Date of procedure
Item
1. Date of procedure
date
Start time of procedure
Item
1. Start time of procedure
time
Item
2. Revascularisation procedure
text
Code List
2. Revascularisation procedure
CL Item
PCI - single vessel (CA)
CL Item
PCI - multiple vessels (CC)
CL Item
Revascularisation procedure attempted but not successful (C09)
Item
If PCI - single vessel, select one
text
Code List
If PCI - single vessel, select one
CL Item
without stent (C01)
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
Item
If PCI - multiple vessels, select one
text
Code List
If PCI - multiple vessels, select one
CL Item
without stent (C04)
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?
Item
6. Adjudication
text
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
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?
Date of adjudication
Item
6. Date of adjudication
date
Trigger number
Item
7. Trigger number
text
Item
8. CEC Status
integer
CL Item
Coordinator Screen check (2)
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
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
Item
10. Physician review #1: Physician
integer
Code List
10. Physician review #1: Physician
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
Item
11. Physician review #2: Physician
integer
Code List
11. Physician review #2: Physician
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