CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17315775 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR Libidoverlust (10024870): Loss of libido ] Erschöpfungssyndrom (10016256): Fatigue ] Angstzuständen (10002866): Anxiety state ] Schlafstörung (10040984): Sleep disorder ] Depressionen (10012378): Depression ] 43 DA MO YR (Year) Female 2011 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Anonyme Meldung aus der Bevölkerung Nach Einsatz der Mirena kam es zu eindeutigem Libidoverlust, depressiver Verstimmung, im Zeitverlauf Depressionen, Erschöpfungszustand, Angstzuständen, Schlafstörung. Symptome wurden Ärzten geschildert, ein Zusammenhang zur Mirena wegen "rein lokaler Wirkung und geringer Dosierung" verneint, nach Ablauf wurde daher 2016 erneut Mirena eingesetzt. Danach deutliche Verschlimmerung der Nebenwirkung, Psychotherapie erforderlich. Nach Ziehen der Mirena auf Patientenwunsch fast vollständiges Abklingen der Nebenwirkung.Psychotherapie konnte beendet werden. Wegen fehlender Kontaktn, können keine weiteren Informationen eingeholt werden. II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) Mirena 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE Contraception DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 2011 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) (cont.) 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 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 05-SEP-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17315775 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...) Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Depressionen [MedDRA 20.0 PT (10012378): Depression ] (10012378): Depression ] Libidoverlust [MedDRA 20.0 PT (10024870): Loss of libido ] (10024870): Loss of libido ] Erschöpfungssyndrom [MedDRA 20.0 PT (10016256): Fatigue ] (10016256): Fatigue ] Angstzuständen [MedDRA 20.0 PT (10002855): Anxiety ] (10002866): Anxiety state ] Schlafstörung [MedDRA 20.0 PT (10040984): Sleep disorder ] (10040984): Sleep disorder ] * 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 rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) Mirena 2011 A: B: C: D: E: Contraception Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number
Report Page: 3 of 5 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 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 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) Mirena 2016 A: B: C: D: E: 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 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
Report Page: 4 of 5 levonorgestrel Drugrecurrecnce (MedDRA version for reaction(s)/event(s) recurred) [ MedDRA 20.0 (10012378): Depression ] [ MedDRA 20.0 (10024870): Loss of libido ] [ MedDRA 20.0 (10016256): Fatigue ] [ MedDRA 20.0 (10002866): Anxiety state ] [ MedDRA 20.0 (10040984): Sleep disorder ] Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017018460 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 20170905 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-2017018460 Yes 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 24 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority
Report Page: 5 of 5 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