CIOMS Report

CIOMS FORM
DE-BFARM-16217333
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
3. SEX
4-6 REACTION ONSET
DA
MO
YR
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
(cont.)
8-1
CHECK ALL
APPROPRIATE TO
ADVERSE REACTION
¨ PATIENT DIED
[ MedDRA 19.0 LLT (10054209): Gastrointestinal discomfort ]
INVOLVED OR
Kniegelenkschmerzen [ MedDRA 19.0 LLT (10023477): Knee pain ]
PROLONGED
[ MedDRA 19.0 LLT (10042174): Strength loss of ]
INPATIENT
Stechende Schmerzen auf dem Rückenbereich [ MedDRA 19.0 LLT (10003978): Back ache ]
HOSPITALISATION
[ MedDRA 19.0 LLT (10005034): Bladder discomfort ]
INVOLVED
Blasen an den Armen [ MedDRA 19.0 LLT (10005216): Blisters ]
[ MedDRA 19.0 LLT (10009197): Circulatory instability ]
PERSISTENCE OR
[ MedDRA 19.0 LLT (10076336): Rigours ]
SIGNIFICANT
[ MedDRA 19.0 LLT (10010300): Confusion ]
DISABILITY OR
[ MedDRA 19.0 LLT (10024491): Light-headed feeling ]
INCAPACITY
[ MedDRA 19.0 LLT (10006332): Breath shortness ]
LIFE THREATENING
Rötung und Stechen der Arme,Körper bis zu den Lenden [ MedDRA 19.0 LLT (10038198):
Redness ]
CONGENITAL
Schmerzen am Schultergürtel [ MedDRA 19.0 LLT (10040617): Shoulder pain ]
ANOMALY / BIRTH
[ MedDRA 19.0 LLT (10065061): Stinging skin ]
DEFECT
bräunliche Rötung am Schienbein [ MedDRA 19.0 LLT (10040829): Skin discolouration ]
[ MedDRA 19.0 LLT (10034218): Peeling ]
OTHER MEDICALLY
[ MedDRA 19.0 LLT (10041232): Sneezing ]
IMPORTANT
[ MedDRA 19.0 LLT (10047543): Visual disturbance ]
CONDITION
Brennen der Haut am Hals [ MedDRA 19.0 LLT (10006792): Burning skin ]
II. SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG(S) (include generic name)
(cont.) 20. DID REACTION ABATE
AFTER STOPPING DRUG?
omniscan
¨
¨
¨
¨
þ
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
¨ YES ¨ NO ¨ NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA
Nuclear magnetic resonance imaging
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 12-APR-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 19.0 (10029815): Nuclear magnetic resonance imaging ]
from 12-APR-2016
(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-16217333
24c. DATE RECEIVED BY
MANUFACTURER
16-JUN-2016
DATE OF THIS REPORT
28-JUN-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-16217333
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Report Date:
Report Page:
28-JUN-2016
2 of 6
(... continuation ...)
[ MedDRA 19.0 LLT (10060800): Hot flush ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant information:
Maßnahmen/Therapie:
Prednisolon und Antiallergiemittel
Nach drei-wöchiger Behandlung mit Prednisolon war die Haut immer noch gerötet, das Brennen hatte nachgelassen
Reaction text as reported
MedDRA coding
Duration
Outcome*
Term highlighted
Time interval 1**
Time interval 2*** Start date
Unknown
2 Hour
Unknown
2 Hour
recovered/resolved
2 Hour
Stechende Schmerzen auf dem Rückenbereich
[MedDRA 19.0 PT (10003988):
Back pain ]
[ MedDRA 19.0 LLT
(10003978): Back ache ]
Schmerzen am Schultergürtel
[MedDRA 19.0 PT (10028391):
Musculoskeletal pain ]
[ MedDRA 19.0 LLT
(10040617): Shoulder pain ]
Brennen der Haut am Hals
[MedDRA 19.0 PT (10054786):
Skin burning sensation ]
[ MedDRA 19.0 LLT
(10006792): Burning skin ]
Rötung und Stechen der Arme,Körper bis zu den Lenden
[MedDRA 19.0 PT (10015150):
Erythema ]
not recovered/not
resolved
[ MedDRA 19.0 LLT
(10038198): Redness ]
[MedDRA 19.0 PT (10060800):
Hot flush ]
Unknown
[ MedDRA 19.0 LLT
(10060800): Hot flush ]
[MedDRA 19.0 PT (10008531):
Chills ]
Unknown
[ MedDRA 19.0 LLT
(10076336): Rigours ]
[MedDRA 19.0 PT (10033474):
Pain of skin ]
Unknown
[ MedDRA 19.0 LLT
(10065061): Stinging skin ]
Blasen an den Armen
[MedDRA 19.0 PT (10005191):
Blister ]
[ MedDRA 19.0 LLT
(10005216): Blisters ]
Unknown
2 Week
End date
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
[MedDRA 19.0 PT (10040844):
Skin exfoliation ]
Continuation sheet for CIOMS report
DE-BFARM-16217333
Unknown
[ MedDRA 19.0 LLT
(10034218): Peeling ]
bräunliche Rötung am Schienbein
[MedDRA 19.0 PT (10040829):
Skin discolouration ]
Unknown
[ MedDRA 19.0 LLT
(10040829): Skin discolouration
]
[MedDRA 19.0 PT (10007649):
Cardiovascular disorder ]
Unknown
[ MedDRA 19.0 LLT
(10009197): Circulatory
instability ]
[MedDRA 19.0 PT (10013968):
Dyspnoea ]
Unknown
[ MedDRA 19.0 LLT
(10006332): Breath shortness ]
[MedDRA 19.0 PT (10047571):
Visual impairment ]
Unknown
[ MedDRA 19.0 LLT
(10047543): Visual disturbance
]
[MedDRA 19.0 PT (10013573):
Dizziness ]
Unknown
[ MedDRA 19.0 LLT
(10024491): Light-headed
feeling ]
[MedDRA 19.0 PT (10010305):
Confusional state ]
Unknown
[ MedDRA 19.0 LLT
(10010300): Confusion ]
[MedDRA 19.0 PT (10003549):
Asthenia ]
Unknown
[ MedDRA 19.0 LLT
(10042174): Strength loss of ]
[MedDRA 19.0 PT (10041232):
Sneezing ]
Unknown
[ MedDRA 19.0 LLT
(10041232): Sneezing ]
Kniegelenkschmerzen
[MedDRA 19.0 PT (10003239):
Arthralgia ]
Unknown
[ MedDRA 19.0 LLT
(10023477): Knee pain ]
[MedDRA 19.0 PT (10005034):
Bladder discomfort ]
Unknown
2 Week
Report Date:
Report Page:
28-JUN-2016
3 of 6
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-16217333
28-JUN-2016
4 of 6
[ MedDRA 19.0 LLT
(10005034): Bladder discomfort
]
[MedDRA 19.0 PT (10000059):
Abdominal discomfort ]
Unknown
[ MedDRA 19.0 LLT
(10054209): Gastrointestinal
discomfort ]
* 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
omniscan
12-APR2016
Unit
Identification of the country
where the drug was obtained
Duration
Dose *
A:
B:
C:
D:
E:
Deutschland
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
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?
Active drug substance name
gadodiamide
Normal high
range
More inform.
available
(... continuation ...)
End
date
* 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
Normal low
range
Deutschland
Route(s) of
Administration
Indication(s)
Nuclear magnetic
resonance imaging
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
23. Other relevant history
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-16217333
28-JUN-2016
5 of 6
(... continuation ...)
Reactions, Symptoms and Events
Start date End date Continuing Comments
[ MedDRA 19.0 (10029815): Nuclear magnetic resonance
imaging ]
12-APR2016
Unknown
MRT Herz
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
20160616
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
Other case identifiers in previous
transmissions
Was the case medically confirmed, if not
initially from health professional?
No
Primary source(s) of information
Study name
Reporter postcode Reporter country
Qualification
01
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
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
PATIENT INFORMATION (... continuation ...)
Investigation number
Gestation period
Patient age group
Weight (kg)
Height (cm)
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
DE-BFARM-16217333
Report Date:
Report Page:
28-JUN-2016
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