ON – Current status

Novartis Pharmaceuticals Corporation

59 Route 10

East Hanover, NJ 07936

Appendix 8:
Patient Information Form
(Bisphosphonates and ONJ)

Zometa^® (zoledronic acid) Injection

and

Aredia^® (pamidronate disodium) Injection

Submitted: February 1, 2005

Oncologic Drugs Advisory Committee Meeting

March 4, 2005

Property of Novartis Pharmaceuticals Corporation
All rights reserved
Available for public disclosure without redaction

Patient Demographics
Date of Birth:
	day	month	year	Age
Gender:	£Male £ Female
Adverse Event Report:

Drug Information
Drug Name	Therapy Dates		Indication(s)	Dosing at time of event
Drug Name	From	To	Indication(s)	Dose	Formulation	Frequency
Aredia
Zometa

Oral Surgeon/ Dentist:		Name/Title:
		Address:

		Telephone:
Oncologist:		Name/Title:
		Address:

		Telephone:
Other Healthcare Professional:		Name/Title:
		Address:

		Telephone:
	General Medical History / Medical Conditions / Medical Procedures
	List relevant medical history, medical conditions, and medical procedures with special attention to the following (use page 4 for dental history and page 6 for cancer history): Vascular disorders (e.g., injury, vessel compression) £No £Yes (specify below) Coagulation disorders (e.g, DVT, embolism, hemophilia) £No £Yes (specify below) Metabolic / Endocrine disorders (including Diabetes) £No £Yes (specify below) Alcoholism £No £Yes (specify below) Anemia £No £Yes (specify below) Asthma / Lung Disease £No £Yes (specify below) Autoimmune / Rheumatoid Disease £No £Yes (specify below) Smoking £No £Yes (specify below) Chronic Renal Failure £No £Yes (specify below)
	History / Condition / Procedure				Date		Ongoing problem?
							Yes		No
							Yes		No
							Yes		No
							Yes		No
							Yes		No
							Yes		No
							Yes		No
							Yes		No
							Yes		No
‘Background’ Medications – Including Bisphosphonate Use (within 24 Months prior to diagnosis of Osteonecrosis)
List medications with special attention to the following (use page 5 for dental medications and page 7 for oncology medications): Corticosteroids £No £Yes (specify below) Pamidronate / Aredia^®£No £Yes (specify below) Zoledronic acid / Zometa^®£No £Yes (specify below) Other Bisphosphonates £No £Yes (specify below)
Medication			Dose & Regimen	Indication		Date Started		Date Stopped

Dental History / Dental Conditions
Please list relevant dental history and dental conditions with special attention to the following: Dental conditions (e.g., dental & sinus infections, mucositis,oral complications due to chemotherapy) £No £Yes (specify below) Dental Procedures (e.g., dental extractions, maxillofacial surgeries £No £Yes (specify below)) History of trauma or fractures of the Jaw (include trauma due to dental bridgework, dentures, etc.) £No £Yes (specify below)
History / Medical condition	Date of Diagnosis / Procedure	Ongoing problem?
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No
		Yes	No

Osteonecrosis of the Jaw: Diagnosis & Treatment (if multiple dates of diagnosis are present, this page may be photocopied for additional use)
Diagnosis (type of osteonecrosis)
Date of Diagnosis
Anatomical Site(s)
Concurrent Factors (e.g., tooth extraction, other dental procedures)
Method of Diagnosis	£ Clinical
	£ Imaging (specify)
	£ Biopsy (specify)
	£ Other (specify)
Treatment
Date(s) of Treatment
Outcome	£ Resolved (specify date) £ Treatment ongoing £ Unknown

Dental Medications & Treatments
Please list current dental medication/treatments with special attention to the following: Use of anesthetics in dental procedures (especially those with £No £Yes (specify below) vasoconstrictors) Antibiotics £No £Yes (specify below)
Medication/Treatment	Dose & Regimen	Indication	Date Started	Date Stopped

Cancer Diagnosis
Type of Cancer (Include Staging Details)	Date of Diagnosis

Radiation Therapy
£None £Yes (specify below)
Location	Dose & Regimen	Indication	Date Started	Date Stopped

Oncology Medications (within 24 Months prior to diagnosis of Osteonecrosis)
List oncology medications with special attention to the following: Chemotherapy £No £Yes (specify below) Corticosteroids £No £Yes (specify below)
Medication	Dose & Regimen	Indication	Date Started	Date Stopped

Healthcare Professional reporter information

Name ____________________________ Specialty__________________________

Signature__________________________ Date_____________________________

Prepared by_________________________________