CIOMS FORM
DE-BFARM-17015718
SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH DA MO YR
2a. AGE
66 (Year)
3. SEX
Female
4-6 REACTION ONSET DA MO YR
01
01
8-1
CHECK ALL APPROPRIATE TO ADVERSE REACTION
2017
¨ PATIENT DIED
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
nach Genuss von Lindenblütentee aus Gran Canaria Blutdruck erhöht [ MedDRA 19.1 LLT (10005750): Blood pressure increased ]
¨
INVOLVED OR PROLONGED INPATIENT HOSPITALISATION
¨
INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY
Reporter's comments: Sonstiges: die UAW sei lt. Patientin schon einmal unter der Einnahme von Lindenblütentee aufgetreten.
¨ 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?
valsartan dura 15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
"as needed" { 160 Mg milligram(s) }
¨ YES ¨ NO ¨ NA 21. DID REACTION REAPPEAR AFTER REINTRODUCTION?
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA
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)
(cont.)
pradaxa pradaxa
23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.)
(cont.)
[ MedDRA 19.1 (10028596): Myocardial infarction ] Continuing: No [ MedDRA 19.1 (10007515): Cardiac arrest ] Continuing: No
IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER
Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE 24b. MFR CONTROL NO.
DE-BFARM-17015718 24c. DATE RECEIVED BY MANUFACTURER
02-JAN-2017 DATE OF THIS REPORT
17-JAN-2017
24d. REPORT SOURCE
¨ STUDY ¨ LITERATURE þ HEALTH PROFESSIONAL 25a. REPORT TYPE
þ INITIAL ¨FOLLOW UP ¨ FINAL (Cont.) = Continuation on attached sheet(s)
Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17015718
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Reaction text as reported MedDRA coding
(... continuation ...)
Outcome* Term highlighted
Duration
17-JAN-2017 2 of 7
Time interval 1** Time interval 2*** Start date
End date
nach Genuss von Lindenblütentee aus Gran Canaria Blutdruck erhöht [MedDRA 19.1 PT (10005750): 4 Hour Blood pressure increased ]
recovered/resolved
01-JAN-2017
[ MedDRA 19.1 LLT (10005750): Blood pressure increased ] * 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
Unit
Blood pressure
120/80
mmHg
162/108
mmHg
01-JAN-2017 Blood pressure 14. Suspect Drug(s) (including generic name) Suspect Drug and batch no.
Start date
Normal high range
More inform. available
(... continuation ...)
End date
valsartan dura
Identification of the country where the drug was obtained
Duration
Dose * A: as needed B: C: 160Mg milligram(s) 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? * 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
Dose not changed
Route(s) of Administration
Indication(s)
Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17015718
17-JAN-2017 3 of 7
Active drug substance name valsartan Causality assessment Reaction
Source
Method
[ MedDRA 19.1 (10005750): Blood pressure increased ]
AkdÄ
Global Introspection (WHO GI)
14. Suspect Drug(s) (including generic name) Suspect Drug and batch no.
Start date
Result
(... continuation ...)
End date
Duration
lindenblütentee
Dose *
Route(s) of Administration
Indication(s)
A: B: C: D: E: Deutschland
Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application
Deutschland
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 lindenblueten 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.
Start date
pradaxa
End date
Duration
Dose * A: B: C: 150Mg milligram(s) D: E:
Identification of the country where the drug was obtained Name of holder/applicant
Deutschland
(... continuation ...)
Route(s) of Administration
Indication(s)
Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17015718
17-JAN-2017 4 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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name dabigatran etexilate 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.
Start date
End date
amlodipin
Duration
Dose * A: B: C: D: E:
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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval
Deutschland
(... continuation ...)
Route(s) of Administration
Indication(s)
Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17015718
17-JAN-2017 5 of 7
Active drug substance name amlodipine 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.
Start date
End date
Duration
atozet 40mg/10 mg
Dose *
(... continuation ...)
Route(s) of Administration
Indication(s)
A: B: C: D: E: Deutschland
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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name
atorvastatin calcium ezetimibe 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.
Start date
End date
pantoprazol
Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form)
Duration
Dose * A: B: C: 40Mg milligram(s) D: E:
Deutschland
(... continuation ...)
Route(s) of Administration
Indication(s)
Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17015718
17-JAN-2017 6 of 7
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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name pantoprazole 23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date End date Continuing Comments
[ MedDRA 19.1 (10028596): Myocardial infarction ]
No
Z.n. Herzinfarkt
[ MedDRA 19.1 (10007515): Cardiac arrest ]
No
Z.n. Herzstillstand
Report duplicates Duplicate source
Duplicate number
Drug Commission of the German Medical Association
DE-DCGMA-17172278
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
20170102
Additional documents
No
List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number
No
Text for relevant medical history and concurrent conditions
Drug Commission of the German Medical Association Herbert-Lewin-Platz 1 10623 Berlin, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17015718
17-JAN-2017 7 of 7
Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional?
Yes
Primary source(s) of information Study name Reporter postcode Reporter country
Qualification
74
Physician
Deutschland
Literature reference(s)
Sponsor study number
SENDER INFORMATION (... continuation ...) Type
Health professional
Organisation
Drug Commission of the German Medical Association
Department Street address
Herbert-Lewin-Platz 1
City
Berlin
Postcode
10623
Country
Deutschland
Fax
+49 / (0)30 4004 / 56555
Telephone
+49 / (0)30 4004 / 56500
E-mail address
[email protected]
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
Elderly
>65.Lj.
Study type in which the reaction(s)/event(s) were observed