Item
2. Adjudication
text
Code List
2. 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
Code List
If cardiovascular death - CHD, select one
CL Item
Sudden death (76)
CL Item
Arrhythmia (ventricular fibrillation or other lethal arrhythmias without known secondary cause) (48)
CL Item
Congestive heart failure/shock (49)
CL Item
Death of unknown origin (33)
Item
If [76] sudden death, select one
integer
Code List
If [76] sudden death, select one
Cardiovascular death - CHD other specification
Item
If [OT] other, specify
text
Item
If [33] death of unknown origin, select one
integer
Code List
If [33] 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
text
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 causes of death, select one
text
Code List
If other vascular causes of death, select one
CL Item
Pulmonary embolism (1)
CL Item
Peripheral arterial disease (46)
Cardiovascular death - Non-CHD other speicification
Item
If [OT] other, specify
text
Item
If non-cardiovascular death, select one
text
Code List
If non-cardiovascular death, select one
CL Item
[58] Hemorrhage ([58] Hemorrhage)
CL Item
[59] Neoplasm/cancer ([59] Neoplasm/cancer)
CL Item
Infection/sepsis (60)
CL Item
Post non-cardiovascular surgery (53)
non-cardiovascular death other specification
Item
If [OT] other, specify
text
Item
3. Was this event related to a stent thrombosis?
text
Code List
3. Was this event related to a stent thrombosis?
Date of adjudication
Item
4. Date of adjudication
date
Trigger number
Item
5. Trigger number
text
Item
6. 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
7. Date of status change
date
Item
8. Physician review #1: Physician
integer
Code List
8. Physician review #1: Physician
Physician review 1 Date sent to reviewer
Item
8. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
8. Physician review #1: Date received from reviewer
date
Item
9. Physician review #2: Physician
integer
Code List
9. Physician review #2: Physician
Physician review 2 Date sent to reviewer
Item
9. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
9. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
10. CEC Coordinator comments
text
CV event number
Item
11. CV event number
text
Adverse event reference identifier
Item
12. Adverse event reference identifier
text
Adverse event term
Item
13. Adverse event term
text