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 ( ): Drug withdrawal syndrome ] [ MedDRA 20.0 LLT ( ): Anxiety state ] Unruhezustand [ MedDRA 20.0 LLT ( ): Restlessness ] 67 DA MO YR (Year) Female Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Beobachtete unerwünschte Wirkung: Nach Absetzen von Olanzapin starke Unruhe und Angstzustände für ca. 4 Wochen. Erster Absetzversuch von Olanzapin 5mg e 2015 wegen schwerer Unruhe und Agst nach 4 Wochen abgebrochen. Neue Dosis danach 10mg. Zweites Absetzen im März 2017 erfolgreich, allerdings wiederum mit massiver Unruhe und Angst. Verdacht auf Entzugssymptome. Es wurde ab Lithium zur Augmentation gegeben CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (include generic name) Olanzapin II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 10 Mg,1 Day 17. INDICATION(S) FOR USE Anxiety disorder 18. THERAPY DATES (from/to) 19. THERAPY DURATION from JUL-2014 to MAR Year III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) mirtazapin from 2010 Sertralin from FEB-2016 (cont.) 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 ( ): Depression ] Continuing: Unknown [ MedDRA 20.0 ( ): Anxiety disorder ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 20-JUL-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of 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 ( ): Drug withdrawal syndrome ] [ MedDRA 20.0 LLT ( ): Drug withdrawal syndrome ] [MedDRA 20.0 PT ( ): Anxiety ] [ MedDRA 20.0 LLT ( ): Anxiety state ] Unruhezustand [MedDRA 20.0 PT ( ): Restlessness ] [ MedDRA 20.0 LLT ( ): Restlessness ] 4 Week recovered/resolved 4 Week recovered/resolved recovered/resolved MAR-2017 MAR-2017 MAR-2017 * 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 rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of Olanzapin JUL MAR Year A: C: 10Mg E: 1Day Anxiety disorder Drug withdrawn

3 Report Page: 3 of 6 Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages olanzapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Drug withdrawal syndrome ] Primarysource Global Introspection (WHO GI) probable/likely [ MedDRA 20.0 ( ): Anxiety state ] Primarysource Global Introspection (WHO GI) probable/likely [ MedDRA 20.0 ( ): Restlessness ] Primarysource Global Introspection (WHO GI) probable/likely 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of mirtazapin 2010 A: C: 45Mg E: 1Day Depression Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages mirtazapine 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of

4 Report Page: 4 of 6 Sertralin FEB A: C: 50Mg E: 1Day Depression Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages sertraline 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of Lithium MAR A: C: 675Mg E: Anxiety disorder

5 Report Page: 5 of 6 Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages lithium 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Depression ] Unknown [ MedDRA 20.0 ( ): Anxiety disorder ] 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 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Yes Was the case medically confirmed, if not initially from health professional? 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 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn

6 Report Page: 6 of 6 Postcode Country Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 63 Height (cm) 153 Last menstrual periode Text for relevant medical history and concurrent conditions