Date of event
Item
1. Date of event
date
Time of event
Item
1. Time of event
time
Treatments Intravenous diuretic
Item
2. Treatments: [E01] Intravenous diuretic
boolean
Treatments Escalation of diuretic dose
Item
2. Treatments: [E02] Escalation of diuretic dose
boolean
Treatments Administration of inotropes
Item
2. Treatments: [E03] Administration of inotropes
boolean
Treatments Intra-aortic balloon pump
Item
2. Treatments: [E04] Intra-aortic balloon pump
boolean
Hidden Method of diagnosis Chest x-ray
Item
3. Method of diagnosis: [E05] Chest x-ray
boolean
Hidden method of diagnosis Pulmonary edema
Item
3. Method of diagnosis: [E06] Pulmonary edema, rales > 1/3 up the lung fields thought to be of cardiac causes
boolean
Hidden Method of diagnosis PCWP
Item
3. Method of diagnosis: [E07] PCWP > 18 mmHg
boolean
Hidden Method of diagnosis BNP
Item
3. Method of diagnosis: [E08] BNP
boolean
Hidden BNP value
Item
BNP, enter value
float
Hidden BNP result not available
Item
BNP result not available
boolean
Hidden Method of diagnosis NT pro-BNP
Item
3. Method of diagnosis: [E09] NT pro-BNP
boolean
Hidden NT pro-BNP value
Item
NT pro-BNP, enter value
float
Hidden NT pro-BNP result not available
Item
NT pro-BNP result not available
boolean
Method of diagnosis Chest imaging
Item
4. Method of diagnosis: [E14] Chest imaging
boolean
Method of diagnosis Pulmonary edema
Item
4. Method of diagnosis: [E06] Pulmonary edema (i.e., rales > 1/3 up the lung fields thought to be of cardiac causes)
boolean
Method of diagnosis Pulmonary capillary wedge pressure
Item
4. Method of diagnosis: [E07] Pulmonary capillary wedge pressure > 18 mmHg
boolean
Method of diagnosis BNP
Item
4. Method of diagnosis: [E15] BNP
boolean
BNP value
Item
BNP, enter value
float
BNP result not available
Item
BNP result not available
boolean
Method of diagnosis NT pro-BNP
Item
4. Method of diagnosis: [E16] NT pro-BNP
boolean
NT pro-BNP value
Item
NT pro-BNP, enter value
float
NT pro-BNP result not available
Item
NT pro-BNP result not available
boolean
Item
5. NYHA functional class code
text
Code List
5. NYHA functional class code
narrative
Item
6. Provide narrative
text
Date documents sent to CEC Document Group
Item
7. Date documents sent to CEC Document Group
date
Item
8. Adjudication
text
Code List
8. Adjudication
CL Item
Does not meet criteria for heart failure (NC)
CL Item
Hospitalisation for heart failure (72)
criteria for heart failure not met specification
Item
8. If criteria for heart failure not met, specify
text
Date of adjudication
Item
9. Date of adjudication
date
Trigger number
Item
10. Trigger number
text
Item
11. 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
12. Date of status change
date
Item
13. Physician review #1: Physician
integer
Code List
13. Physician review #1: Physician
Physician review 1 Date sent to reviewer
Item
13. Physician review #1: Date sent to reviewer
date
Physician review 1 Date received from reviewer
Item
13. Physician review #1: Date received from reviewer
date
Item
14. Physician review #2: Physician
integer
Code List
14. Physician review #2: Physician
Physician review 2 Date sent to reviewer
Item
14. Physician review #2: Date sent to reviewer
date
Physician review 2 Date received from reviewer
Item
14. Physician review #2: Date received from reviewer
date
CEC Coordinator comments
Item
15. CEC Coordinator comments
text
CV event number
Item
16. CV event number
text
Adverse event reference identifier
Item
17. Adverse event reference identifier
text
Adverse event term
Item
18. Adverse event term
text