CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17152663 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10002948): Aphasia ] linkshemisph. Ischämie (10008120): Cerebral ischaemia ] (10013950): Dysphagia ] (10019470): Hemiplegia (right) ] (10057219): Ocular deviation ] Reporter's comments: DE DA MO YR 83 DA MO YR (Year) Male 11 04 2017 Maßnahme: Monitoring/Stroke, Umstellung auf Apixaban. Keine akute HKU notwendig. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED þ 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 17. INDICATION(S) FOR USE Atrial fibrillation 18. THERAPY DATES (from/to) 19. THERAPY DURATION 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) circadin daily dose: 2 Mg millgram(s) every Days circadin daily dose: 2 Mg millgram(s) every Days (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10020823): Hypertensive heart disease ] Continuing: Unknown [ MedDRA 20.0 (10020775): Hypertension arterial ] Continuing: Unknown [ MedDRA 20.0 (10020775): Hypertension arterial ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 24-APR-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17152663 24d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 7 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT (10002948): Aphasia ] (10002948): Aphasia ] linkshemisph. Ischämie [MedDRA 20.0 PT (10008120): Cerebral ischaemia ] (10008120): Cerebral ischaemia ] [MedDRA 20.0 PT (10013950): Dysphagia ] (10013950): Dysphagia ] [MedDRA 20.0 PT (10019468): Hemiplegia ] (10019470): Hemiplegia (right) ] [MedDRA 20.0 PT (10061129): Eye movement disorder ] (10057219): Ocular deviation ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** and start of reaction/event Results of tests Date Test Result Unit Normal low range Normal high range More inform. available Troponin T erhöht/increased NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of xarelto A: C: D: E: Atrial fibrillation
Report Page: 3 of 7 Cumulative dose number (to first reaction) C: Structure dosages number rivaroxaban Causality assessment Reaction Source Method Result AkdÄ Global Introspection (WHO GI) 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of circadin A: daily dose: 2 Mg millgram(s) every Days C: 2Mg milligram(s) D: 1 E: 1Day
Report Page: 4 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages melatonin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of pantoprazol A: daily dose: 40 Mg millgram(s) every Days C: 40Mg milligram(s) D: 1 E: 1Day Cululative dose number (to first reaction) C: Structure of separate dosages pantoprazole 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of ramipril A: daily dose: 10 Mg millgram(s) every Days C: 10Mg milligram(s) D: 1 E: 1Day
Report Page: 5 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages ramipril 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10020823): Hypertensive heart disease ] Unknown dekompensierte hypertensive Herzkrankheit [ MedDRA 20.0 (10020775): Hypertension arterial ] Unknown [ MedDRA 20.0 (10020775): Hypertension arterial ] Unknown [ MedDRA 20.0 (10042244): Stroke ] 2012 Unknown [ MedDRA 20.0 (10076919): Small bowel infarction ] 2016 Unknown [ MedDRA 20.0 (10049203): Bradycardia-tachycardia syndrome ] [ MedDRA 20.0 (10007598): Cardiac pacemaker insertion ] 04-MAY- 2015 Unknown Unknown Report duplicates Duplicate source Duplicate number DE-DCGMA-17173467 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0
Report Page: 6 of 7 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents Yes 20170424 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? Yes 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 52 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode 10623 Country Fax +49 / (0)30 4004 / 56555 Telephone +49 / (0)30 4004 / 56500 E-mail address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) Height (cm)
Report Page: 7 of 7 Last menstrual periode Text for relevant medical history and concurrent conditions