CIOMS FORM
DE-BFARM-17053675
SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH DA MO YR
2a. AGE
61 (Year)
3. SEX
4-6 REACTION ONSET DA MO YR
Female
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
8-1
2010 (cont.)
CHECK ALL APPROPRIATE TO ADVERSE REACTION
¨ PATIENT DIED
Todesangst [ MedDRA 19.1 LLT (10002855): Anxiety ] INVOLVED OR wandernde massive Gelenkschmerzen in Ellbogen, Fingern, Knien Fußgelenken [ MedDRA 19.1 PROLONGED LLT (10023222): Joint pain ] INPATIENT Dauerhafter extremer Schmerz in den Großzehengrundgelenken [ MedDRA 19.1 LLT (10033452): HOSPITALISATION Pain in toe ] INVOLVED reißende Schmerzen in den Achillessehnen [ MedDRA 19.1 LLT (10050471): Achilles tendon pain ] PERSISTENCE OR [ MedDRA 19.1 LLT (10061218): Inflammation ] SIGNIFICANT Instabilität des Fußbandapparates mit Neigung zu Bänderrissen [ MedDRA 19.1 LLT (10074599): DISABILITY OR Tendon discomfort ] INCAPACITY Instabilität des Fußbandapparates mit Neigung zu Brüchen [ MedDRA 19.1 LLT (10061728): LIFE THREATENING Bone lesion ] [ MedDRA 19.1 LLT (10012378): Depression ] CONGENITAL [ MedDRA 19.1 LLT (10016257): Fatigue extreme ] ANOMALY / BIRTH [ MedDRA 19.1 LLT (10072623): Avolition ] DEFECT [ MedDRA 19.1 LLT (10024461): Light headedness ] [ MedDRA 19.1 LLT (10004070): Balance difficulty ] OTHER MEDICALLY [ MedDRA 19.1 LLT (10027172): Memory disturbance ] IMPORTANT [ MedDRA 19.1 LLT (10010250): Concentration impairment ] CONDITION [ MedDRA 19.1 LLT (10029328): Neuropathy ] II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) 20. DID REACTION ABATE AFTER STOPPING DRUG? ciprobay
¨
þ ¨ ¨
¨
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
Oral 17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA 21. DID REACTION REAPPEAR AFTER REINTRODUCTION?
¨ YES ¨ NO ¨ NA
Urinary tract infection 18. THERAPY DATES (from/to)
19. THERAPY DURATION
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.)
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-17053675 24c. DATE RECEIVED BY MANUFACTURER
15-FEB-2017 DATE OF THIS REPORT
20-FEB-2017
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-17053675
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Report Date: Report Page:
20-FEB-2017 2 of 7
(... continuation ...)
Berührungsempfindlichkeit [ MedDRA 19.1 LLT (10000184): Abnormal touch sensation ] [ MedDRA 19.1 LLT (10028347): Muscle twitching ] Steifigkeit insbesondere der Füße und Finger [ MedDRA 19.1 LLT (10024509): Limbs stiffness ] Blasenschwäche [ MedDRA 19.1 LLT (10021643): Incontinence urinary ] Nierenschwäche [ MedDRA 19.1 LLT (10062237): Renal impairment ] [ MedDRA 19.1 LLT (10023432): Kidney pain ] [ MedDRA 19.1 LLT (10008531): Chills ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Direkt nach Einnahme von Levofloxacin: Schüttelfrost, Todesangst. Zeitversetzt nach Ciprofloxacin:wandernde massive Gelenkschmerzen in Ellbogen, Fingern, Knien Fußgelenken. Dauerhafter extremer Schmerz in den Großzehengrundgelenken,reißende Schmerzen in den Achillessehnen,Übergang zum Außenband mit Entzündungen. Instabilität des Fußbandapparates mit Neigung zu Brüchen und Bänderrissen. Depressionen und extreme Müdigkeit, Antriebslosigkeit, Schwindel, Gleichgewichtsstörungen, Gedächtnis- und Konzentrationsschwierigkeiten, Neuropathien/ Berührungsempfindlichkeit, Muskelzuckungen, Steifigkeit, insbesondere der Füße und Finger. Nieren- und Blasenschwäche, Nierenschmerzen. Alles in wechselhafter Intensität, jedoch dauerhaft vorhanden. Sender's comment: Keine Risikofaktoren,vor Gabe dieser Mittel kerngesund
Reaction text as reported MedDRA coding
Duration
[MedDRA 19.1 PT (10008531): 7 Year Chills ]
Outcome* Term highlighted
Time interval 1** Time interval 2*** Start date
End date
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
[ MedDRA 19.1 LLT (10008531): Chills ] Todesangst [MedDRA 19.1 PT (10002855): 7 Year Anxiety ] [ MedDRA 19.1 LLT (10002855): Anxiety ] wandernde massive Gelenkschmerzen in Ellbogen, Fingern, Knien Fußgelenken [MedDRA 19.1 PT (10003239): 7 Year Arthralgia ]
recovered/resolved with sequel
2010
[ MedDRA 19.1 LLT (10023222): Joint pain ] Dauerhafter extremer Schmerz in den Großzehengrundgelenken [MedDRA 19.1 PT (10033425): 7 Year Pain in extremity ]
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with
2010
[ MedDRA 19.1 LLT (10033452): Pain in toe ] reißende Schmerzen in den Achillessehnen [MedDRA 19.1 PT (10066371): 7 Year Tendon pain ] [ MedDRA 19.1 LLT (10050471): Achilles tendon pain ] [MedDRA 19.1 PT (10061218): 7 Year
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Inflammation ]
Continuation sheet for CIOMS report DE-BFARM-17053675
Report Date: Report Page:
sequel
[ MedDRA 19.1 LLT (10061218): Inflammation ] Instabilität des Fußbandapparates mit Neigung zu Bänderrissen [MedDRA 19.1 PT (10074599): 7 Year Tendon discomfort ]
recovered/resolved with sequel
2010
[ MedDRA 19.1 LLT (10074599): Tendon discomfort ] Instabilität des Fußbandapparates mit Neigung zu Brüchen [MedDRA 19.1 PT (10061728): 7 Year Bone lesion ]
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
[ MedDRA 19.1 LLT (10061728): Bone lesion ] [MedDRA 19.1 PT (10012378): 7 Year Depression ] [ MedDRA 19.1 LLT (10012378): Depression ] [MedDRA 19.1 PT (10016256): 7 Year Fatigue ] [ MedDRA 19.1 LLT (10016257): Fatigue extreme ] [MedDRA 19.1 PT (10002942): 7 Year Apathy ] [ MedDRA 19.1 LLT (10072623): Avolition ] [MedDRA 19.1 PT (10013573): 7 Year Dizziness ] [ MedDRA 19.1 LLT (10024461): Light headedness ] [MedDRA 19.1 PT (10049848): 7 Year Balance disorder ] [ MedDRA 19.1 LLT (10004070): Balance difficulty ] [MedDRA 19.1 PT (10027175): 7 Year Memory impairment ] [ MedDRA 19.1 LLT (10027172): Memory disturbance ] [MedDRA 19.1 PT (10013496): 7 Year Disturbance in attention ] [ MedDRA 19.1 LLT (10010250): Concentration impairment ] [MedDRA 19.1 PT (10029331): 7 Year Neuropathy peripheral ] [ MedDRA 19.1 LLT (10029328): Neuropathy ]
20-FEB-2017 3 of 7
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17053675
20-FEB-2017 4 of 7
Berührungsempfindlichkeit [MedDRA 19.1 PT (10033775): 7 Year Paraesthesia ]
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
recovered/resolved with sequel
2010
[ MedDRA 19.1 LLT (10000184): Abnormal touch sensation ] [MedDRA 19.1 PT (10028347): 7 Year Muscle twitching ] [ MedDRA 19.1 LLT (10028347): Muscle twitching ] Steifigkeit insbesondere der Füße und Finger [MedDRA 19.1 PT (10052904): 7 Year Musculoskeletal stiffness ] [ MedDRA 19.1 LLT (10024509): Limbs stiffness ] Blasenschwäche [MedDRA 19.1 PT (10046543): 7 Year Urinary incontinence ] [ MedDRA 19.1 LLT (10021643): Incontinence urinary ] Nierenschwäche [MedDRA 19.1 PT (10062237): 7 Year Renal impairment ] [ MedDRA 19.1 LLT (10062237): Renal impairment ] [MedDRA 19.1 PT (10038490): 7 Year Renal pain ] [ MedDRA 19.1 LLT (10023432): Kidney pain ] * 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
ciprobay
Identification of the country where the drug was obtained Name of holder/applicant
End date
Unit
Normal low range
Normal high range
More inform. available
(... continuation ...) Duration
Dose *
Route(s) of Administration
Indication(s)
A: B: C: D: E:
Oral
Urinary tract infection
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17053675
20-FEB-2017 5 of 7
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? * 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 ciprofloxacin hydrochloride 14. Suspect Drug(s) (including generic name) Suspect Drug and batch no.
Start date
(... continuation ...)
End date
levofloxacin
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 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
Duration
Dose *
Route(s) of Administration
Indication(s)
A: B: C: D: E:
Oral
Urinary tract infection
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17053675
20-FEB-2017 6 of 7
Active drug substance name levofloxacin Report duplicates Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2017015596
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
Yes
Date Format of receipt of the most recent information for this report
20170215
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-2017015596
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
65
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
Sponsor study number
Study type in which the reaction(s)/event(s) were observed
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Country
Continuation sheet for CIOMS report DE-BFARM-17053675 Deutschland
Fax Telephone E-mail address
[email protected]
PATIENT INFORMATION (... continuation ...) Investigation number Gestation period Patient age group
Adult
Weight (kg)
65
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:
20-FEB-2017 7 of 7