CIOMS Report

CIOMS FORM
DE-BFARM-16303869
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
20
(Year)
3. SEX
4-6 REACTION ONSET
Female
DA
MO
YR
31
08
2016
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
(cont.)
Druckgefühl im Bauch und Magen [ MedDRA 19.0 LLT (10070948): Upper abdominal pressure
sensation ]
[ MedDRA 19.0 LLT (10017670): Gamma GT increased ]
Lebertumor [ MedDRA 19.0 LLT (10024717): Liver tumor ]
[ MedDRA 19.0 LLT (10024676): Liver enlargement ]
Gewichtsverlust von 52 kg auf 45 kg [ MedDRA 19.0 LLT (10047900): Weight loss ]
[ MedDRA 19.0 LLT (10003028): Appetite lost ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
Bericht der Meldenden: Seit ca. 6 Monaten Gewichtsverlust von 52 auf 45 kg bemerkbar.
Blutabnahme zeigte seit über einem Monat (August 2016) hohe Leberwerte - GGT. Vor 2 Wochen
daraufhin für einen Tag stationär im Krankenhaus, da ich zusammengebrochen bin und Erbrechen
und Durchfall hatte. Diagnose "akute Lebensmittelvergiftung" - zu dem Zeitpunkt war meine jetztige
Erkrankung noch unentdeckt. Krankenhaus forderte eine Ultraschalluntersuchung des Bauchraums
bei meinem Hausarzt an. Dieser stellte am 30.08.16 eine vergrößerte Leber fest und überwies mich
am nächsten Tag zum MRT. Dort teilte mir der Arzt mit, einen 13 cm großen Tumor im Bauch
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
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
"1x täglich" [ 402 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 27-JUL-2015 to 06-SEP-2016
13 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.)
(cont.)
[ MedDRA 19.0 (10047700): Vomiting ]
Continuing: Unknown
[ MedDRA 19.0 (10012735): Diarrhoea ]
Continuing: Unknown
[ MedDRA 19.0 (10009909): Collapse circulatory ]
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-16303869
24c. DATE RECEIVED BY
MANUFACTURER
07-SEP-2016
DATE OF THIS REPORT
07-SEP-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-16303869
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Report Date:
07-SEP-2016
Report Page:
2 of 5
(... continuation ...)
entdeckt zu haben, der mit der Leber verbunden ist. Verdacht auf FNH durch Einnahme der Pille Maxim. 06.09.16 Arztbesuch
in der Uniklinik, dort wurde mir mitgeteilt, dass der vermutlich gutartige Tumor aufgrund der Größe entfernt werden muss. An
diesem Tag sofortiges Absetzen der Pille.
Results of tests and procedures relevant to the investigation of the patient:
13 cm großer Tumor im Bauch, der mit der Leber verbunden ist; V.a. fokale noduläre Hyperplasie (FNH).
Reaction text as reported
MedDRA coding
Duration
Lebertumor
[MedDRA 19.0 PT (10019695):
Hepatic neoplasm ]
Outcome*
Term highlighted
Time interval 1**
Time interval 2*** Start date
Unknown
13 Month
End date
31-AUG-2016
7 Day
[ MedDRA 19.0 LLT
(10024717): Liver tumor ]
Gewichtsverlust von 52 kg auf 45 kg
[MedDRA 19.0 PT (10047895):
Weight decreased ]
Unknown
2016
Unknown
AUG-2016
[ MedDRA 19.0 LLT
(10047900): Weight loss ]
[MedDRA 19.0 PT (10017693):
Gamma-glutamyltransferase
increased ]
[ MedDRA 19.0 LLT
(10017670): Gamma GT
increased ]
[MedDRA 19.0 PT (10019842):
Hepatomegaly ]
Unknown
13 Month
30-AUG-2016
8 Day
[ MedDRA 19.0 LLT
(10024676): Liver enlargement
]
[MedDRA 19.0 PT (10061428):
Decreased appetite ]
Unknown
[ MedDRA 19.0 LLT
(10003028): Appetite lost ]
Druckgefühl im Bauch und Magen
[MedDRA 19.0 PT (10000059):
Abdominal discomfort ]
Unknown
[ MedDRA 19.0 LLT
(10070948): Upper abdominal
pressure sensation ]
* 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
31-AUG-2016 Nuclear magnetic resonance
imaging abdominal
14. Suspect Drug(s) (including generic name)
Result
Unit
13 cm großer
Tumor im Bauch
-
Normal low
range
Normal high
range
More inform.
available
(... continuation ...)
Duration
Dose *
Route(s) of
Administration
Indication(s)
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
DE-BFARM-16303869
Suspect Drug
and batch no.
Start
date
Maxim
27-JUL- 06-SEP- 13 Month A: 1x täglich
Oral
2015
2016
B: 402Df dosage
form
C: 1Df dosage form
D: 1
E: 1Day
Report Date:
07-SEP-2016
Report Page:
3 of 5
End
date
Contraception
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
13 Month
Time interval between last dose
of drug and start of reaction/event
7 Day
Action(s) taken with drug
Drug withdrawn
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
Continuing Comments
[ MedDRA 19.0 (10047700): Vomiting ]
Unknown
[ MedDRA 19.0 (10012735): Diarrhoea ]
Unknown
[ MedDRA 19.0 (10009909): Collapse circulatory ]
Unknown
[ MedDRA 19.0 (10016958): Food poisoning, unspecified ]
Unknown
ist zusammengebrochen
Report duplicates
Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2016013582
Parent
Parent identification Date of birth
Age
0
LMP date
Weight(kg) Height(cm) Sex
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-16303869
Report Date:
07-SEP-2016
Report Page:
4 of 5
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
20160907
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-2016013582
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
76
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
[email protected]
PATIENT INFORMATION (... continuation ...)
Investigation number
Gestation period
Patient age group
Adult
Weight (kg)
45
>18.Lj. bis einschl. 65.Lj.
Sponsor study number
Study type in which the
reaction(s)/event(s)
were observed
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Height (cm)
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
Continuation sheet for CIOMS report
DE-BFARM-16303869
168
Report Date:
07-SEP-2016
Report Page:
5 of 5