Adjudication Events - Coronary Revascularization

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StudyEvent: ODM
1. Adjudication Events - Coronary Revascularization

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Administrative data

Item Group

Administrative data

Site

Item

Site

text

Subject

Item

Subject

text

Visit Name

Item

Visit Name

text

Visit Name

Code List

Visit Name

CL Item

Adjudication (1)

Status

Item

Status

text

Document Number

Item

Document Number

text

Coronary Revascularization

Item Group

Coronary Revascularization

Please document all coronary revascularizations

Item

Please document all coronary revascularizations

text

Please document all coronary revascularizations

Code List

Please document all coronary revascularizations

CL Item

Percutaneous coronary intervention (1)

CL Item

Coronary artery bypass graft procedure (2)

CL Item

Other coronary revascularization procedure (3)

Percutaneous coronary intervention

Item Group

Percutaneous coronary intervention

Date

Item

Date

date

Time

Item

Time

time

Were stents placed?

Item

Were stents placed?

boolean

If Yes, type of stent

Item

If Yes, type of stent

text

If Yes, type of stent

Code List

If Yes, type of stent

CL Item

Bare-metal (1)

CL Item

Drug-eluting (2)

Number of stents

Item

Number of stents

integer

Coronary artery bypass graft procedure

Item Group

Coronary artery bypass graft procedure

Date

Item

Date

date

Time

Item

Time

time

Number of bypassed vessels

Item

Number of bypassed vessels

integer

Specify other coronary revascularization procedure

Item Group

Specify other coronary revascularization procedure

Type

Item

Type

text

Date

Item

Date

date

Time

Item

Time

time

AE Details

Item Group

AE Details

AE / SAE Number

Item

AE / SAE Number

integer

Did the subject have this coronary revascularization procedure during a hospitalization for an acute myocardial infraction or angina or chest pain?

Item

Did the subject have this coronary revascularization procedure during a hospitalization for an acute myocardial infraction or angina or chest pain?

text

Did the subject have this coronary revascularization procedure during a hospitalization for an acute myocardial infraction or angina or chest pain?

Code List

Did the subject have this coronary revascularization procedure during a hospitalization for an acute myocardial infraction or angina or chest pain?

CL Item

Yes (please complete this form and provide the AE/SAE event number) (1)

CL Item

No (2)

Was this an elective/non-emergency procedure?

Item

Was this an elective/non-emergency procedure?

boolean

Did the subject have this procedure as a result of another Adverse Event or Serious Adverse Event?

Item

Did the subject have this procedure as a result of another Adverse Event or Serious Adverse Event?

boolean

If Yes, please record AE/SAE number

Item

If Yes, please record AE/SAE number

integer

Did myocardial infraction occur during or after the procedure?

Item

Did myocardial infraction occur during or after the procedure?

text

Did myocardial infraction occur during or after the procedure?

Code List

Did myocardial infraction occur during or after the procedure?

CL Item

Yes (please record event on Acute Myocardial Infraction/Hospitalized Angina or Chest Pain form) (1)

CL Item

No (please fill in all the cardiac enzyme/marker measurements available. For a specific enzyme/marker both the peak value and the upper limit of normal should be stated in the same unit) (2)

Enzyme Value Data

Item Group

Enzyme Value Data

Did a cerebrovascular accident (CVA) occur after the procedure?

Item

Did a cerebrovascular accident (CVA) occur after the procedure?

integer

Did a cerebrovascular accident (CVA) occur after the procedure?

Code List

Did a cerebrovascular accident (CVA) occur after the procedure?

CL Item

Yes (record event on the Stroke/TIA form) (1)

CL Item

No (2)

Did the subject die as a direct consequence of the procedure?

Item

Did the subject die as a direct consequence of the procedure?

text

Did the subject die as a direct consequence of the procedure?

Code List

Did the subject die as a direct consequence of the procedure?

CL Item

Yes, complete the Death form (1)

CL Item

No (2)

CK-MB

Item Group

CK-MB

Was the value examination done?

Item

Was the value examination done?

boolean

Pre-Procedure value

Item

Pre-Procedure value

text

Date sample taken

Item

Date sample taken

date

Time

Item

Time

time

Post-Procedure peak value

Item

Post-Procedure peak value

text

Date sample taken

Item

Date sample taken

date

Time

Item

Time

time

Upper Limit of Normal

Item

Upper Limit of Normal

text

Enzyme Unit

Item

Enzyme Unit

text

Troponin I

Item Group

Troponin I

Was the value examination done?

Item

Was the value examination done?

boolean

Pre-Procedure value

Item

Pre-Procedure value

text

Date sample taken

Item

Date sample taken

date

Time

Item

Time

time

Post-Procedure peak value

Item

Post-Procedure peak value

text

Date sample taken

Item

Date sample taken

date

Time

Item

Time

time

Upper Limit of Normal

Item

Upper Limit of Normal

text

Enzyme Unit

Item

Enzyme Unit

text

Troponin T

Item Group

Troponin T

Was the value examination done?

Item

Was the value examination done?

boolean

Pre-Procedure value

Item

Pre-Procedure value

text

Date sample taken

Item

Date sample taken

date

Time

Item

Time

time

Post-Procedure peak value

Item

Post-Procedure peak value

text

Date sample taken

Item

Date sample taken

date

Time

Item

Time

time

Upper Limit of Normal

Item

Upper Limit of Normal

text

Enzyme Unit

Item

Enzyme Unit

text

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