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ID
26196
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 -revascularisation Repeating form (Scheduled visits)
Stichworte
Versionen (3)
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Rechteinhaber
GlaxoSmithKline
Hochgeladen am
11. Oktober 2017
DOI
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Creative Commons BY-NC 3.0
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CEC - revascularisation GSK study Chronic Coronary Heart Disease NCT00799903
CEC - revascularisation GSK study Chronic Coronary Heart Disease NCT00799903
Ähnliche Modelle
CEC - revascularisation GSK study Chronic Coronary Heart Disease NCT00799903
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of procedure
Item
1. Date of procedure
date
Start time of procedure
Item
1. Start time of procedure
time
CL Item
PCI - single vessel (CA)
CL Item
PCI - multiple vessels (CC)
CL Item
CABG (CE)
CL Item
Revascularisation procedure attempted but not successful (C09)
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
number of stents bare metal single vessel
Item
If PCI - single vessel with stent (bare metal), indicate number of stents
integer
PCI single vessel with stent Drug-eluting
Item
If PCI - single vessel with stent: C03 Drug-eluting
boolean
number of stents drug-eluting single vessel
Item
If PCI - single vessel with stent (drug-eluting), indicate number of stents
integer
CL Item
without stent (C04)
CL Item
with stent (CD)
PCI multiple vessels with stent Bare metal
Item
If PCI - multiple vessels with stent: C05 Bare metal
boolean
number of stents bare metal multiple vessels
Item
If PCI - multiple vessels with stent (bare metal), indicate number of stents
integer
PCI multiple vessels with stent Drug-eluting
Item
If PCI - multiple vessels with stent: C06 Drug-eluting
boolean
number of stents drug-eluting multiple vessels
Item
If PCI - multiple vessels with stent (drug-eluting), indicate number of stents
integer
CABG Arterial graft
Item
If CABG: C07 Arterial graft
boolean
CABG arterial graft number
Item
Number of grafts
integer
CABG Saphenous vein graft
Item
If CABG: C08 Saphenous vein graft
boolean
CABG Saphenous vein graft number
Item
Number of grafts
integer
Item
3. Was this a revascularisation of a target lesion from PCI that was performed prior to randomization?
text
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
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
Non-urgent coronary revascularisation
Item
Criteria for urgent coronary revscularisation for myocardial ischemia not met: [71] Non-urgent coronary revascularisation
boolean
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
Item
5. Was this event related to a stent thrombosis?
text
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
Trigger number
Item
7. Trigger number
text
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
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
Physician review 1 Date received from reviewer
Item
10. Physician review #1: Date received from reviewer
date
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
Physician review 2 Date received from reviewer
Item
11. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
12. CEC Coordinator comments
text
CV event number
Item
13. CV event number
text
Adverse event reference identifier
Item
14. Adverse event reference identifier
text
Adverse event term
Item
15. Adverse event term
text