CIOMS Report

CIOMS FORM
DE-BFARM-16052057
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS 1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
2a. AGE 3. SEX
YR
21
(Year)
4-6 REACTION ONSET 8-12 CHECK ALL
APPROPRIATE TO
DA
MO
YR
ADVERSE REACTION
Female
2015
¨ PATIENT DIED
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
Haarbruch [ MedDRA 18.1 LLT (10056820): Hair breakage ]
Sexuelle Unlust [ MedDRA 18.1 LLT (10024419): Libido decreased ]
Erhötes Wachstum meines Angiolipoms [ MedDRA 18.1 LLT (10001484): Aggravation of
existing disorder ]
¨
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
¨
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
Bericht des Meldenden:
Ich habe die Pille weiterhin eingenommen bis ich bemerkt habe, dass mein starker Haarbruch
nur durch die Pille kommen kann da ich auch schon meine Ernährung umgestellt habe etc.
Hinzu kommt das ich 2015 nun schon 2 OPs an meinem Angiolipom hatte die OP davor lag
mehrere Jahre zurück! D.h. das Angilipom ist DEUTLICH schneller mit der Pille Mayra
gewachsen als zuvor. ( Ich hatte vorher die Pille Maxim und mit der hatte ich keine Probleme).
¨LIFE THREATENING
CONGENITAL
/ BIRTH
¨ANOMALY
DEFECT
OTHER MEDICALLY
þIMPORTANT
CONDITION
II. SUSPECT DRUG(S) INFORMATION
(cont.) 20. DID REACTION ABATE
14. SUSPECT DRUG(S) (include generic name)
AFTER STOPPING DRUG?
mayra
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
"daily dose: 1 Df dosage form every Day" { 1 Df dosage
form, 1 in 1 Day }
Oral
¨YES ¨NO ¨NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
17. INDICATION(S) FOR USE
¨YES ¨NO ¨NA
Contraception
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 2015
1 Year
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.)
(cont.)
[ MedDRA 18.1 (10048945): Angiolipoma ]
Continuing: Unknown
[ MedDRA 18.1 (10042609): Surgery ] from 2015 Continuing: Unknown
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-16052057
24c. DATE RECEIVED BY 24d. REPORT SOURCE
MANUFACTURER
STUDY
LITERATURE
17-FEB-2016
DATE OF THIS REPORT
17-FEB-2016
¨
¨
HEALTH
PROFESSIONAL
¨
25a. REPORT TYPE
þINITIAL ¨FOLLOW UP ¨FINAL
(Cont.) = Continuation on attached sheet(s)
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date: 17-FEB-2016
DE-BFARM-16052057
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Reaction text as reported
MedDRA coding
(... continuation ...)
Outcome*
Term highlighted
Duration
Report Page: 2 o f 4
Time interval 1**
Time interval 2*** Start date
End date
Haarbruch
[MedDRA 18.1 PT (10044625):
Trichorrhexis ]
Unknown
2015
Unknown
2015
Unknown
2015
[ MedDRA 18.1 LLT
(10056820): Hair breakage ]
Sexuelle Unlust
[MedDRA 18.1 PT (10024419):
Libido decreased ]
[ MedDRA 18.1 LLT
(10024419): Libido decreased
]
Erhötes Wachstum meines Angiolipoms
[MedDRA 18.1 PT (10010264):
Condition aggravated ]
[ MedDRA 18.1 LLT
(10001484): Aggravation of
existing disorder ]
* 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
Start
mayra
2015
Unit
Normal low
Normal high
More inform.
(... continuation ...)
End
Identification of the country
where the drug was obtained
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
Duration
Dose *
Route(s) of
1 Year
A: daily dose: 1 Df Oral
dosage form every
Day
B:
C: 1Df dosage form
D: 1
E: 1Day
Indication(s)
Contraception
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date: 17-FEB-2016
DE-BFARM-16052057
Report Page: 3 o f 4
Time interval between last dose
of drug and start of reaction/event
Action(s) taken with drug
Additional information on drug
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
23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date End date
[ MedDRA 18.1 (10048945): Angiolipoma ]
Continuing Comments
Unknown
[ MedDRA 18.1 (10042609): Surgery ]
2015
Unknown zweimalige Operation wegen
Angiolipom
Report duplicates
Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2016011410
Patient past drug therapy
Name of drug as reported
Maxim
Indication MedDRA code
Reactions MedDRA code
[ MedDRA 18.1 (10010808):
Contraception ]
[ MedDRA 18.1 (0): unbekannt ]
Parent
Parent identification Date of birth
Age
LMP date
0
ADMINISTRATIVE AND IDENTIFICATION INFORMATION
Safetyreportversion
1
Identification of the country where the
Deutschland
Serious
Yes
Date Format of receipt of the most recent
information for this report
20160217
Additional documents
No
List of documents held by sender
Does this case fulfill the local criteria for an
expedited report?
Regulatory authority's case report number
Yes
Weight(kg) Height(cm) Sex
Start date End date
Text for relevant medical history
and concurrent conditions
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date: 17-FEB-2016
DE-BFARM-16052057
Report Page: 4 o f 4
DE-CADRBFARM-2016011410
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
42
Consumer or
other non health
professional
Deutschland
Literature reference(s)
SENDER INFORMATION (... continuation ...)
Type
Regulatory Authority
Organisation
BfArM
Department
Pharmakovigilanz
Street address
Kurt-Georg-Kiesinger-Allee 3
City
Bonn
Postcode
53175
Country
Deutschland
Fax
Telephone
E-mail address
pharmakovigilanz@bfarm.de
PATIENT INFORMATION (... continuation ...)
Investigation number
Gestation period
Patient age group
Adult
Weight (kg)
61
Height (cm)
170
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
>18.Lj. bis einschl. 65.Lj.
Sponsor study number
Study type in which
the reaction(s)/event(s)
were observed