CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17188452 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR [ MedDRA 20.0 LLT (10028606): [ MedDRA 20.0 LLT (10034484): 36 DA MO YR (Year) Male 03 04 2016 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Syniptomatik: Ab dem 03.04.2016 fiel der junge Patient mit Tachykardie, Dyspnoe, erheblichem Herzstechen und febrilen Temperaturen bis maximal 39,5 C auf. Die Fokussuche ergab kein Korrelat, weitere Beschwerden beklagte der Patient nicht. Maßnahmen nach der UAW: Absetzen;Verlegung;Konsil;Diagnostik Absetzen von Clozapin; Verlegung: Innere Medizin am 08.04.2016; Internistisches Konsil und Diagnostik: Zur Fokussuche erfolgten Blutkulturen, Urinkultur, Röntgen Thorax ohne Fokus, Echokardiographie ohne sicheren Myokarditis/okarditishinweis; EKG (intern ausgewertet) 18.3. : SR, 80/min., LT, inkompl. RSB/ R/S in V4, keine ERBS; EKG vom 6.4.: SR 107/min. LT, R/S in V4 PNS, keine ERBS, das erhöhte Troponin und pro-nt-bnp wurden als Karditishinweis gewertet. II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) clozapin 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 25 Mg,1 Day 17. INDICATION(S) FOR USE DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 23-MAR-2016 to 24-MAR-2016 2 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) zyprexa from 2013 to 22-MAR-2016 zyprexa from 23-MAR-2016 to (cont.) þ þ 20. 21. INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION DID REACTION ABATE AFTER STOPPING DRUG? YES NO DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10033872): Paranoid schizophrenia ] (cont.) IV. SENDER INFORMATION 24a. ME AND ADRESS OF SENDER 30625 Hannover, DE 24c. DATE RECEIVED BY MANUFACTURER 13-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17188452 24d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIOL þ INITIAL FOLLOW UP FIL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 9 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reporter's comments: Verlauf: UAW abgeklungen Weiterbehandlung: Risperidon, später Olanzapin (Zypadhera) und Glianimon. Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT (10028606): 10 Day recovered/resolved 03-APR-2016 12-APR-2016 [ MedDRA 20.0 LLT (10028606): [MedDRA 20.0 PT (10034484): 10 Day recovered/resolved 03-APR-2016 12-APR-2016 [ MedDRA 20.0 LLT (10034484): * 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 Leucocyte count 12.3 max. Wert /nl C-reactive protein 261 max. Wert mg/l Pulse rate 121 max. Wert /min. Body temperature 39.6 max. Wert C Troponin T 0.872 max. Wert µg/l NT-proBNP 3260 max. Wert ng/l Blood culture - Urine culture - Chest X-ray - Echocardiography - 18-MAR-2016 ECG 18-MAR-2016 Sinus rhythm 80 /min 06-APR-2016 ECG 06-APR-2016 Sinus rhythm 107 /min 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 23-MAR- 24-MAR- 2 Day A:
Report Page: 3 of 9 2016 2016 C: 25Mg Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10028606): [ MedDRA 20.0 (10034484): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 25-MAR- 26-MAR- 2 Day A: 2016 2016 C: 50Mg
Report Page: 4 of 9 Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10028606): [ MedDRA 20.0 (10034484): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 26-MAR- 28-MAR- 3 Day A: 2016 2016 C: 100Mg
Report Page: 5 of 9 Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10028606): [ MedDRA 20.0 (10034484): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 29-MAR- 05-APR- 2016 2016 8 Day A: C: 150Mg Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10028606):
Report Page: 6 of 9 [ MedDRA 20.0 (10034484): 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of zyprexa 2013 22-MAR- 2016 Cululative dose number (to first reaction) C: Structure of separate dosages A: C: 25Mg olanzapine 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of zyprexa 23-MAR- 08-APR- 2016 2016 17 Day A: C: 10Mg
Report Page: 7 of 9 Cululative dose number (to first reaction) C: Structure of separate dosages olanzapine 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of risperidon 2013 24-MAR- 2016 A: C: 6Mg Cululative dose number (to first reaction) C: Structure of separate dosages risperidone 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...)
Report Page: 8 of 9 Concomitant Drug Dose * Route(s) of risperidon 25-MAR- 2016 A: C: 8Mg Cululative dose number (to first reaction) C: Structure of separate dosages risperidone 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10033872): Paranoid schizophrenia ] F20.0 Report duplicates Duplicate source der Duplicate number SLF-00-111 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Yes 20170513
Report Page: 9 of 9 Additional documents 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 Yes 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 07 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Hannover Postcode 30625 Country Fax Telephone E-mail address PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions