CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17183830 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Blutung aus der Arteria brachialis links [ MedDRA 20.0 LLT (10071785): Arterial bleeding ] ausgeprägtes Hämatom linker Arm [ MedDRA 20.0 LLT (10018852): Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Verlauf: Hämatomausräumung Results of tests and procedures relevant to the investigation of the patient: Hb Abfall 13.3 auf 9.9 g/dl DE DA MO YR 91 DA MO YR (Year) Female 08 05 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) 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 14. SUSPECT DRUG(S) (include generic name) (cont.) xarelto 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 15 Mg milligram(s),1 Day Oral 17. INDICATION(S) FOR USE Atrial fibrillation 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 06-MAR- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10048561): Stent placement ] from 03-MAR- Continuing: [ MedDRA 20.0 (10066159): Decompensated heart failure ] from 02-MAR- Continuing: Unknown [ MedDRA 20.0 (10011099): Coronary disease ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 18-MAY- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17183830 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 5 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Blutung aus der Arteria brachialis links [MedDRA 20.0 PT (10060964): Arterial haemorrhage ] not recovered/not resolved 08-MAY- [ MedDRA 20.0 LLT (10071785): Arterial bleeding ] ausgeprägtes Hämatom linker Arm [MedDRA 20.0 PT (10018852): not recovered/not resolved 08-MAY- [ MedDRA 20.0 LLT (10018852): * 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 Normal low range Normal high range More inform. available Hemoglobin low erniedrigt/decrease d g/dl 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) xarelto 06-MAR- A: B: C: 15Mg milligram(s) D: E: 1Day Oral Atrial fibrillation 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 Dose not changed Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number
Report Page: 3 of 5 D: Number of separate dosages E: Number of units in the interval Active drug substance name rivaroxaban Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10071785): Arterial bleeding ] [ MedDRA 20.0 (10018852): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) plavix 06-MAR- A: B: C: 75Mg milligram(s) D: E: 1Day Oral Stent placement 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 Dose not changed 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 clopidogrel sulfate Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10071785): Arterial bleeding ] [ MedDRA 20.0 (10018852):
Report Page: 4 of 5 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 (10048561): Stent placement ] 03-MAR- [ MedDRA 20.0 (10066159): Decompensated heart failure ] 02-MAR- Unknown Z.n. Stent global dekompensierte Myokardinsuffizienz [ MedDRA 20.0 (10011099): Coronary disease ] [ MedDRA 20.0 (10002912): Aortic valve disease mixed ] kombiniertes Aortenvitium mit führender Stenose [ MedDRA 20.0 (10020775): Hypertension arterial ] [ MedDRA 20.0 (10012601): Diabetes mellitus ] ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 0518 No List of documents held by sender Does this case fulfill the local criteria for an expedited report? 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 Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 55 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country
Report Page: 5 of 5 Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions