SUSPECT ADVERSE REACTION REPORT

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Dominik Bayer
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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 52 DA MO YR (Year) Female schleichender Beginn der Depression ( ): Depression ] schleichender Beginn der Gedächtnisstörungen ( ): Memory disturbance ] ( ): Avolition ] ( ): Concentration impairment ] ( ): Loss of all interest ] ( ): Suicidal ideation ] ( ): Loss of memory ability ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Schleichender Beginn der Depression und Gedächtnisstörungen; Antriebsverlust, Konzentrationsschwierigkeiten, Verlust jeglicher Interessen; am morgens hochgradig depressiv mit der Idee, nicht mehr leben zu wollen, demnächst nicht mehr aufwachen zu wollen. Gedächtnisstörungen haben ebenfalls schleichend eingesetzt mit teilweisem, nicht reversiblen Erinnnerungsverlust zu Taten und Ereignissen im Privatleben und auf der Arbeit CHECK ALL APPROPRIATE TO ADVERSE REACTION 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.) exemestane 25 mg 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 25 Mg milligram(s) every Day" [ 800 Mg Oral milligram(s) { 25 Mg milligram(s), 1 in 1 Day } ] 17. INDICATION(S) FOR USE Breast cancer 18. THERAPY DATES (from/to) 19. THERAPY DURATION from MAR- to APR- 36 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 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.) [ MedDRA 20.0 ( ): Breast cancer ] from 2012 Continuing: [ MedDRA 20.0 ( ): Adnexectomy ] from 2016 Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 29-MAY- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE 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...) Depression nach Absetzen in Besserung; Gedächtnisstörungen aus der Vergangenheit bleiben bestehen, aktuelle Störungen treten seltener auf. Weiterer Bericht des Meldenden: Es handelt sich um Exemestan 25 mg, einen Aromatasehemmer der Firma Pfizer, den ich in der Nachbehandlung der nicht metastasierten Brustkrebserkrankung (von 2012) im März und April diesen Jahres an 36 aufeinanderfolgenden Tagen eine Tablette morgens eingenommen habe. Zuvor hatte ich im Oktober 2016 Tamoxifen wegen ausgeprägter Luftnot und Ödemen absetzen müssen, beide Nebenwirkungen traten bei einem erneuten Behandlungsversuch von 4 Tagen (3 Monate nach Adnektomie) im Februar diesen Jahres wieder auf und führten zum erneuten Therapieabbruch. Zwischen erneutem Absetzen von Tamoxifen und Behandlungsbeginn mit Exemestan lagen ca. 5 Wochen. Sender's comment: ErwachsenBegleiterkrankung/Grunderkrankung: Wechsel der Behandlung nach Brustkrebs von Tamoxifen (wegen Unverträglichkeit) nach Entfernung der Eierstöcke auf Aromatasehemmer, jetzt ebenfalls wegen Nebenwirkungen abgesetzt. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date schleichender Beginn der Depression [MedDRA 20.0 PT ( ): Depression ] recovering/resolving ( ): Depression ] schleichender Beginn der Gedächtnisstörungen [MedDRA 20.0 PT ( ): Memory impairment ] ( ): Memory disturbance ] [MedDRA 20.0 PT ( ): Apathy ] ( ): Avolition ] [MedDRA 20.0 PT ( ): Disturbance in attention ] ( ): Concentration impairment ] [MedDRA 20.0 PT ( ): Decreased interest ] ( ): Loss of all interest ] [MedDRA 20.0 PT ( ): Suicidal ideation ] 24-APR- ( ): Suicidal ideation ] [MedDRA 20.0 PT ( ): Amnesia ] ( ): Loss of memory ability ]

3 Report Page: 3 of 5 * 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) exemestane 25 mg MAR- APR- 36 Day A: daily dose: 25 Mg milligram(s) every Day B: 800Mg milligram(s) C: 25Mg milligram(s) D: 1 E: 1Day Oral Breast cancer Identification of the country where the drug was obtained Name of holder/applicant Pfizer 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 Drug withdrawn 1-0-0, Zust.n. Brustkrebs 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 exemestane 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 20.0 ( ): Breast cancer ] 2012 nicht metastasierte Brustkrebserkrankung [ MedDRA 20.0 ( ): Adnexectomy ] 2016

4 Report Page: 4 of 5 Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Start date End date [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Dyspnea ] [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Edema ] [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Dyspnea ] [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Edema ] OCT OCT FEB- FEB- 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 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 0529 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 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 52 Consumer or other non health professional SENDER INFORMATION (... continuation...)

5 Report Page: 5 of 5 Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 78 Height (cm) 175 Last menstrual periode date Text for relevant medical history and concurrent conditions

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