CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17379924 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 35 DA MO YR (Year) Female 06 2017 Panikattacken (10033664): Panic attack ] Angst; Angst vor Stürzen bei den Kindern; Todesangst; Angst vor tödlichen Krankheiten [ MedDRA 20.1 LLT (10002855): Anxiety ] Spannungen in den Brüsten (10006298): Breast pain ] (10066996): Heart racing ] Stressanfällig -> Stressempfinden ohne Stress, Überforderungsgefühl (10042218): Stress symptoms ] Aggression (10001488): Aggression ] vermehrter Haarwuchs (10053821): Hair growth increased ] Ausbleiben der Periode (10001927): Amenorrhea ] Unruhe (10045556): Unrest ] nervös (10029197): Nervous ] (10043890): Tiredness ] (10012374): Depressed mood ] Zittern (10040529): Shaking inside ] Selbstmordgedanken (10042458): Suicidal ideation ] Übelkeit (10028813): Nausea ] 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.) mirena 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION Intra-uterine 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 2014 to OCT-2017 3 Year 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.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 30-OCT-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17379924 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 5 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Meldende berichtet: Anfangs Aggression und Brustschmerzen. Vermehrter Haarwuchs, Ausbleiben der Periode. Danach Unruhe und nervös ab Januar 2017. Plötzliches Auftreten einer Panikattacke - ohne Grund im Juni 2017. Panik, Todesangst, Angst sich nicht mehr um die Kinder kümmern zu können, Müdigkeit und nervös, Stressanfällig, depressive Verstimmung - Überforderung....und das ganze OHNE!!!! äußere Stressfaktoren. Keine persönlichen Schwierigkeiten oder Stressfaktoren! Egänzung der Meldenden: Nach dem erstmaligen Auftreten der o.g. Symptome im Juni 2017 spürte ich eine ständige Verschlechterung der Psyche. Die Spirale wurde im Oktober 2017 entfernt und seit 2 Wochen bin ich nahezu Beschwerdefrei! Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date Panikattacken [MedDRA 20.1 PT (10033664): Panic attack ] JUN-2017 (10033664): Panic attack ] Angst; Angst vor Stürzen bei den Kindern; Todesangst; Angst vor tödlichen Krankheiten [MedDRA 20.1 PT (10002855): Anxiety ] 2015 (10002855): Anxiety ] Spannungen in den Brüsten [MedDRA 20.1 PT (10006298): Breast pain ] (10006298): Breast pain ] [MedDRA 20.1 PT (10033557): Palpitations ] (10066996): Heart racing ] [MedDRA 20.1 PT (10012374): Depressed mood ] (10012374): Depressed mood ] Stressanfällig -> Stressempfinden ohne Stress, Überforderungsgefühl [MedDRA 20.1 PT (10042209): Stress ] (10042218): Stress symptoms ] Aggression [MedDRA 20.1 PT (10001488): Aggression ] (10001488): Aggression ] vermehrter Haarwuchs [MedDRA 20.1 PT (10019044): Hair growth abnormal ]
Report Page: 3 of 5 (10053821): Hair growth increased ] Ausbleiben der Periode [MedDRA 20.1 PT (10001928): Amenorrhoea ] (10001927): Amenorrhea ] Unruhe [MedDRA 20.1 PT (10038743): Restlessness ] (10045556): Unrest ] nervös [MedDRA 20.1 PT (10029216): Nervousness ] (10029197): Nervous ] [MedDRA 20.1 PT (10016256): Fatigue ] (10043890): Tiredness ] Zittern [MedDRA 20.1 PT (10029216): Nervousness ] (10040529): Shaking inside ] Selbstmordgedanken [MedDRA 20.1 PT (10042458): Suicidal ideation ] (10042458): Suicidal ideation ] Übelkeit [MedDRA 20.1 PT (10028813): Nausea ] (10028813): Nausea ] JAN-2017 JAN-2017 * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose 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 and batch no. Start date End date Duration Dose * Route(s) of Administration Indication(s) mirena 2014 OCT- 2017 3 Year A: B: C: D: E: Intra-uterine
Report Page: 4 of 5 Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name levonorgestrel Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017019353 Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Start date End date [ MedDRA 20.1 (10001927): Amenorrhea ] [ MedDRA 20.1 (10053821): Hair growth increased ] [ MedDRA 20.1 (10026892): Mastodynia ] [ MedDRA 20.1 (10024423): Libido loss of ] Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Deutschland
Report Page: 5 of 5 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 20171030 No 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 Was the case medically confirmed, if not initially from health professional? DE-CADRBFARM-2017019353 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 93 Deutschland Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Deutschland 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) 71 Height (cm) 177 Last menstrual periode date Text for relevant medical history and concurrent conditions