CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17208046 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 82 (Year) massiver Haarausfall [ MedDRA 20.0 LLT (10019045): Hair loss ] Female DA MO YR Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Massiver Haarausfall unter den Medikamenten Metohexal, Candesartan und Elquis. Patientin ist weiblich, 82 Jahre alt. Sie wiegt bei 170 cm 55 kg. Sie ist vital, aktiv: Haushalt, Garten, Reisen, mobil (Autofahren auch weite Strecken), diszipliniert, treibt Gymnastik, ist geistig klar und interessiert: Lesen, Theater, Konzerte, Obernabo, iphone und ipad. Anamnese: kein Diabetes, keine Hypertonie, keine Allergie, keine Laktose-Allergie. Vor 8 Jahren brusterhaltende Operation eines Mamma-Carcinoms rechts, 1,2 cm Sentinel Lk hist frei. Anschließend Röntenbestrahlung und über 5 Jahre Anastrozol ab 15.08.2010. Unter dieser Medikation vorübergehender starker Haarausfall, mit Therapieende sistiert. Vor 10 Jahren Katheter-Ablatation eines atypischen Impulsgeberknotens mit Tachyarrhythmie linke Herzkammer, septumnah. Unter Multaq400 + Blopres + ASS 100 unnd Metohexal gut eingestellt. 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) 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.) metohexal 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 47.5 Mg milligram(s) 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 07-FEB-2008 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 (10006187): Breast cancer ] from 1999 Continuing: Unknown [ MedDRA 20.0 (10006187): Breast cancer ] from 1999 Continuing: Unknown [ MedDRA 20.0 (10037770): Radiation therapy ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 12-JUN-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17208046 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 8 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Seit e 2014 und im Jahresverlauf rezidivierendes Vorhofflimmern, mehrfache Elektrocardioversionen. Dezember Kath. Pulmonalvenen Isolation PVI. Bisher unter obiger Medikation kein erneutes Vorhofflimmern, leistungsfähig. EKG Kontrollen ohne gravierende Extrasystolie.Blutstatuskontrollen: o.b., Nieren- und Leberwerte normal. Results of tests and procedures relevant to the investigation of the patient: EKG Kontrollen ohne gravierende Extrasystolie Blutstatuskontrollen: o.b., Nieren- und Leberwerte normal. Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** massiver Haarausfall [MedDRA 20.0 PT (10001760): Alopecia ] Unknown [ MedDRA 20.0 LLT (10019045): Hair loss ] * 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 metohexal 07-FEB- 2008 A: C: 47.5Mg milligram(s)
Report Page: 3 of 8 Cumulative dose number (to first reaction) metoprolol tartrate metohexal 06-APR- 2009 Cumulative dose number (to first reaction) A: C: 95Mg milligram(s) metoprolol tartrate metohexal 07-FEB- 2010 A: C: 23.75Mg milligram(s)
Report Page: 4 of 8 Dose not changed Cumulative dose number (to first reaction) metoprolol tartrate candesartan 2014 A: C: fortlaufende Medikation Cumulative dose number (to first reaction) candesartan
Report Page: 5 of 8 eliquis JAN- DEC- 11 Month A: daily dose: 10 Mg milligram(s) every Day C: 5Mg milligram(s) 2 1Day Cumulative dose number (to first reaction) apixaban apixaban JAN- 2016 A: C:
Report Page: 6 of 8 Cumulative dose number (to first reaction) apixaban eliquis JAN- 2016 A: daily dose: 5 Mg milligram(s) every Day C: 2.5Mg milligram(s) 2 1Day Cumulative dose number (to first reaction) apixaban 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments
Report Page: 7 of 8 [ MedDRA 20.0 (10006187): Breast cancer ] 1999 Unknown Brusterhaltende Operation wegen Mamma-Carcinom rechts 1.2 cm Sentinel Lk hist frei. [ MedDRA 20.0 (10037770): Radiation therapy ] Unknown [ MedDRA 20.0 (10049447): Tachyarrhythmia ] Tachyarrhytmie linke Herzkammer [ MedDRA 20.0 (10003658): Atrial fibrillation ] DEC- 2014 Unknown [ MedDRA 20.0 (10007661): Cardioversion ] Unknown mehrfache Elektrocardioversionen [ MedDRA 20.0 (10072901): Pulmonary vein isolation ] DEC- Kath. Pulmonalvenen Isolation [ MedDRA 20.0 (10059864): Cardiac ablation ] 2007 Unknown Katheterablatation eines atyp. Impulsgeberknotens mit Tachyarrhythmie linke Herzkammer Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code anastrozole [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (10019045): Hair loss ] 15-AUG- 2010 multaq 400 [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (0): unbekannt ] 04-FEB- 2010 05-AUG- blopress 8 mg/12.5mg [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (0): unbekannt ] 2010 2012 ass 100 [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (0): unbekannt ] APR- 2009 2014 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 No 20170612 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
Report Page: 8 of 8 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 74 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 55 Height (cm) 170 Last menstrual periode Text for relevant medical history and concurrent conditions Kein Diabetes, keine Hypertonie, keine Allergie, keine Lactose-Allergie. Patientin ist schlank, vital, aktiv: Haushalt, Garten, Reisen, mobil (Autofahren auch lange Strecken), diszipliniert, Gymnastik uw. geistig klar und interessiert: Lesen, Theater, Konzerte, Obernabo, iphone und ipad.