CIOMS Report

CIOMS FORM
DE-BFARM-16123733
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
29
(Year)
3. SEX
Female
4-6 REACTION ONSET
DA
MO
YR
25
03
2016
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
(cont.)
[ MedDRA 18.1 LLT (10006299): Breast pain female ]
Einseitige enorme Brustschwellung durch eine sehr starke Vergrößerung der Brustdrüsen nach
Einnahme der Pille [ MedDRA 18.1 LLT (10006312): Breast swelling ]
Probleme beim Atmen [ MedDRA 18.1 LLT (10038683): Respiratory disorder ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
Bericht des Meldenden:
Verschreibung der Pille "Diane" aufgrund von Hautproblemen.
Nach ca. 2 Wochen nach Einnahme der Pille hatte ich leichte Schmerzen in der rechten Brust beim
Daraufliegen.
Nach ca. 3 1/2 Wochen ist meine Brust innerhalb von 2 Tagen derart angeschwollen (um das 2
fache),dass Liegen, Anziehen, jegliche Bewegung unmöglich wurde. Ich konnte kaum noch atmen,
da ich das Gefühl hatte meine Brust "platzt". Der Arzt hatte einen Verdacht auf eine Zyste, da eine
einseitige Vergrößerung atypisch sei. Es stellte sich heraus, dass meine Brustdrüsen hormonell
bedingt um das 3 fache vergrößert waren. Eine solch derartige Schwellung hat die Ärztin lange
nicht gesehen. Nun werde ich behandelt mit einer Hormonsalbe und leide immer noch unter
8-12 CHECK ALL
APPROPRIATE TO
ADVERSE REACTION
¨ PATIENT DIED
¨
INVOLVED OR
PROLONGED
INPATIENT
HOSPITALISATION
¨
INVOLVED
PERSISTENCE OR
SIGNIFICANT
DISABILITY OR
INCAPACITY
¨ LIFE THREATENING
¨
CONGENITAL
ANOMALY / BIRTH
DEFECT
¨
OTHER MEDICALLY
IMPORTANT
CONDITION
II. SUSPECT DRUG(S) INFORMATION
(cont.) 20. DID REACTION ABATE
14. SUSPECT DRUG(S) (include generic name)
AFTER STOPPING DRUG?
diane
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
"daily dose: 1 Df dosage form every Day" [ 24 Df dosage
form { 1 Df dosage form, 1 in 1 Day } ]
Oral
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
¨ YES ¨ NO ¨ NA
Contraception
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 02-MAR-2016
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.)
[ MedDRA 18.1 (10040831): Skin disorder ]
(cont.)
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-16123733
24c. DATE RECEIVED BY
MANUFACTURER
15-APR-2016
DATE OF THIS REPORT
15-APR-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-16123733
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Report Date:
15-APR-2016
Report Page:
2 of 4
(... continuation ...)
Schmerzen!
Reaction text as reported
MedDRA coding
Outcome*
Term highlighted
Duration
Time interval 1**
Time interval 2*** Start date
End date
Einseitige enorme Brustschwellung durch eine sehr starke Vergrößerung der Brustdrüsen nach Einnahme der Pille
[MedDRA 18.1 PT (10006312): 10 Day
Unknown
24 Day
25-MAR-2016
04-APR-2016
Breast swelling ]
[ MedDRA 18.1 LLT
(10006312): Breast swelling ]
[MedDRA 18.1 PT (10006298): 11 Day
Breast pain ]
not recovered/not
resolved
2 Week
25-MAR-2016
04-APR-2016
[ MedDRA 18.1 LLT
(10006299): Breast pain female
]
Probleme beim Atmen
[MedDRA 18.1 PT (10038683):
Respiratory disorder ]
Unknown
25-MAR-2016
[ MedDRA 18.1 LLT
(10038683): Respiratory
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
and batch no.
Start
date
diane
02-MAR2016
Unit
Normal low
range
Normal high
range
More inform.
available
(... continuation ...)
End
date
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
Administration
A: daily dose: 1 Df Oral
dosage form every
Day
B: 24Df dosage
form
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
DE-BFARM-16123733
Report Date:
15-APR-2016
Report Page:
3 of 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
cyproterone acetate
23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date End date
[ MedDRA 18.1 (10040831): Skin disorder ]
Continuing Comments
Unknown
Report duplicates
Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2016012252
Parent
Parent identification Date of birth
Age
LMP date
Weight(kg) Height(cm) Sex
0
ADMINISTRATIVE AND IDENTIFICATION INFORMATION
Safetyreportversion
1
Identification of the country where the
reaction/event occur
Deutschland
Serious
No
Date Format of receipt of the most recent
information for this report
20160415
Additional documents
No
List of documents held by sender
Does this case fulfill the local criteria for an
expedited report?
No
Regulatory authority's case report number
DE-CADRBFARM-2016012252
Other case identifiers in previous
transmissions
Yes
Was the case medically confirmed, if not
initially from health professional?
No
Text for relevant medical history
and concurrent conditions
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16123733
Report Date:
15-APR-2016
Report Page:
4 of 4
Primary source(s) of information
Study name
Reporter postcode Reporter country
Qualification
98
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)
63
Height (cm)
170
>18.Lj. bis einschl. 65.Lj.
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
Dauer der Behandlung: 4 0
Sponsor study number
Study type in which the
reaction(s)/event(s)
were observed