SAE report

SAE BR29-CAXX410-SAE01-F1

Date of Event/Reporting Period

Date of event:
15 Jan 2009
Date event known to investigator:
15 Jan 2009
Temporal relation of SAE to protocol treatment:
During protocol treatment
If During Protocol Treatment, please indicate Reporting Period at which SAE occurred:
1

Event Description

Free text, to be entered by centre

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Reason Serious

Definition of "Serious" Adverse Event (check all that apply)

Fatal
Life Threatening
Leads to or prolongs existing hospitalization
Results in persistent or significant disability / incapacity
Congenital anomaly / birth defect
Required intervention / important medical event
Second malignancy

Serious Adverse Events

CTCAE V3.0 Short Name CTCAE V3.0 Sub-term (if applicable) Date of Onset Date of Resolution Worst Grade Relation to ____ Relation to _______ Relation to _______ Action Required (Protocol Therapy) Outcome (Adverse Event)
2 Heartburn 12 Jan 2009 3 Definite Definite Definite Dose reduced Event ongoing

"Expectedness - NCIC CTG USE ONLY"

Autofill events from SAE Form?Yes
CTCAE V3.0 Short Name CTCAE V3.0 Sub-term (if applicable) Agent Is AE listed in protocol consent for this agent? Is AE listed in MEE for this agent? Is AE listed in IB/PM for this agent?
Heartburn carboplatin No No No

Laboratory Tests - Question

Are there any relevant laboratory or physical exam tests to report?

Yes
Test Specify Worst (Nadir) at Time of Serious Adverse Event - Value Date of Worst Value Recovery Value Date of Recovery Value
Bilirubin 20 12 Jan 2009 15 15 Jan 2009

Other Investigations - Question

Are there any other relevant investigations to report?

Yes
Test Specify Date Result
CT scan chest 15 Jan 2009 Negative
CT scan pelvis 15 Jan 2009 Positive

Protocol Treatment

Agent Actual Dose Units Route Schedule Start Date This Reporting Period Date of Last Dose Prior to SAE Source of Agent Patient Rechallenged With Agent? Did Event Reoccur?
Cediranib / Placebo 20 1 Per os (by mouth, oral) 1 10 Jan 2009 14 Jan 2009 1 Yes No

Disease Information

Malignancy:lun
Site of Metastatic Disease Specify
Lung

Prior Systemic Therapy - Baseline Question

Has the patient had any prior radiation therapy for study disease?
No
If Yes, have you completed the Prior Radiation Therapy Form in Baseline Folder?

Prior Radiation Therapy - Baseline Question

Has the patient had any prior systemic therapy for study disease?
No
If Yes, have you completed the Prior Systemic Therapy Form in Baseline Folder?

Relevant Major Medical Problems - Question

Are there any relevant major medical problems to report?

Yes
Date Documented Major Medical Problem Other Relevant Details

Concomitant Medications - Question

Was the patient receiving concomitant medications at the time of event? (Note: This includes any medications given to treat SAE.)

Yes
If Yes, have you updated the Concomitant Measures/Medications Running Log Form?Yes
Treatment Name Reason for Use Specify Was This Measure/Medication Used to Treat the SAE? Start Date Stop Date
ASPIRIN Hypertension No 12 Jan 2009
FLOMAX Other OTH Prostate Yes 15 Dec 1999
TYLENOL #3 Analgesic Yes 01 Jan 2009

SAE Notification Form

Report Name of Individual Completing this Report Description of Changes Notify NCIC CTG of this Event
Initial davidg Initial Yes

Folder Completion

Report Name of Individual Completing this Report Date Completed Notify NCIC CTG of this event?
IN davidg 12 Jan 2009 Yes

NCIC CTG Use Only - Summary

Date CTG first notified of SAE:(by phone, by manual e-mail or by automatic e-mail)

16 Jan 2009

Does this event meet SAE reporting criteria as defined in protocol section 11?

Yes

SAE first identified by:

Investigator

CTG SUMMARY OF EVENT NOTE:This summary will be used for Meeting Book tables, and for Health Canada reporting if applicable.For IND Studies, summary must be in standard format and must include title of event, age, gender, diagnosis (for phase 1 studies), extent of disease (eg, with liver, lung and bone metastases), start date of protocol therapy and/or date of last treatment, dose and schedule of study drug, date and detailed description of event, including relevant investigations, treatment given for SAE, other concomitant meds/measures if relevant, treatment modifications if applicable, outcome of event, and relation to protocol therapy (by agent, if applicable). For Phase III Studies, preliminary summary may be less comprehensive, but must be in standard format and must include title of event, age, gender, a brief description of event, and relation to protocol therapy (by agent, if applicable). Summary may need to be expanded following PC review if event is deemed HC reportable.For ALL studies, NCIC CTG Summary of Event must be updated by SC whenever significant new information is received.

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Report Status

Interim

NCIC CTG Use - SC Review

Report SC User Name Date Reviewed Description of Changes Generate SAE Data Report for PC Review SAE ID:
Initial davidg 12 Jan 2009 Initial Yes BR29-CAXX410-SAE01-IN
Update 1 davidg 13 Jan 2009 Follow up 1 Yes BR29-CAXX410-SAE01-F1

NCIC CTG Use - Monitor Review

Report Monitor User Name Date Reviewed

SAE - Confirmation

Please confirm that you would like to add a Serious Adverse Event Report Folder:
Yes