SUSPECT ADVERSE REACTION REPORT

Transcription

1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM 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 ( ): 76 DA MO YR (Year) Female Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Symptomatik: Suizid durch Erhängen; Medikation Sertralin und Mirtazapin soziale Ananmnese: verwitwet; finanzielle Situation: Rente; Suizidanamnese: bisher keine Suizidalität; Suizid am ; Ort: Zuhause (Keller); ernsthafte Suizidhandlung; unauffälliges Verhalten gegenüber der Tochter am Abend, am nächsten Morgen suizidiert aufgefunden. Frühere Exposition: ja, negativ (keine solche UAW); keine UAW angegeben seit Beginn der Medikation Sertralin 6/15; Mirtazapin 8/15 Alternativerklärungen: ja - eher wahrscheinlich; mangelnde Akzeptanz der Lebensumstände, Gefühl von Einsamkeit CHECK ALL APPROPRIATE TO ADVERSE REACTION 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 Results of tests and procedures relevant to the investigation of the patient: II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) sertralin Stada 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from JUN-2015 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) pipamperon from JUN-2015 bei Bedarf OTHER MEDICALLY IMPORTANT CONDITION 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 ( ): Depressive disorder ] Continuing: Unknown [ MedDRA 20.0 ( ): Hypothyreosis ] Continuing: Unknown [ MedDRA 20.0 ( ): Glaucoma ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 24-AUG-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Neutros rel. 64,5 rel%; Eos rel 2% Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT ( ): fatal 31-OCT OCT-2015 [ MedDRA 20.0 LLT ( ): Completed suicide ] * 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 9.03 /nl Platelet count /nl SGOT 20 U/l SGPT 28 U/l Creatine kinase 62 U/l C-reactive protein 0.23 mg/l Sodium 144 mmol/l Potassium 5 mmol/l Creatinine mg/dl sertralin Stada JUN A: C: Stada Arzneimittel AG 4 Month

3 Report Page: 3 of 7 Cumulative dose number (to first reaction) sertraline possible remergil AUG A: C: 2 Month Cumulative dose number (to first reaction) mirtazapine

4 Report Page: 4 of 7 possible l-thyroxin A: C: Cumulative dose number (to first reaction) levothyroxine sodium unlikely paracetamol A: bei Bedarf C: 500Mg milligram(s)

5 Report Page: 5 of 7 Einnahme seit Jahren Cumulative dose number (to first reaction) paracetamol unlikely 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug pipamperon JUN A: bei Bedarf C: 30Mg milligram(s) 1Day

6 Report Page: 6 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages pipamperone 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Depressive disorder ] Unknown Rezidivierende depressive Störung, gegenwärtig mittelgradige Episode [ MedDRA 20.0 ( ): Hypothyreosis ] Unknown [ MedDRA 20.0 ( ): Glaucoma ] Unknown primäres Engwinkelglaukom [ MedDRA 20.0 ( ): AV block ] Unknown [ MedDRA 20.0 ( ): Presbyacusis ] Unknown 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 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 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 36 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority

7 Report Page: 7 of 7 Street address City Bonn Postcode Country Fax Telephone 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