PATIENT ID
Study Drug: Renis/Afinitor
Study/Protocol
No:
REPORT TYPE
CRAD001LCZ01T
Initial
Patient’s Initials
1.
If applicable
2.
Centre No.
Follow-Up
fam.
Patient No
Page 1 of 3
POST- MARKETING SURVEILLANCE STUDY PREGNANCY FORM
1. Country:
Czech Republic
2. LOCAL CASE ID:
I.
MATERNAL INFORMATION
3. DATE OF BIRTH
day
month year
4.
AGE
yrs./mo.
5. RACE
Caucasian
6. HEIGHT
Black
8.
Date of Last Menstrual Period
10.
Method of Contraception
day
month
cm
Other
year
9.
Expected Date of Delivery
11.
kg
day
month
year
Contraception used as instructed
yes
II.
7. WEIGHT
Oriental
no
uncertain
HISTORY
PATIENT’S PAST MEDICAL HISTORY (include information on familial disorders, known risk factors or conditions that may affect the outcome
of the pregnancy e.g. alcohol, smoking, other substance consumption, hypertension, eclampsia, diabetes including gestational, infections
during pregnancy, environmental or occupational exposure that may pose a risk factor).
12.
PREVIOUS OBSTETRIC HISTORY – provide details on all previous pregnancies below, including abortion or stillbirth (use page 3 if
needed)
13.
Gestation week
Outcome including any abnormalities
1
2
3
4
14.
DRUG INFORMATION – please list the Novartis drug(s) first and all other therapies taken prior to or during pregnancy
Drug Names
Daily Dose
Treatment Dates
Start
Stop
Route
Indication
(specify week of pregnancy)
Start
Stop
MANUFACTURER INFORMATION (FOR INTERNAL USE ONLY)
15. DATE MANUFACTURER NOTIFIED
day
17. NAME AND ADDRESS OF REPORTING MANUFACTURER
Novartis s.r.o.,
GEMINI budova B,
Na Pankraci 1724/129
140 00 Praha 4 - Nusle
l
month
year
16. DATE OF THIS REPORT
month
year
PLEASE FILL IN THE CORRECT CS&E ADDRESS
PLEASE SEND FORM TO LOCAL DSE Dept., Novartis, fax: 225 775 205
Annex 3b – Afinitor
Post-Marketing Surveillance Study Pregnancy Form/ 2011
day
PATIENT ID
Study Drug: Renis/Afinitor
Study/Protocol
No:
REPORT TYPE
CRAD001LCZ01T
Initial
Patient’s Initials
1.
If applicable
2.
Centre No.
Follow-Up
fam.
Patient No
Page 2 of 3
POST- MARKETING SURVEILLANCE STUDY PREGNANCY FORM
2. LOCAL CASE ID:
III.
PREGNANCY INFORMATION
18.
PRENATAL
Have any specific tests, e.g. amniocentesis, ultrasound, maternal serum AFP, been performed during the pregnancy so far?
No
Yes
Not known
If yes, please specify test date and results:
19.
PREGNANCY OUTCOME
Delivery
Normal
Forceps/Ventouse
Caesarean section
Maternal complications or problems related to birth: ________________________________________
Abortion
Therapeutic
Planned
Spontaneous
Please, specify reason and any abnormalities (if known) ________________
Unspecified
____________________________________________________________
Date of abortion/delivery
at week _______
20.
day
month
year
MATERNAL PREGNANCY ASSOCIATED EVENTS:
If the mother experiences a serious adverse drug reaction (ADR) during a pregnancy, please complete a SAE form and submit as requested
IV.
21.
CHILD INFORMATION
Neonate
Normal
Abnormal
Sex
Stillbirth
Height
please specify any abnormalities: ______________________________
Weight
Apgar Scores
Head circumference
1 min.
5 mins.
Female
cm
kg
10 mins.
For additional information, please use page 3 (please provide copies of relevant documentation)
Male
V.
22.
cm
ASSESSMENT OF PREGNANCY OUTCOME
SERIOUSNESS CRITERIA
Non Serious
day
month year
day
Mother died
Stillbirth / Neonate died
Involved or prolonged inpatient hospitalisation
Life-threatening
month year
Results in persistent or significant disability/incapacity
Other Seriousness Criteria:
23.
Congenital anomaly/birth defect
Other significant medical events
ASSESSMENT OF CAUSALITY
Please indicate the relationship between pregnancy outcome and Novartis study drug
Not suspected
Suspected
INFORMATION SOURCE
24 NAME, ADDRESS AND TELEPHONE NUMBER OF INVESTIGATOR
25.: . REPORTING DATE BY INVESTIGATOR/PERSON
REPORTING EVENT
day
Signature:
PLEASE SEND FORM TO LOCAL DSE Dept., Novartis, fax: 225 775 205
Signature:
Annex 3b – Afinitor
Post-Marketing Surveillance Study Pregnancy Form/ 2011
month
year
Study Drug: Renis/Afinitor
Study/Protocol
No:
PATIENT ID
REPORT TYPE
CRAD001LCZ01T
Initial
Patient’s Initials
If applicable
1.
Centre No.
2.
Follow-Up
fam.
Patient No
Page 3 of 3
POST-MARKETING SURVEILLANCE STUDY PREGNANCY FORM
2. LOCAL CASE ID:
FOR ADDITIONAL INFORMATION:
INFORMATION SOURCE
32. NAME, ADDRESS AND TELEPHONE NUMBER OF INVESTIGATOR
33. REPORTING DATE BY INVESTIGATOR/PERSON REPORTING
day
Signature:
PLEASE SEND FORM TO LOCAL IMS Dept., Novartis, fax: 225 775 205
Annex 3b – Afinitor
Post-Marketing Surveillance Study Pregnancy Form/ 2011
month
year