CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17188381 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 [ MedDRA 20.0 LLT (10013911): innerlich unruhig [ MedDRA 20.0 LLT (10043266): Tense ] [ MedDRA 20.0 LLT (10023151): Jaw joint rigid state of ] 33 DA MO YR (Year) Female 25 12 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Symptomatik: Unter der Behandlung mit Elontril trat (nach Dosiserhöhung von 150 auf 300 mg) eine Geschmacksveränderung auf. Es habe alles nur noch süßlich geschmeckt, des Weiteren habe die Patientin sich sehr starr in der Kieferregion gefühlt und war zeitgleich innerlich unruhig. Lebensbedrohlich: nein, schwer nach GCP: ja, weil medizinisch bedeutsam Begründung des Wahrscheinlichkeitsgrads: Der Zusammenhang mit der Elontril- Medikation erscheint am wahrscheinlichsten, da die Nebenwirkungen unter der Medikation beschrieben sind, die Geschmacksveränderungen sind unter den häufigen Nebenwirkungen beschrieben. Da die Symptome unter der Dosisreduktion sistierten, halten wir die medikamentös-bedingte Genese für am wahrscheinlichsten. Ein Zusammenhang mit 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) 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.) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 150 Mg,1 Day 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 16-DEC- to 22-DEC- 7 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) valdoxan from 28-DEC- 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10012399): Depressive disorder ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 13-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17188381 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 6 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) dem Valdoxan ist weniger wahrscheinlich, da die UAW nicht unter der Medikation beschrieben ist und Valdoxan unverändert weitergegeben wurde. Die Symptomatik sistierte sofort nach Reduktion der Medikation. Weiterbehandlung: Reduktion von Elontril von 300 mg auf 15O mg Mögliche Risikofaktoren: nein Alternativerklärungen: nein Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT (10013911): 19 Day recovered/resolved 25-DEC- 12-JAN-2017 [ MedDRA 20.0 LLT (10013911): innerlich unruhig [MedDRA 20.0 PT (10043268): Tension ] 19 Day recovered/resolved 25-DEC- 12-JAN-2017 [ MedDRA 20.0 LLT (10043266): Tense ] [MedDRA 20.0 PT (10023230): Joint stiffness ] 19 Day recovered/resolved 25-DEC- 12-JAN-2017 [ MedDRA 20.0 LLT (10023151): Jaw joint rigid state of ] * 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 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of 16-DEC- 22-DEC- 7 Day A: C: 150Mg 10 Day
Report Page: 3 of 6 4 Day Dose increased Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages bupropion hydrochloride Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10013911): AMSP Global Introspection (WHO GI) probable/likely 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of 23-DEC- 10-JAN- 2017 19 Day A: C: 300Mg 3 Day 17 Day Dose reduced Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages bupropion hydrochloride Causality assessment
Report Page: 4 of 6 Reaction Source Method Result [ MedDRA 20.0 (10013911): AMSP Global Introspection (WHO GI) probable/likely 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of 11-JAN- 2017 A: C: 150Mg 18 Day Dose not changed Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages bupropion hydrochloride Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10013911): AMSP Global Introspection (WHO GI) probable/likely 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of valdoxan 28-DEC- A: C: 25Mg
Report Page: 5 of 6 Dose not changed Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages agomelatine 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10012399): Depressive disorder ] Unknown Rezidivierende depressive Störung, gegenwärtig schwere Episode ohne psychotische Symptome Report duplicates Duplicate source AMSP - Institut für Arzneimittelsicherheit in der Duplicate number HOV-14-005 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 20170513 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
Report Page: 6 of 6 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 30 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 Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions