Saharaproject.ca

MICHELANGELO: OASIS 5
(UA/NSTEMI)
An international randomized double-blind study evaluating the efficacy and safety of fondaparinux versus enoxaparin in the acute treatment of unstable angina / non ST-segment elevation MI 191
Croatia
Canadian Cardiovascular Collaboration (CCC) Project Office Population Health Research InstituteHGH - McMaster Clinic, 237 Barton Street EastHamilton, Ontario Sanofi-Synthelabo Recherche1, avenue Pierre Brossolette91385 Chilly Mazarin CedexFrance FAX CASE REPORT FORMS TO DATAFAX: 0 800 22 0112 WSC 6004 Study Nnmber: 135
Do NOT fax this page.
MICHELANGELO:
ELIGIBILITY FORM
DataFax #135
Plate #100
Visit #001
Croatia
191
Note: Patient ID will be provided by randomization service
A. INCLUSION CRITERIA
( Must be ‘Yes’ to 1 and 2 and 3):
1. Ischemic chest pain/ischemic symptoms occurring at rest or with minimal activity (> 5 minutes or requiring sublingual nitroglycerin for relief of pain) 2. Able to randomize within 24 hours of the onset of the most recent episode of symptoms 3. At least two of the following three criteria are met (please specify): c) ECG changes compatible with ischemia (i.e., at least one of the following:) ST depression > 1 mm in 2 contiguous leads B. EXCLUSION CRITERIA (must be ‘No’ to all):
2. Any contraindication to low molecular weight heparin 3. Hemorrhagic stroke within the last 12 months 4. Indication for anticoagulation other than ACS 5. Pregnancy or women of childbearing potential who are not using an 6. Co-morbid condition with life expectancy less than 6 months 7. Prior enrollment in one of the fondaparinux ACS trials or currently receiving an experimental pharmacologic agent 8. Revascularization procedure already performed for the qualifying event 9. Severe renal insufficiency (i.e. serum creatinine > 3 mg/dL or 265 µmol/L) If all eligibility criteria are met, proceed to CRF 2.
This form must be faxed to the CCC Project Office within 24 - 48 hours of randomization.
MICHELANGELO:
OASIS 5
RANDOMIZATION FORM
DataFax #135
Plate #002
Visit #001
Croatia
191
A. ELIGIBILITY ASSESSMENT:
Before calling the Randomization Service, complete the following with an X:
Applies only to those countries participating
in one of these substudies
All eligibility criteria met (CRF 1) Blood drawn for admission laboratory tests 2. Patient’s weight in kilograms (required for weight-adjusted enoxaparin or enoxaparin-placebo): 3. Clinical diagnosis at the time of randomization (mark one only): B. TREATMENT ALLOCATION:
PLEASE CALL THE RANDOMIZATION SERVICE: 0 800 22 0112 WSC 6003 Study Number: 135
THE 24-HOUR RANDOMIZATION SERVICE WILL PROVIDE THE FOLLOWING INFORMATION:
2. Patient ID Number: Record this number at the top of both CRFs 1 and 2 and all subsequent CRFs for this patient.
3. Treatment Number for both study drug preparations
Affix Label from
Record here as assigned by randomization service:
Patient’s Treatment
a)Give initial dose of enoxaparin/enoxaparin-placebo 1 mg/kg subcutaneously
b) Give initial dose of study drug fondaparinux/fondaparinux-placebo 2.5 mg sc
Note: Follow the study regimen described on Pocket Card and in the Investigator’s Manual
4. Has this patient been randomized to one of the catheterization substudies?
This form must be faxed to the CCC Project Office within 24-48 hours of randomization.
MICHELANGELO:
OASIS 5
BASELINE FORM PAGE 1 OF 2
DataFax #135
Plate #003
Visit #002
Croatia
191
CLINICAL ASSESSMENT:
Blood Label #
Affix Specimen Collection
Barcoded Label here
analysis:(Selected countries only)
6. Check if additional bloods will be drawn for biomarker substudy at 6 hrs, 24 hrs and 72 hrs.
If Checked, complete
7. BASELINE ECG:
a) ECG (give most significant code from facing page for both type & location)
If ‘9’, specify:
If ‘9’, specify:
b) ECG Rhythm:(give most significant If ‘9’, specify:
ADMISSION LABORATORY TESTS:
Provide results for the initial value for all tests done if available; mark others ‘ND’ (not done)
Upper Limit of Normal
Fax this form to the CCC Project Office within 3 days of randomization
MICHELANGELO:
OASIS 5
BASELINE FORM PAGE 2 OF 2
DataFax #135
Plate #004
Visit #002
Croatia
191
HISTORY:
Other objective evidence (specify): 12. Smoker: (mark [x] one box only)
13. Other Recreational Drug used within last 12 months: (mark [x] all that apply)
Provide date
and time only if
drug was last
used within
previous
PATIENT INFORMATION:
mark [x] units
If ’11’, specify:
4. Employment status: (mark [x] one box only)
over the course of the subject’s working life If ‘10’, specify:
Fax the Baseline Form to the CCC Project Office within 3 days of randomization
MICHELANGELO:
OASIS 5
HOSPITAL DISCHARGE VISIT - PAGE 1 OF 3
DataFax #135
Plate #005
Visit #003
Croatia
191
HOSPITAL DISCHARGE:(Transfer to acute care facility should be included in the initial hospitalization)
(mark [X] only one box)
Transferred to long-term care/rehabilitation CATHETERIZATION SUBSTUDY: If this patient is enrolled in either catheterization substudy complete CRF 7C
CLINICAL EVENTS SINCE RANDOMIZATION :
If Yes, complete report:
Complete Death Report
Complete Associated MI
Report CRF 7A
Report No.(s)
Complete MI Report
, #
Refractory/Severe Ischemia
Report CRF 7B
Complete Stroke Report
, #
Complete Bleeding
, #
Report CRF 75
Complete SAE Report CRF 70 #
, #
Complete SAE CRF 70
, #
10. Has patient experienced any other relevant untoward medical event? Report below
Date of onset
Permanent discontinuation of study drug
(if Yes, report on CRF 7 question 4 and 5)
Fax this form to the CCC Project Office within 3 days of hospital discharge
MICHELANGELO:
OASIS 5
HOSPITAL DISCHARGE VISIT PAGE 2 OF 3
DataFax #135
Plate #006
Visit #003
Croatia
191
Within 7 Days Prior
During Initial
Randomization
Hospitalization
Discharge
CONCOMITANT MEDICATIONS:
Fax this form to the CCC Project Office within 3 days of hospital discharge
- HOSPITAL DISCHARGE VISIT- Page 2 of 3 - MICHELANGELO:
OASIS 5
HOSPITAL DISCHARGE VISIT 3 OF 3
DataFax #135
Plate #007
Visit #003
Croatia
191
INTERVENTIONS SINCE RANDOMIZATION:
if YES,
completeCRF 7E
Complete CRF 15
Complete CRF 16A &B #
Complete CRF 17
STUDY DRUG ADMINISTRATION
Mark [X] all doses of both study drugs administered after randomization.
1. Enoxaparin/Enoxaparin-Placebo
2. Fondaparinux/Placebo
twice daily sc injections
once daily sc injection
1st Dose 2nd Dose
1st Dose 2nd Dose
3. Was study drug given according to allocation at randomization?
If No, record incorrect Treatment Number given
4. Early permanent discontinuation of Enoxaparin/Placebo
Reason
If ‘9’ specify:
5. Early permanent discontinuation of Fondaparinux/Placebo
Yes Reason
If ‘9’ specify:
6. How will most of the patient’s hospitalization costs be covered? (mark [x] all that apply)
(Ensure that original
7. Date of next scheduled visit:
target visit schedule is
(30 days from randomization date)
maintained at next visit)
Fax this form to the CCC Project Office within 3 days of hospital discharge
MICHELANGELO:
ASSOCIATED MI REPORT
DataFax #135
Plate #031
Visit #003
Croatia
191
Use this page to report only Myocardial Infarction associated with presenting symptoms at study entry.
Associated MI is defined as: an MI associated with presenting symptoms initially diagnosed on admission as
ACS (unstable angina or MI without ST segment elevation) with subsequent rise in cardiac enzymes or
persistent ECG changes such that the diagnosis becomes an MI.
1. CHEST PAIN: Was there characteristic ischemic chest pain lasting longer than 20
minutes or other ischemic symptoms leading to randomization? 2. ECG: a) Was there subsequent ECG evidence of myocardial
infarction associated with presenting symptoms? If YES, record details of ECG with most significant changes below:
d) Type of ECG change:(Record most significant code from facing page) (If ‘9’, specify):
e) Main ECG location: (Record most significant code from facing page) (If ‘9’, specify):
3. CARDIAC ENZYMES
(Include initial and peak values of 2 cardiac
enzymes or markers related to this episode)
(check only one)
a) Cardiac enzyme or
Upper Limit of Normal
(check only one)
b) Other Cardiac enzyme or marker:
Upper Limit of Normal
Fax this form to the Project Office within 48 hours of diagnosis.
MICHELANGELO:
OASIS 5
REFRACTORY/SEVERE ISCHEMIA DURING INITIAL HOSPITALIZATION CRF 7B
DataFax #135
Plate #032
Visit #003
Croatia
191
REPORT ALL EPISODES OF REFRACTORY AND/OR SEVERE ISCHEMIA (i.e. must have ECG evidence of ischemia)
DURING INITIAL HOSPITALIZATION
Refractory Ischemia = recurrent chest pain (> 5 min) + on optimal therapy + new ischemic ECG changes +
or transfer for procedure within 48 hrs of symptom onset
intervention
Severe Ischemia = episode of chest pain (> 5 min) + on optimal therapy + new ischemic ECG changes
SOURCE DOCUMENTATION REQUIRED FOR REFRACTORY ISCHEMIA: Baseline and subsequent ECGs
with evidence of new ischemia, OR/Procedural Report, progress notes, consultant’s report or discharge summary.
Fax this form to the CCC Project Office within 48 hours of hospital discharge.
- REFRACTORY/SEVERE ISCHEMIA (INITIAL HOSPITALIZATION) - MICHELANGELO:
OASIS 5
CATHETERIZATION SUBSTUDY REPORT
Revised CRF 7C
DataFax #135
Plate #107
Visit #003
Croatia
191
Complete this CRF ONLY for those patients randomized to one of the Catherization Substudies
(Timing of Intervention or Women’s performed in select countries ONLY)
All in-hospital procedures must be reported on CRF 7 with details of the procedure recorded on the appropriate
study intervention CRFs 15, 16 and/or 17 whether or not they are associated with the catheterization substudy.
1. This patient has been randomized to:
Timing of Intervention Catheterization Substudy Complete Section A
Complete Section B
A. TIMING OF INTERVENTION CATHETERIZATION SUBSTUDY
b) Was coronary angiography performed according to the randomization? i) In patients randomized to early angiography, indicate whether angiography was Delayed
or Not Done
and state most significant reason: (see facing page for codes) If ‘17’,specify:
If ‘17’,specify:
ii) In patients randomized to delayed angiography, indicate whether angiography was performed Early
or Not Done
and state most significant reason: (see facing page for codes) If ‘17’,specify:
If ‘17’,specify:
B. WOMEN’S CATHETERIZATION SUBSTUDY
Date and time of angiography if performed: b) Was coronary angiography performed according to the randomization? i) If patient randomized to invasive arm, state most significant reason why angiography not performed:
Reason: (see facing page for codes)
If ‘17’,specify:
non-invasive arm, state most significant reason why angiography performed:
Reason: (see reverse for codes)
If ‘17’,specify:
c) Has patient completed Quality of Life Questionnnaires? (mark [x] all that apply )
SAQ ( CRFs 300 - 302)
EQ5D ( CRFs 200 - 202)
SF-36v ( CRFs 400 - 404)
Fax this form to the CCC Project Office within 48 hours of hospital discharge.
MICHELANGELO:
OASIS 5
BIOMARKER SUBSTUDY
DataFax #135
Plate #108
Visit #003
Croatia
191
ADDITIONAL BLOOD SAMPLES FOR BIOMARKER SUBSTUDY
1. Was blood drawn for central analysis at 6 hours post-randomization?
Blood Label #
Affix Specimen Collection
Barcoded Label here
2. Was blood drawn for central analysis at 24 hours post-randomization?
Blood Label #
Affix Specimen Collection
Barcoded Label here
3. Was blood drawn for central analysis at 72 hours post-randomization?
Blood Label #
Affix Specimen Collection
Barcoded Label here
Fax this form to the CCC Project Office within 3 days of completion
MICHELANGELO:
INTERVENTION TRANSFER REPORT
DataFax #135
Plate #109
Visit #003
Croatia
191
This form is only to be completed for patients transferred to another centre for Angiography, PCI or CABG.
A. INTERVENTIONS PERFORMED AT CATHETERIZATION CENTRE
B. CATHETERIZATION CENTRE INFORMATION
If Centre No. not
available please
complete the following:
Date of Transfer
Date of Discharge/Transfer
from Randomizing Centre
from your centre
Transferred to long-term care/rehabilitation Was study drug administered as per protocol? Was study drug re-started after procedure(s)? C. EVENTS AT CATHETERIZATION CENTRE
If an event* occurs while at the Catheterization Centre, please inform the Randomizing Centre immediately,and please provide supporting documentation to the Randomizing Centre as soon as possible.
*Serious Adverse Events (SAE) (definition on reverse page) must be reported to the coordinating office (CCCPO)within 24 hours of occurence. Therefore, notify the Randomizing Centre immediately, and forward the supportingdocumentation to the Randomizing Centre within 24 hours of the event onset. This form must be returned to the Randomizing Centre within 24 - 48 hours of transfer.
MICHELANGELO:
OASIS 5
30 DAY FOLLOW-UP - Page 1 of 2
DataFax #135
Plate #008
Visit #004
Croatia
191
30 DAY FOLLOW-UP VISIT:
1. How were these follow-up data obtained? (Office follow-up is recommended for all patients)
Readmitted to hospital after initial event CLINICAL EVENTS AFTER HOSPITAL DISCHARGE:
If Yes, complete report:
Complete Death Report CRF 99
Report No.(s)
Complete MI Report CRF 30
, #
Complete Rehospitalization
for Unstable Angina
, #
Report CRF 50
Complete Stroke
, #
Report CRF 40
Complete Other Hospitalization
Report CRF 55
, #
Complete Bleeding
, #
Report CRF 75
Complete SAE Report CRF 70
, #
Complete SAE Report CRF 70
, #
12. Has patient experienced any other relevant untoward medical event? Report below
Date of onset
Fax this form to the CCC Project Office within 3 days of follow-up
MICHELANGELO:
OASIS 5
30 DAY FOLLOW-UP - Page 2 of 2
DataFax #135
Plate #009
Visit #004
Croatia
191
After Hospital
After Hospital
CONCOMITANT MEDICATIONS:
Discharge
Discharge
INTERVENTIONS AFTER HOSPITAL DISCHARGE:
Report No.(s)
If Yes, complete report:
Complete CRF 15
, #
Complete CRF 16 A &B #
, #
Complete CRF 17
, #
LIFESTYLE MODIFICATION:
If No, go to
b) Has the patient used any aids for smoking cessation in the last 30 days? c) Has patient been advised about smoking cessation at this visit? 2. a) Is the patient currently enrolled in a cardiac rehabilitation program? b) Is the patient exercising regularly (>30 min 3 times/ week)? c) Has patient received counselling for dietary modification? FOLLOW-UP:
(Ensure that original
target visit schedule is
maintained at next visit)
Fax this form to the CCC Project Office within 3 days of follow-up
MICHELANGELO:
OASIS 5
90 DAY FOLLOW-UP - Page 1of 2
DataFax #135
Plate #010
Visit #005
Croatia
191
90 DAY FOLLOW-UP VISIT:
1. How were these follow-up data obtained? (Office follow-up is recommended for all patients)
Readmitted to hospital after initial event CLINICAL EVENTS SINCE LAST VISIT:
If Yes, complete report:
Complete Death Report CRF 99
Report No.(s)
Complete MI Report CRF 30
, #
Complete Rehospitalization
for Unstable Angina
, #
Report CRF 50
Complete Stroke
, #
Report CRF 40
Complete Other Hospitalization
, #
Report CRF 55
Complete Bleeding
, #
Report CRF 75
Complete SAE Report CRF 70
, #
Complete SAE Report CRF 70
, #
12. Has patient experienced any other relevant untoward medical event? Report below
Date of onset
Fax this form to the CCC Project Office within 3 days of follow-up
MICHELANGELO:
90 DAY FOLLOW-UP - Page 2 of 2
DataFax #135
Plate #011
Visit #005
Croatia
191
CONCOMITANT MEDICATIONS:
Last Visit
Last Visit
INTERVENTIONS SINCE LAST VISIT: No
Report No.(s)
If Yes, complete report:
Complete CRF 15
, #
Complete CRF 16 A&B #
, #
Complete CRF 17
, #
LIFESTYLE MODIFICATION:
If No, go to
Has the patient used any aids for smoking cessation in the last 30 days? c) Has patient been advised about smoking cessation at this visit? a) Is the patient currently enrolled in a cardiac rehabilitation program? b) Is the patient exercising regularly (>30 min 3 times/ week)? c) Has patient received counselling for dietary modification? FOLLOW-UP:
(Ensure that original target visit schedule is
maintained at next visit)
Fax this form to the CCC Project Office within 3 days of follow-up
MICHELANGELO:
OASIS 5
180 DAYS or FINAL FOLLOW-UP - Page 1 of 2
DataFax #135
Plate #012
Visit #006
Croatia
191
180 DAY or FINAL FOLLOW-UP VISIT:
1. How were these follow-up data obtained? (Office follow-up is recommended for all patients)
Readmitted to hospital after initial event CLINICAL EVENTS SINCE LAST VISIT:
If Yes, complete report:
Complete Death Report CRF 99
Report No.(s)
Complete MI Report CRF 30
, #
Complete Rehospitalization
for Unstable Angina
, #
Report CRF 50
Complete Stroke
, #
Report CRF 40
Complete Other Hospitalization
Report CRF 55
, #
Complete Bleeding
Report CRF 75
, #
Complete SAE Report CRF 70
(if considered major bleeding)
, #
Complete SAE Report CRF 70
, #
12. Has patient experienced any other relevant untoward medical event? Report below
Date of onset
Fax this form to the CCC Project Office within 3 days of follow-up
MICHELANGELO:
180 DAYS or FINAL FOLLOW-UP - Page 2 of 2
DataFax #135
Plate #013
Visit #006
Croatia
191
CONCOMITANT MEDICATIONS:
Last Visit
Last Visit
INTERVENTIONS SINCE LAST VISIT:
If Yes, complete report:
Report No.(s)
Complete CRF 15
, #
Complete CRF 16 A&B#
, #
Complete CRF 17
, #
LIFESTYLE MODIFICATION:
If No, go to
b) Has the patient used any aids for smoking cessation in the last 30 days? c) Has patient been advised about smoking cessation at this visit? a) Is the patient currently enrolled in a cardiac rehabilitation program? b) Is the patient exercising regularly (>30 min 3 times/ week)? c) Has patient received counselling for dietary modification? FINAL FOLLOW-UP:
CRF 14 (Study Completion/Investigator’s Statement) completed:
Fax this form to the CCC Project Office within 3 days of follow-up
MICHELANGELO: STUDY COMPLETION / INVESTIGATOR’S FINAL STATEMENT
DataFax #135
Plate #014
Visit #006
Croatia
191
1. Has the patient completed the final follow-up visit? Refer to Contact Form CRF 20
2. Was the study drug unblinded at any time during the study? Please ensure that all supporting documents for all events for this patient have been sent to the
CCC Project Office.
I have reviewed the case report forms for this patient. To the best of my knowledge, the information
collected is complete and accurate.
Fax this form to the CCC Project Office within 48 hours of completion
- STUDY COMPLETION INVESTIGATOR’S FINAL STATEMENT- MICHELANGELO:
CORONARY ANGIOGRAPHY REPORT
DataFax #135
Plate #015
Croatia
191
Complete one report for each coronary angiography procedure performed on this patient
2. Indication for coronary angiography: (mark [X] one box only)
b) Check culprit lesion(s) if applicable Record percent stenosis in ALL vessels
Complete section c) ONLY for those patients with previous CABG surgery
c) Check culprit lesion(s) if applicable Record percent stenosis in ALL grafts
Quantitative Assessment
Qualitative Assessment
(mark [X] one box only)
Mild impairmentModerate impairmentSevere impairment 4. Did the results of the coronary angiography lead to a revascularization procedure? Provide most significant reason below: (mark [X] one box only)
Fax this form to the CCC Project Office within 48 hours of procedure
MICHELANGELO:
PCI REPORT - Page 1 of 2
DataFax #135
Plate #116
Croatia
191
2. Indication for percutaneous coronary intervention: ( mark [X] one box only) 3. Was PCI performed during initial hospitalization and within 8 days of randomization? a) Date of last fondaparinux/placebo injection prior to PCI: b) Date of last enoxaparin/placebo injection prior to PCI: c) Was catheter flushed with heparinized saline before insertion into patient? d) Indicate Contrast Media used during PCI e) First dose of fondaparinux/placebo given during PCI: g) Was additional dose of study drug (anticoagulant) from PCI kit given during PCI?
4. Were open-label (non-study) anticoagulants/antithrombins administered?
non-study
Dose of UFH:
Reason for UFH:
Bivalirudin
5. Was a GPIIb/IIIa receptor antagonist given during PCI? Upfront Specify
If YES Date started
6. Was a thienopyridine given prior to PCI? Specify
Fax this form to the CCC Project Office within 48 hours of procedure
MICHELANGELO:
OASIS 5
PCI REPORT - Page 2 of 2
DataFax #135
Plate #117
Croatia
191
1. PCI Procedure Chart to be completed for each PCI performed at this sitting: Angiographic
Max Stenosis
Thrombus
Location
see reverse
1=Yes,Bare Stent
see reverse 2=Yes,
for codes
for codes
Procedure
7. Were there any vascular site complications of PCI? Complete Bleeding Report CRF 75
8. Were there any other complications during PCI? If Yes, complete a) to d)
mark [x] all that apply
Open-label (non-study) anticoagulants/antithrombins given as a result of PCI complication(s): (mark [x] all that apply)
dose
dose
non-study
dose
Bivalirudin
Other(specify):
(mark [x] all that apply)
(Complete CRF 99)
(Complete CRF 30)
(Complete CRF 40)
9. Was study drug fondaparinux/placebo restarted (If Yes, provide date and time drug restarted)
10. Was study drug enoxaparin/placebo restarted (If Yes, provide date and time drug restarted)
Fax this form to the CCC Project Office within 48 hours of procedure
MICHELANGELO:
CABG SURGERY REPORT
DataFax #135
Plate #018
Croatia
191
Complete one report for each procedure performed on this patient
Mark [X] all
Mark [X] all
Mark [X] all
Mark [X] all that apply
grafts Other Arterial
Complete Bleeding Report CRF 75
7. a) Transfusions during 1st 24 hours post-op: b) Total Chest tube bleeding within 1st 24 hours post-op: 8. Was patient taking study drug within 24 hours prior to CABG surgery? Mark [x] all that apply
9. Was patient taking any antithrombotic medications 10. Was study drug restarted after CABG surgery? Fax this form to the CCC Project Office within 48 hours of CABG Surgery
MICHELANGELO:
DataFax #135
Plate #020
Croatia
191
USE THIS PAGE ONLY FOR THOSE PATIENTS WHO DID NOT COMPLETE FINAL FOLLOW-UP VISIT
Continue to try to make
contact as per instructions.
Other qualified professional (specify): 5. Who was contacted? (check all that apply) patient’s relative (relationship): 6. Did patient experience any one of the following since last visit? If the response to any of the questions above is YES or NO, please complete final follow-up visit CRFs
documenting the patient status as of the scheduled final visit date.
Fax this form to the CCC Project Office within 48 hours of completion
MICHELANGELO:
MI REPORT
DataFax #135
Plate #030
Croatia
191
1. Date of onset of Myocardial Infarction: 4. Elevation of Cardiac Enzymes or markers
consistent with myocardial infarction
(Include initial and peak values of 2 cardiac Total CK CK-MB
enzymes or markers related to this episode)
a) Cardiac enzyme or
marker: (check only one)
Upper Limit of Normal
(check only one)
b) Other Cardiac enzyme or marker:
Upper Limit of Normal
5. Did patient experience
ischemic symptoms?
6. Were there ECG changes consistent
ischemia?
If Yes, Date and Time of ECG
Provide details of ECG with most diagnostic changes: (If ‘9’, specify):
(If ‘9’, specify):
Complete Death Report CRF 99
Fax this form to the CCC Project Office within 48 hours of event.
MICHELANGELO:
STROKE REPORT
DataFax #135
Plate #040
Croatia
191
If Yes, Admission Date:
4. SYMPTOMS:( Mark [X] all symptoms present for >= 24 hours)
c) Ocular or visual symptoms (e.g. amaurosis fugax) 5. STATUS: (select single best description at 7 days or discharge,
whichever is earliest, after stroke onset)
e) Patient incapacitated, unable to perform c) Some functional impairment but patient Complete Death Report
6. BODY SIDE/VISUAL FIELD AFFECTED: (Mark [X] all that apply)
7. TREATMENT:
Mark [x] all that apply
a) Was the patient on any antithrombotic medications b) Did the patient undergo an invasive procedure within the 24 hours prior to onset of stroke- symptoms? 8. DIAGNOSTIC TESTS:
Was CT Scan/MRI done to confirm diagnosis? Yes specify
9. FINAL DIAGNOSIS: Mark [X] one box only
(definite confirmed by CT, MRI or autopsy) Fax this form to the CCC Project Office within 48 hours of event.
MICHELANGELO:
OASIS 5
REHOSPITALIZATION FOR UNSTABLE ANGINA
DataFax #135
Plate #050
Croatia
191
Use this form to report rehospitalizations for REFRACTORY/SEVERE ISCHEMIA after the initial hospital discharge.
Did the patient have at least 5 minutes of chest pain or other clinical symptoms of ischemia? 5. Was patient on optimal medical therapy (2 anti-anginal agents)? 6. Were there ECG changes consistent with ischemia? if ‘9’, specify:
8. Was thrombolytic therapy given to treat this event? MEDICAL THERAPY DURING HOSPITALIZATION: No
INTERVENTIONS DURING HOSPITALIZATION:
If Yes, complete report:
Complete CRF 15
Complete CRF 16 A&B
Complete CRF 17
REFRACTORY ISCHEMIA:
Did the chest pain/ischemic symptoms lead to an intervention within 48 hours of symptom onset? Fax this form to CCC Project Office within 48 hours of event
- REHOSPITALIZATION FOR UNSTABLE ANGINA- MICHELANGELO:
OTHER REHOSPITALIZATION REPORT
REHOSPIT
ALIZATION #
DataFax #135
Plate #055
Croatia
191
Use this form to report rehospitalizations OTHER than those for MI, STROKE, REFRACTORY/SEVERE ISCHEMIA
4. Main reason for admission: (Mark [x] only one box)
Other cardiac arrhythmias (specify) Complete CRF 15
Complete CRF 16 A&B
Complete CRF 17
Complete Bleeding
Report CRF 75
Complete SAE Report CRF 70
Other reason for admission (specify) Fax this form to the CCC Project Office within 48 hours of event
MICHELANGELO:
SERIOUS ADVERSE EVENT REPORT
SAE REPORT #
DataFax #135
Plate #070
Croatia
191
COMPLETE ONE SERIOUS ADVERSE REPORT FOR EACH SERIOUS ADVERSE EVENT REPORTED.
1. Adverse Event Diagnosis
2. Date of Onset of Adverse Event (1st symptom)
3. Detailed Description of Adverse Event (if applicable)
4. Intensity
5. Relationship to Study Drug:
Is there a reasonable possibility that the AE was caused by the study drug? 6. Action taken: Was study drug stopped due to this event?
7. Corrective Therapies
If Yes, specify:
8. Outcome of AE
Complete Death
Report CRF 99
9. Seriousness Criteria
Date when event became serious
(if different from onset date recorded above) ( mark [X] all that apply)
Persistent or significant disability or incapacity 10. Study drug administered within 24 hours of onset of SAE
11. List relevant concomitant medications taken within 3 days of this SAE:
12 List recent and relevant medical history and concomitant diseases not reported on CRF 4:
Fax SAE to CCC Project Office and Centre Monitor within 24 hours.
MICHELANGELO:
OASIS 5
SAE FOLLOW-UP REPORT
SAE Follow-up Report #
DataFax #135
Plate #071
Croatia
191
1. Date of Follow-up Evaluation:
2. Related SAE Report #
Fax SAE Complementary Form to CCC Project Office and Centre Monitor within 24 hours.
MICHELANGELO:
OASIS 5
CLINICALLY SIGNIFICANT BLEEDING REPORT
BLEEDING REPORT #
DataFax #135
Plate #075
Croatia
191
Complete DEATH REPORT CRF 99
4. Details of Bleeding: (Mark [X] all that apply)
(If Yes, complete Stroke Report CRF 40)
5. Was this bleeding event associated with any of the following? (Mark [X] all that apply)
6. Site/source: (mark [X] one box only) Surgical bleeding (beyond that expected from the procedure) 7. Treatment of Bleeding other than blood Transfusion: (Mark [X] all that apply)
8. Were any of the following investigations performed? (Mark [X] all that apply)
9. Indicate whether any of the following medications were taken by the patient a) < 24 hrs prior to bleeding event? 10. If considered serious bleeding, complete SAE Report CRF 70
Fax this form to the Project Office within 24 hours
MICHELANGELO:
OASIS 5
DEATH REPORT
DataFax #135
Plate #099
Visit #099
Croatia
191
2. Cause of death:(mark [X] only one box)
CARDIOVASCULAR
a) Cardiac:
Other (specify): __________________ b) Other Vascular:
Other (specify): ____________________________________ c) Unknown Cause:
NON-CARDIOVASCULAR: Record ONLY deaths due to documented non-vascular cause
(e.g., malignancy, trauma, infection) here.
(specify):______________________________________________________________ 3. Final Follow-up Visit (CRFs 12 and 13) completed:
4. Study Completion CRF 14 completed:
Fax this form to the Project Office within 48 hours of event

Source: http://saharaproject.ca/oasis5/Cro/CRFsCroatia.pdf