drug-eluting
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0856737
UMLS CUI [1,3]
C1322815
If PCI - single vessel with stent (drug-eluting), indicate number of stents
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C2024081
UMLS CUI [1,2]
C1262327
UMLS CUI [1,3]
C0449788
If PCI - multiple vessels, select one
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0202886
If PCI - multiple vessels with stent: C05 Bare metal
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1]
C2825200
If PCI - multiple vessels with stent (bare metal), indicate number of stents
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C2024081
UMLS CUI [1,2]
C2825200
If PCI - multiple vessels with stent: C06 Drug-eluting
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C0202886
If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C1322815
UMLS CUI [1,2]
C0202886
UMLS CUI [1,3]
C0449788
If CABG: C07 Arterial graft
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1]
C0371564
Number of grafts
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C0371564
UMLS CUI [1,2]
C0237753
If CABG: C08 Saphenous vein graft
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C0729538
UMLS CUI [1,2]
C0010055
Number of grafts
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1,1]
C0729538
UMLS CUI [1,2]
C0010055
UMLS CUI [1,3]
C0237753
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1299991
UMLS CUI [1,2]
C2986546
Urgent coronary revascularisation for myocardial ischemia
Description

Urgent coronary revascularisation for myocardial ischemia

6. Adjudication
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C0680730
If criteria for urgent coronary revscularisation for myocardial ischemia not met, comment
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0948089
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C0543467
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [99] Revascularisation was a treatment for MI
Description

[hidden]

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C1566537
5. Was this event related to a stent thrombosis?
Description

[hidden]

Data type

text

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

[hidden]

Data type

date

Alias
UMLS CUI [1]
C3260278
CEC Status
Description

CEC Status

7. Trigger number
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1444748
8. CEC Status
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C0449438
9. Date of status change
Description

[read-only]

Data type

date

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

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C0184806
10. Physician review #1: Date sent to reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1515023
UMLS CUI [1,4]
C0011008
10. Physician review #1: Date received from reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C0011008
11. Physician review #2: Physician
Description

[hidden]

Data type

integer

Alias
UMLS CUI [1]
C0184806
11. Physician review #2: Date sent to reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1515023
UMLS CUI [1,4]
C0011008
11. Physician review #2: Date received from reviewer
Description

[hidden]

Data type

date

Alias
UMLS CUI [1,1]
C0031831
UMLS CUI [1,2]
C3166277
UMLS CUI [1,3]
C1514756
UMLS CUI [1,4]
C0011008
12. CEC Coordinator comments
Description

[hidden]

Data type

text

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2826275
14. 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
15. 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

CEC - revascularisation GSK study Chronic Coronary Heart Disease NCT00799903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
CEC - revascularisation
Date of procedure
Item
1. Date of procedure
date
C2584899 (UMLS CUI [1])
Start time of procedure
Item
1. Start time of procedure
time
C2700391 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Item
2. Revascularisation procedure
text
C0581603 (UMLS CUI [1])
Revascularisation procedure
Code List
2. Revascularisation procedure
CL Item
PCI - single vessel (CA)
C0856737 (UMLS CUI-1)
C1532338 (UMLS CUI-2)
(Comment:en)
CL Item
PCI - multiple vessels (CC)
C0202886 (UMLS CUI-1)
(Comment:en)
CL Item
CABG (CE)
C0010055 (UMLS CUI-1)
(Comment:en)
CL Item
Revascularisation procedure attempted but not successful (C09)
C0581603 (UMLS CUI-1)
C1272704 (UMLS CUI-2)
(Comment:en)
Item
If PCI - single vessel, select one
text
C0856737 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
PCI single vessel
Code List
If PCI - single vessel, select one
CL Item
without stent (C01)
CL Item
with stent (CB)
PCI single vessel with stent Bare metal
Item
If PCI - single vessel with stent: C02 Bare metal
boolean
C2825200 (UMLS CUI [1,1])
C1532338 (UMLS CUI [1,2])
C0856737 (UMLS CUI [1,3])
number of stents bare metal single vessel
Item
If PCI - single vessel with stent (bare metal), indicate number of stents
integer
C2024081 (UMLS CUI [1,1])
C2825200 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
PCI single vessel with stent Drug-eluting
Item
If PCI - single vessel with stent: C03 Drug-eluting
boolean
C1532338 (UMLS CUI [1,1])
C0856737 (UMLS CUI [1,2])
C1322815 (UMLS CUI [1,3])
number of stents drug-eluting single vessel
Item
If PCI - single vessel with stent (drug-eluting), indicate number of stents
integer
C2024081 (UMLS CUI [1,1])
C1262327 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item
If PCI - multiple vessels, select one
text
C0202886 (UMLS CUI [1])
PCI single vessel
Code List
If PCI - multiple vessels, select one
CL Item
without stent (C04)
C0687568 (UMLS CUI-1)
(Comment:en)
CL Item
with stent (CD)
C0038257 (UMLS CUI-1)
(Comment:en)
PCI multiple vessels with stent Bare metal
Item
If PCI - multiple vessels with stent: C05 Bare metal
boolean
C2825200 (UMLS CUI [1])
number of stents bare metal multiple vessels
Item
If PCI - multiple vessels with stent (bare metal), indicate number of stents
integer
C2024081 (UMLS CUI [1,1])
C2825200 (UMLS CUI [1,2])
PCI multiple vessels with stent Drug-eluting
Item
If PCI - multiple vessels with stent: C06 Drug-eluting
boolean
C1322815 (UMLS CUI [1,1])
C0202886 (UMLS CUI [1,2])
number of stents drug-eluting multiple vessels
Item
If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
integer
C1322815 (UMLS CUI [1,1])
C0202886 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
CABG Arterial graft
Item
If CABG: C07 Arterial graft
boolean
C0371564 (UMLS CUI [1])
CABG arterial graft number
Item
Number of grafts
integer
C0371564 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
CABG Saphenous vein graft
Item
If CABG: C08 Saphenous vein graft
boolean
C0729538 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
CABG Saphenous vein graft number
Item
Number of grafts
integer
C0729538 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
text
C1299991 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
revascularisation of a target lesion from PCI
Code List
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
Urgent coronary revascularisation for myocardial ischemia
Item
6. Adjudication
text
C0680730 (UMLS CUI [1])
Adjudication
Code List
6. Adjudication
CL Item
Urgent coronary revascularisation for myocardial ischemia (70)
CL Item
Does not meet criteria for urgent coronary revscularisation for myocardial ischemia (NC)
criteria for urgent coronary revscularisation for myocardial ischemia not met
Item
If criteria for urgent coronary revscularisation for myocardial ischemia not met, comment
text
C0151744 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])
Non-urgent coronary revascularisation
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Revascularisation was a treatment for MI
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [99] Revascularisation was a treatment for MI
boolean
C0013216 (UMLS CUI [1,1])
C1566537 (UMLS CUI [1,2])
Item
5. Was this event related to a stent thrombosis?
text
C1536080 (UMLS CUI [1])
Was this event related to a stent thrombosis?
Code List
5. 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
6. Date of adjudication
date
C3260278 (UMLS CUI [1])
Item Group
CEC Status
Trigger number
Item
7. Trigger number
text
C1444748 (UMLS CUI [1])
Item
8. CEC Status
integer
C0449438 (UMLS CUI [1])
CEC Status
Code List
8. 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
9. Date of status change
date
C0011008 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
10. Physician review #1: Physician
integer
C0184806 (UMLS CUI [1])
Physician review 1 Physician
Code List
10. 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
10. Physician review #1: Date sent to reviewer
date
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Physician review 1 Date received from reviewer
Item
10. Physician review #1: Date received from reviewer
date
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
11. Physician review #2: Physician
integer
C0184806 (UMLS CUI [1])
Physician review 1 Physician
Code List
11. 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
11. Physician review #2: Date sent to reviewer
date
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1515023 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Physician review 2 Date received from reviewer
Item
11. Physician review #2: Date received from reviewer
date
C0031831 (UMLS CUI [1,1])
C3166277 (UMLS CUI [1,2])
C1514756 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
CEC Coordinator comments
Item
12. CEC Coordinator comments
text
C0947611 (UMLS CUI [1])
CV event number
Item
13. CV event number
text
C2826275 (UMLS CUI [1])
Adverse event reference identifier
Item
14. Adverse event reference identifier
text
C1519255 (UMLS CUI [1,1])
C2348585 (UMLS CUI [1,2])
Adverse event term
Item
15. Adverse event term
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
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