STUDY/PROTOCOL:CRAD001LCZ01T
COUNTRY:CZ / PATIENT ID:Patient’s initials: / NOVARTIS
POSTMARKETING
STUDY
SERIOUS ADVERSE EVENT (SAE) REPORT FOR POSTMARKETING SURVEILLANCE STUDIES / Page 1 of 2
1. REPORT TYPE: / Initial / Follow-up
I. / SERIOUS ADVERSE EVENT INFORMATION
2.DATE OF BIRTH / 3.AGE / 4. RACE / 5.SEX / 6. HEIGHT / 7. WEIGHT / 8. ONSET OF FIRST
daymonthyear / yrs./mo. / Caucasian / Oriental / Male / SIGN/SYMPTOM
OF SAE
Black / Other / Female / cm / kg / daymonthyear
9. SERIOUS ADVERSE EVENT(S) IN MEDICAL TERMS (diagnosis, if possible) / SERIOUSNESS CRITERIA
10. CHECK ALL APPROPRIATE TO EVENT
Description of event: / Patient died / daymonthyear
Involved or prolonged inpatient hospitalization
Involved persistent or significant disability or incapacity
Life-threatening
Other Seriousness Criteria:
Congenital anomaly/birth defect
Other significant medical events
II. / DRUG INFORMATION
11. DOSES AT OR BEFORE ONSET OF SAE / 12. ROUTE OF / 13. THERAPY DATES (from / to)
(total daily dose) / ADMINISTRATION / daymonthyear / daymonthyear
14. INDICATION FOR STUDY DRUG
III. / HISTORY
15. PATIENT’S RELEVANT MEDICAL HISTORY (e.g. co-existing medical conditions such as disease, allergies, similar experiences)
IV. / MANUFACTURER INFORMATION (FOR INTERNAL USE ONLY)
16. DATE MANUFACTURER NOTIFIED OF SAE / day / month / year / 17. DATE OF THIS REPORT / day / month / year
18. NAME AND ADDRESS OF REPORTING MANUFACTURER
Novartis s.r.o.,
GEMINI Budova B
Na Pankráci 1724/129
140 00 Praha 4 / PLEASE FILL IN THE CORRECT LOCAL CS&E ADDRESS
STUDY DRUG: RENIS/Afinitor
STUDY/PROTOCOL: CRAD001LCZ01T
COUNTRY:CZ / PATIENT ID:Patient’s initials: / NOVARTIS
POSTMARKETING
STUDY
SERIOUS ADVERSE EVENT (SAE)REPORT FOR POSTMARKETING SURVEILLANCE STUDIES / Page 2 of 2
19. CONCOMITANT DRUGS RELEVANT TO THE SAE (exclude therapy to treat SAE)
DRUG NAME(S) / DOSE / THERAPY DATES / REASON
FOR USE
COMMENT: If the adverse event was related to a concomitant medication, please note it here.
20. ACTION TAKEN (mark all as appropriate)
No Action Taken / Study drug permanently discontinued due to this adverse event / Concomitant medication taken
Study Drug dosage adjusted/temporarily interrupted * / Non-drug therapy given ** / Hospitalization/prolonged hospitalization
*If ticked, enter new dosage information in field 9
**If ticked, provide therapeutic measures in field 9
21. / TEST / LABORATORY FINDINGS (enter only those findings necessary for SAE diagnosis or course description)
22. OUTCOME OF THE PATIENT/SAE
Completely Recovered / Date of recovery: / DayMonthYear / Condition still present and unchanged
Recovered with sequelae / Condition deteriorated
Condition improving / Death Autopsy: No Yes
23. ASSESSMENT OF CAUSALITY
Relationship to study drug / Not suspected / Suspected
V. / INFORMATION SOURCE
24. NAME, ADDRESS AND TELEPHONE NUMBER OF INVESTIGATOR
Signature: / 25. REPORTING DATE BY INVESTIGATOR/PERSON REPORTING EVENT
daymonthyear
CZECH REPUBLIC: PLEASE FAX FORM TO DSE Dept., Novartis s.r.o. Pharma, No: 225775205
Supplement No 3 – WP RENIS/Afinitor, version 1/2011