CIOMS Report

CIOMS FORM
DE-BFARM-16249069
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
57
(Year)
3. SEX
Female
4-6 REACTION ONSET
DA
MO
YR
01
01
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
8-1
CHECK ALL
APPROPRIATE TO
ADVERSE REACTION
2012
(cont.)
[ MedDRA 19.0 LLT (10018276): Gingival bleeding ]
[ MedDRA 19.0 LLT (10018287): Gingival pockets ]
[ MedDRA 19.0 LLT (10018291): Gingival swelling ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
Bericht der Meldenden: "Seit der Einnahme des Blutdrucksenkendes Medikamtenes Ramipril
bemerkte ich vermehrt Zahnfleischbluten. Trotz regelmäßigen Zahnarztbesuchen, sehr korrekter
Mundhygiene und regelmäßigen professionellen Zahnreinigungen verschlechterte sich der
Zahnfleischbefund bis heute. Das Zahnfleisch weist jetzt an mehreren Stellen eine schwammige
Beschaffenheit auf, ist stark geschwollen, es haben sich sehr tiefe Taschen gebildet die trotz der
intensiven zahnmedizinischen Behandlung nicht in den Griff zu bekommen sind. Auf intensives
Nachforschen sind meine Zahnärztin und ich jetzt auf den Verdacht einer Nebenwirkung von
ramipril gekommen, denn das Beschwerdebild hat sich seit der Einnahme dieses Medikamtes
entwickelt und vor allem verschlechtert."
Sender's comment:
¨ 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?
ramipril
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
5 Mg milligram(s)
Oral
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
¨ YES ¨ NO ¨ NA
Hypertension NOS
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 01-JAN-2012
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 19.0 (10051361): Adipositas ]
(cont.)
Continuing: Yes
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-16249069
24c. DATE RECEIVED BY
MANUFACTURER
22-JUL-2016
DATE OF THIS REPORT
22-JUL-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
Report Date:
Report Page:
DE-BFARM-16249069
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
22-JUL-2016
2 of 4
(... continuation ...)
keine Begleiterkrankungen vorhanden, keine Risikofaktoren vorhanden.
Reaction text as reported
MedDRA coding
Duration
[MedDRA 19.0 PT (10018276):
Gingival bleeding ]
Outcome*
Term highlighted
Time interval 1**
Time interval 2*** Start date
Unknown
1 Day
01-JAN-2012
Unknown
1 Day
01-JAN-2012
not recovered/not
resolved
1 Day
01-JAN-2012
End date
[ MedDRA 19.0 LLT
(10018276): Gingival bleeding ]
[MedDRA 19.0 PT (10018291):
Gingival swelling ]
[ MedDRA 19.0 LLT
(10018291): Gingival swelling ]
[MedDRA 19.0 PT (10018290):
Gingival recession ]
[ MedDRA 19.0 LLT
(10018287): Gingival pockets ]
* 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
ramipril
01-JAN2012
Unit
Normal high
range
More inform.
available
(... continuation ...)
End
date
Duration
Dose *
Name of holder/applicant
Route(s) of
Administration
A:
Oral
B:
C: 5Mg milligram(s)
D:
E:
Identification of the country
where the drug was obtained
nicht spezifiziert
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
Time interval between last dose
of drug and start of reaction/event
Action(s) taken with drug
Normal low
range
Unknown
Indication(s)
Hypertension NOS
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-16249069
22-JUL-2016
3 of 4
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
ramipril
23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date End date Continuing Comments
[ MedDRA 19.0 (10051361): Adipositas ]
Yes
Report duplicates
Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2016013171
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
No
Date Format of receipt of the most recent
information for this report
20160722
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-2016013171
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
24
Consumer or other
non health
professional
Deutschland
Literature reference(s)
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-16249069
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)
105
Height (cm)
174
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
>18.Lj. bis einschl. 65.Lj.
Report Date:
Report Page:
22-JUL-2016
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