CIOMS FORM

DE-BFARM-16113389

SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS

1a. COUNTRY

DE

privacy

2. DATE OF BIRTH DA

MO

2a. AGE

3. SEX

YR

4-6 REACTION ONSET DA

MO

YR

Male

7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)

(cont.)

flacher werdende Atmung, beim Ausatmen musste die Luft ausgeblasen werden [ MedDRA 18.1 LLT (10038683): Respiratory disorder ] unerklärbares Herzunwohlsein, leichte Stiche, Heiß- oder Kaltgefühl, Herzbereich immer spürbar, unangenehmes Gefühl [ MedDRA 18.1 LLT (10054211): Cardiac discomfort ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Nach der Einnahme von Eliquis 5mg wegen erstmaligem Vorhofflimmern habe ich bisher nicht protokollierte Nebenwirkungen festgestellt: 1. Unerklärbares "Herzunwohlsein" - leichte Stiche, Heiß- oder Kaltgefühl, Herzbereich immer irgendwie spürbar, unangemehmes Gefühl aber zunächst keine körperliche Beeinträchtigung (später siehe 2). Keine Veränderung bei (leichterer) körperlicher Tätigkeit - Gedanken an Infarkt bzw. Nebenwirkung "Blutung im Herzbeutel" - keine Angstzustände 2. Irgendwann während der Einnahmezeit (nach 8-10 Tagen ?) flacher werdende Atmung (sah ich nicht im Zusammenhang mit Eliquis), beim Ausatmen habe ich häufiger die Luft ausblasen müssen, was mehr oder weniger "automatisch" geschah. So, als ob die "vegetative Atmungssteuerung" nicht

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

¨

OTHER MEDICALLY IMPORTANT CONDITION

II. SUSPECT DRUG(S) INFORMATION (cont.) 20. DID REACTION ABATE

14. SUSPECT DRUG(S) (include generic name)

AFTER STOPPING DRUG?

eliquis 5mg 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

Atrial fibrillation 18. THERAPY DATES (from/to)

19. THERAPY DURATION

from 18-JAN-2016 to 29-JAN-2016

12 Day 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 18.1 (10074862): Mitral valve insufficiency ] Continuing: Unknown [ MedDRA 18.1 (10035664): Pneumonia ] from 1945 Continuing: Unknown [ MedDRA 18.1 (10019277): Heart disorder ] from 1952 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-16113389 24c. DATE RECEIVED BY MANUFACTURER

01-APR-2016 DATE OF THIS REPORT

07-APR-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-16113389

7. + 13. Describe Reaction(s) (including relevant tests/lab data)

Report Date:

07-APR-2016

Report Page:

2 of 5

(... continuation ...)

funktionierte. Einnahmezeitraum: 18.01. bis 29.01.16 5 mg, ab 30.01.16: 2,5 mg wegen blutender Hautausschläge auf beiden Handrücken, Nebenwirkungen von Digimerck und Belok Zok. Ab 13/14.02.16 Zustand nach 1. Ab 18.02.16 abends Eliquis (2.5 mg) abgesetzt, nach da 12 h abklingende Beschwerden gem. 1. Zustand nach 2. blieb noch ca. 6-8 Tage - abflauend. Herzzustand: altersbezogen gut bis sehr gut, starke Herzmuskel (Leistungssport in Schulzeit und Jugend, Radtouren 150-200km/Tag). Aber: "leichte Mitralklappeninsuffizienz" (mit Prolaps des PZ). Ursache: Wohl starke Unterkühlung mit doppelseitiger Lungenentzündung Januar/Februar 1945. "Herzpkappern" im Schulkindalter (ca 1952/53) festgestellt - keine Diagnose möglich. Reaction text as reported MedDRA coding

Outcome* Term highlighted

Duration

Time interval 1** Time interval 2*** Start date

End date

unerklärbares Herzunwohlsein, leichte Stiche, Heiß- oder Kaltgefühl, Herzbereich immer spürbar, unangenehmes Gefühl [MedDRA 18.1 PT (10054211): recovering/resolving Cardiac discomfort ] [ MedDRA 18.1 LLT (10054211): Cardiac discomfort ] flacher werdende Atmung, beim Ausatmen musste die Luft ausgeblasen werden [MedDRA 18.1 PT (10038683): recovering/resolving Respiratory disorder ] [ MedDRA 18.1 LLT (10038683): Respiratory disorder ] * 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)

Unit

Normal low range

Normal high range

More inform. available

(... continuation ...)

Suspect Drug and batch no.

Start date

End date

eliquis 5mg

18-JAN- 29-JAN- 12 Day 2016 2016

Identification of the country where the drug was obtained

Duration

Dose *

A: Oral B: C: 5Mg 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

Route(s) of Administration

Deutschland

Indication(s) Atrial fibrillation

BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE

Continuation sheet for CIOMS report DE-BFARM-16113389

Report Date:

07-APR-2016

Report Page:

3 of 5

Time interval between last dose of drug and start of reaction/event Dose reduced

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 apixaban 14. Suspect Drug(s) (including generic name)

(... continuation ...)

Suspect Drug and batch no.

Start date

End date

eliquis 2.5mg

30-JAN- 18-FEB- 20 Day 2016 2016

Identification of the country where the drug was obtained

Duration

Dose *

Route(s) of Administration

A: B: C: 2.5Mg milligram(s) D: E:

Oral

Indication(s)

Deutschland

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

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 apixaban 23. Other relevant history

(... continuation ...)

Reactions, Symptoms and Events

Start date End date

[ MedDRA 18.1 (10074862): Mitral valve insufficiency ] [ MedDRA 18.1 (10035664): Pneumonia ]

Continuing Comments Unknown

1945

Unknown

BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE

Continuation sheet for CIOMS report DE-BFARM-16113389

[ MedDRA 18.1 (10019277): Heart disorder ]

1952

Unknown

Report Date:

07-APR-2016

Report Page:

4 of 5

im Schulkindalter (ca. 1952/53) festgestelltes "Herzklappern" - keine Diagnose möglich.

Patient past drug therapy Name of drug as reported

Indication MedDRA code

Reactions MedDRA code

digimerck

[ MedDRA 18.1 (0): unbekannt ]

[ MedDRA 18.1 (10058677): Skin bleeding ]

beloc-zok

[ MedDRA 18.1 (0): unbekannt ]

[ MedDRA 18.1 (10058677): Skin bleeding ]

Start date End date

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

20160401

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 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

40

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

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-16113389

Telephone 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

Report Date:

07-APR-2016

Report Page:

5 of 5