Serious Adverse Event Reporting

Serious Adverse Serious Adverse Event ReportingEvent Reporting

Start-up MeetingMarch 25, 2010Kingston, ON

ProceduresProcedures Using Pfizer ProductsUsing Pfizer Products MUSTMUST follow Pfizer SAE reporting follow Pfizer SAE reporting

policiespolicies

SAEs DefinedSAEs Defined Any untoward medical occurrence that Any untoward medical occurrence that at at

any doseany dose results in: results in: DeathDeath Is life-threateningIs life-threatening Requires in-patient hospitalization or prolongs Requires in-patient hospitalization or prolongs

hospitalizationhospitalization Results in persistent or significant Results in persistent or significant

disability/incapacitydisability/incapacity Is a congenital anomaly or birth defectIs a congenital anomaly or birth defect An important medical eventAn important medical event

SAE Manual pg. 4-5

When to report:When to report:

SAE CriteriaReportable (x)

Expected

Unexpected

Death x xLife-threatening xHospitalization xDisability/Incapacity xCongenital anomaly, birth defect

x

Important medical event

x

UNEXPECTEDAn event that is not expected due to the progression of underlying disease or co-

morbid illnesses.

SAE Reports to:SAE Reports to:

Pfizer Canada Drug Safety Group

AND

A copy sent to CERU Project Leader

SAE Manual pg. 7

Reporting TimelinesReporting Timelines From the time the patient receives From the time the patient receives

the first dose until 28 days following the first dose until 28 days following the last dosethe last dose

SAE Manual pg. 6

Consent Obtained

Last Dose of

Investigational ProductRandomizat

ion

28 days post last

dose of IP28 days

Report all SAEs to Pfizer & CERU

14 days

Initial Reports - TimingInitial Reports - Timing Fatal & Life-threatening: Fatal & Life-threatening:

IMMEDIATELYIMMEDIATELY

All other SAEs: within 24 hours of All other SAEs: within 24 hours of awareness of the occurrence of the awareness of the occurrence of the eventevent

SAE Manual pg. 6

SAE Report FormsSAE Report Forms

SAE Manual, Appendix A & B

Minimum required Minimum required informationinformation

1. Identifiable Patient

Minimum required Minimum required informationinformation

2. Suspect Product

Minimum required Minimum required informationinformation

3. SAE (diagnosis or signs & symptoms)

Minimum required Minimum required informationinformation

4. Identifiable reporting source

Causality AssessmentCausality AssessmentA determination of whether or not there is a

reasonable possibility that the blinded therapy is caused or contributed to the SAE.

OR

•Concomitant medications

•Background treatment

•Comorbidities

•Study procedures

•Other

YES

NO

SAE Manual pg. 7

Follow-up InformationFollow-up Information New, updated or corrected New, updated or corrected

information to a previously information to a previously submitted report:submitted report: Missing or incomplete info at time of Missing or incomplete info at time of

initial reportinitial report Info not previously availableInfo not previously available Changes or clarificationsChanges or clarifications Additional information as requested by Additional information as requested by

Pfizer or CERUPfizer or CERU

Site completes an initial report using Pfizer SAE Report Form

Sends report to: Pfizer AND CERU

Site identifies a reportable SAE

Site reports SAE to local REB as per local

requirements

Pfizer will correspond with site until report is

complete

If event is casually related to IP, CERU must report to Health Canada:

•Death or Life-threatening = 7 calendar days

•All other SAEs = 15 calendar days

CERU will correspond with the site until report is complete.

Causally related to IP?

YES & NO

YES

CERU will send completed report to all participating sites. Site to submit to local REB.

UnblindingUnblinding

If there are concerns regarding the If there are concerns regarding the investigational product, stop the product investigational product, stop the product and complete a Protocol Violation Formand complete a Protocol Violation Form

If unblinding is required procedures If unblinding is required procedures outlinedoutlined

SAE Manual pg. 9

There is no known antidote for the investigational products