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CIOMS FORM
DE-BFARM-16070581
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
33
(Year)
3. SEX
Female
4-6 REACTION ONSET
DA
MO
YR
19
07
2014
8-12 CHECK ALL
APPROPRIATE TO
ADVERSE REACTION
¨ PATIENT DIED
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
Beidseitige Lungenembolie [ MedDRA 18.1 LLT (10037377): Pulmonary embolism ]
kurzzeitiger Herzstillstand [ MedDRA 18.1 LLT (10007515): Cardiac arrest ]
[ MedDRA 18.1 LLT (10004982): Blackout ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
Nach 6 Monaten Antibabypille beidseitige Lungenembolie mit Bewusstlosigkeit und kurzzeitigem
Herzstillstand. Behandlung mit Spritzen und Marcumar auf der Intensivstation. Keine
Gerinnungskrankheiten diagnostiziert.
þ
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION
¨
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
þ LIFE THREATENING
¨
CONGENITAL
ANOMALY / BIRTH
DEFECT
þ
OTHER MEDICALLY
IMPORTANT
CONDITION
II. SUSPECT DRUG(S) INFORMATION
(cont.) 20. DID REACTION ABATE
14. SUSPECT DRUG(S) (include generic name)
AFTER STOPPING DRUG?
Maxim
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
"täglich"
Oral
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
¨ YES ¨ NO ¨ NA
Bleeding menstrual heavy
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 15-JAN-2014
6 Month
III. CONCOMITANT DRUG(S) AND HISTORY
22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.)
IV. SENDER INFORMATION
24a. NAME AND ADRESS OF SENDER
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
24b. MFR CONTROL NO.
DE-BFARM-16070581
24c. DATE RECEIVED BY
MANUFACTURER
03-MAR-2016
DATE OF THIS REPORT
03-MAR-2016
24d. REPORT SOURCE
¨ STUDY ¨ LITERATURE
¨ HEALTH PROFESSIONAL
25a. REPORT TYPE
þ INITIAL ¨FOLLOW UP ¨ FINAL
(Cont.) = Continuation on attached sheet(s)
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16070581
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Reaction text as reported
MedDRA coding
Duration
Beidseitige Lungenembolie
[MedDRA 18.1 PT (10037377):
Pulmonary embolism ]
Report Date:
03-MAR-2016
Report Page:
2 of 4
(... continuation ...)
Outcome*
Term highlighted
Time interval 1**
Time interval 2*** Start date
Unknown
6 Month
19-JUL-2014
Unknown
6 Month
19-JUL-2014
Unknown
6 Month
19-JUL-2014
End date
[ MedDRA 18.1 LLT
(10037377): Pulmonary
embolism ]
kurzzeitiger Herzstillstand
[MedDRA 18.1 PT (10007515):
Cardiac arrest ]
[ MedDRA 18.1 LLT
(10007515): Cardiac arrest ]
[MedDRA 18.1 PT (10024855):
Loss of consciousness ]
[ MedDRA 18.1 LLT
(10004982): Blackout ]
* Outcome of reaction/event at the time of last observation
** Time interval between beginning of suspect drug administration and start of reaction/event
*** Time interval between last dose and start of reaction/event
Results of tests
Date
Test
Result
14. Suspect Drug(s) (including generic name)
Suspect Drug
and batch no.
Start
date
Maxim
15-JAN2014
End
date
Name of holder/applicant
Authorization/Application Number
Country of authorization/application
Pharmaceutical form (Dosage form)
Parent route of administration
(in case of a parent child/fetus report)
Gestation period at time of exposure
Time interval between beginning of drug
administration and start of reaction/event
Action(s) taken with drug
Additional information on drug
Normal low
range
Normal high
range
More inform.
available
(... continuation ...)
Identification of the country
where the drug was obtained
Time interval between last dose
of drug and start of reaction/event
Unit
Duration
Dose *
Route(s) of
Administration
Indication(s)
6 Month
A: täglich
B:
C:
D:
E:
Oral
Bleeding menstrual
heavy
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16070581
Report Date:
03-MAR-2016
Report Page:
3 of 4
Did reaction reappear after reintroduction?
* A: Dosage Text
B: Cumulative dose number (to first reaction)
C: Structure dosages number
D: Number of separate dosages
E: Number of units in the interval
Active drug substance name
ethinylestradiol
dienogest
Report duplicates
Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2016011781
Parent
Parent identification Date of birth
Age
LMP date
Weight(kg) Height(cm) Sex
Text for relevant medical history
and concurrent conditions
0
ADMINISTRATIVE AND IDENTIFICATION INFORMATION
Safetyreportversion
1
Identification of the country where the
reaction/event occur
Deutschland
Serious
Yes
Date Format of receipt of the most recent
information for this report
20160303
Additional documents
No
List of documents held by sender
Does this case fulfill the local criteria for an
expedited report?
Yes
Regulatory authority's case report number
DE-CADRBFARM-2016011781
Other case identifiers in previous
transmissions
Yes
Was the case medically confirmed, if not
initially from health professional?
No
Primary source(s) of information
Study name
Reporter postcode Reporter country
Qualification
71
Consumer or other
non health
professional
Deutschland
Literature reference(s)
SENDER INFORMATION (... continuation ...)
Type
Regulatory Authority
Organisation
BfArM
Sponsor study number
Study type in which the
reaction(s)/event(s)
were observed
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16070581
Department
Pharmakovigilanz
Street address
Kurt-Georg-Kiesinger-Allee 3
City
Bonn
Postcode
53175
Country
Deutschland
Fax
Telephone
E-mail address
[email protected]
PATIENT INFORMATION (... continuation ...)
Investigation number
Gestation period
Patient age group
Adult
Weight (kg)
85
Height (cm)
163
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
>18.Lj. bis einschl. 65.Lj.
Report Date:
03-MAR-2016
Report Page:
4 of 4