Download Form 404 – Report of Cardiovascular Events

SELECT Study Manual
Section 9: Forms Completion and Data Submission
Form 404 – Report of Cardiovascular Events
Version 2.1 – August 14, 2008
Form 404, Page 1 of 5
SELECT Study Manual
Section 9: Forms Completion and Data Submission
Form 404 – Report of Cardiovascular Events
Submission:
Completed by:
When to complete
and submit:
Web
Study Site Staff
When the participant reports a Grade 3 or 4 cardiovascular event.
When the participant reports a cardiovascular surgery or procedure.
Use the standard contact number for the current or closest regularly
Contact Number:
scheduled future contact.
(For example, if a participant reports a Grade 3 or 4 cardiovascular
event at Contact 020, use Contact 020 on Form 404 – Report of
Cardiovascular Events when submitting information on this event.)
*Supplemental documentation required for items in Parts 1 and 2 on this form.
Form Instructions:
Use this form only to record Grade 3 and 4 cardiovascular events and to report cardiovascular
surgeries and procedures. For grades 3 and 4 cardiovascular events, submission of Form 409 –
SELECT Serious Adverse Event Report to the Southwest Oncology Group Operations Office is also
required per Section 16.0 of the SELECT Protocol (S0000) and Section 9.9 – Form Instructions for
Form 409 – SELECT Serious Adverse Event Report.
Part 1: Stroke
Did the participant have a stroke? If Yes, indicate how the diagnosis was made:
This question asks Study Site staff to indicate if the participant had a stroke and to clarify how the
type of stroke was diagnosed. This will help determine whether the stroke was ischemic or
hemorrhagic. Try to obtain copies of the CT scans or any other tests used to diagnose the event.
See Section 8 – Endpoints for more information about documentation.
Complete this question and press the “Submit/Continue” button to move on to the rest of this
form.
Part 2: Specify each cardiovascular event, the grade of the event, and the date of the event.
If the participant is On Supplements at the time of his serious cardiovascular event, SELECT does not
require the participant be taken Off Supplements. However, if the participant's physician
recommends that the participant discontinue use of the Study Supplements or the participant does not
wish to continue taking Study Supplements, take the participant Off Supplements and complete and
submit Form 401 – Off Supplements Notice in addition to this form.
Enter the cardiovascular event using the drop-down list provided. Based on further information
about the event, classify it as Grade 3 or Grade 4. Use the Notes field to clarify “NOS” and
“Other” events. See “Table 1: Cardiovascular Event Drop-list” at the end of these instructions for
a complete list of the drop-list choices and codes.
Do not report Grade 3 hypertension on this form.
If a participant had events in two different categories, record both events and their grades. If the
participant has had two events in the same event category in the period being reported on, report
only the most serious event in its category.
Version 2.1 – August 14, 2008
Form 404, Page 2 of 5
SELECT Study Manual
Section 9: Forms Completion and Data Submission
If the participant reports having a stroke (CNS hemorrhage Grade 4, Cerebrovascular ischemia
Grade 4, Stroke, NOS Grade 4), be sure Part 1 is completed accordingly.
Events should be graded according to the NCI Common Toxicity Criteria (CTC) Version 2.0.
Some events listed on this form are not part of the CTC Version 2.0. Grade these events using the
following scale: 3=severe, 4=life-threatening. Note that a grade 5 event must be reported on Form
405 – Report of Death and not on Form 404.
If the participant reports having an event not currently listed on this form, indicate the code as
Cardiovascular-other. In the Notes field, specify the toxicity as it is listed in the Common
Toxicity Criteria (CTC) Version 2.0. All Cardiovascular-other codes will be queried.
For example: A participant reports Angina, Acute myocardial infarction, and Hemorrhagic stroke
(diagnosed with MRI) since his last contact (020). He is now at his Contact 026 visit. Use
Contact 026 on the form.
Because the participant had an hemorrhagic stroke diagnosed with an MRI, complete Part 1
by marking “Yes” and then mark “CT or MRI finding of blood or hemorrhage.”
In Part 2, Angina corresponds to Cardiac ischemia/infarction Grade 3. Acute myocardial
infarction corresponds to Cardiac ischemia/infarction Grade 4. Hemorrhagic stroke
corresponds to CNS hemorrhage Grade 4.
Record Cardiac ischemia/infarction, Grade 4, and the date of the Acute myocardial
infarction.
Record CNS hemorrhage, Grade 4, and the date of the Hemorrhagic stroke.
Part 3: Specify each cardiovascular surgery or procedure.
Enter the cardiovascular surgery or procedure using the drop-down list provided and the date.
Press the “Add” button to submit. See “Table 2: Cardiovascular Surgery and Procedure Droplist” at the end of these instructions for a complete list of the drop-list choices.
If the participant had more than one cardiovascular surgery or procedure, repeat the selection and
submission process until all cardiovascular surgeries and procedures have been entered.
If the participant reports having a cardiovascular surgery or procedure, but cannot recall what it
was, indicate the procedure as Unknown. In the Notes field, provide any details you can about
the cardiac surgery or procedure. All entries of Unknown will be queried.
Do not report cardioversion or aneurysm repair.
The cardiovascular surgeries and procedures SELECT is collecting are interventions. If the
participant reports a cardiovascular surgery or procedure that is diagnostic in nature, do not mark
this box. Examples of diagnostic procedures that should not be reported are listed below.
• Angiography
• Diagnostic heart catheterizations (where no angioplasty or stenting is done)
• Echocardiograms
• Exercise stress tests
• Perfusion scans
Version 2.1 – August 14, 2008
Form 404, Page 3 of 5
SELECT Study Manual
Section 9: Forms Completion and Data Submission
Table 1: Cardiovascular Events Drop-list
Cardiovascular event drop-list text
Arrhythmia, NOS
Conduction abnormality/block
Nodal/junctional dysrhythmia
Palpitations
Prolonged QTc interval
Sinus tachycardia
Sinus bradycardia
Supraventricular arrhythmia
Ventricular arrhythmia
LVEF decrease/CHF
Myocarditis
Cardiac ischemia/infarction
Troponin T (cTnT) increase
Abnormal troponin I (cTnI)
Peripheral arterial ischemia
Visceral arterial ischemia
Cerebrovascular ischemia
Pericar. effusion/pericarditis
Hypertension
Hypotension
Thrombosis/embolism
Edema
Phlebitis
Syncope
Vasovagal episode
Acute vascular leak syndrome
Cardiovascular-other
RT-late cardiac morbidity
Surgery-injury of vein/artery
Cardiomyopathy
Aneurysm
Aortic Stenosis
Carotid Stenosis
Valve Disease
Stroke, NOS
CNS hemorrhage
Version 2.1 – August 14, 2008
Stroke?
Yes (Grade 4)
Yes (Grade 4)
Yes (Grade 4)
Form 404, Page 4 of 5
SELECT Study Manual
Section 9: Forms Completion and Data Submission
Table 2: Cardiovascular Surgery and Procedure Drop-list
Items in bold are in the drop-list; italicized items are for reference.
Ablation therapy
Angioplasty
Below is a list of different kinds of angioplasty:
Angioplasty
Atherectomy
Balloon angioplasty
Balloon dilation of artery
Laser angioplasty
Plaque removal with a laser
Removal of artery plaque
Stent placement
Bypass surgery
Below are other names for bypass surgery:
CABG
Coronary artery bypass grafting surgery
Coronary artery bypass surgery
Non-coronary bypass (e.g., femoral-popliteal bypass)
Carotid endarterectomy
Correction of congenital heart defects
Heart transplant
Heart valve repair
Below is a list of different types of heart valve repair:
Heart valve dilation
Valvuloplasty
Annuloplasty
Heart valve replacement
Internal cardioverter defibrillator placement (or replacement)
Pacemaker placement (or replacement)
Unknown
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