SUSPECT ADVERSE REACTION REPORT

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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 [ MedDRA 20.0 LLT ( ): Pancytopenia ] 75 DA MO YR (Year) Male Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Die Vorstellung erfolgt bei auffälligen Blutwerten im Rahmen der Routinediagnostik beim niedergelassenen betreuenden Urologen/Onkologen bei Prostatakarzinom. Völliges Wohlbefinden bis auf Schmerzen im Rahmen des ossär metastasierten Prostata Karzinom (lumbosacral). Anamnestisch aktuell keine Blutung. Allerdings zuletzt am Sonntag Epistaxis, die von alleine sistierte. Kein Infektgeschehen. Kein Fieber, keine Luftnot. Laborchemisch zeigten sich leicht erhöhte Nierenretentionsparameter sowie eine Panzytopenie. Im Urinschnelltest kein Zeichen eines Harnwegsinfektes. Blasenkatheter Wechsel letzte Woche erfolgt. In Zusammenschau präsentiert sich eine Myelosupression bei Z.n. Radiotherapie DD Progression der Grunderkrankung. 8-1 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 II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) 177Lu-PSMA DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE Prostate cancer 18. THERAPY DATES (from/to) 19. THERAPY DURATION from APR-2016 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 ( ): Prostate cancer ] Continuing: Unknown [ MedDRA 20.0 ( ): Hay fever ] Continuing: Unknown [ MedDRA 20.0 ( ): Food allergy ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 19-SEP-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...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date [MedDRA 20.0 PT ( ): Pancytopenia ] fatal MAY-2017 [ MedDRA 20.0 LLT ( ): Pancytopenia ] * 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 16-MAY-2017 C-reactive protein 5.89 mg/dl <0.50 Normal high range More inform. available 16-MAY-2017 Calcium 2.15 mmol/l MAY-2017 Creatinine 1.21 mg/dl MAY-2017 Protein total 6.1 g/dl MAY-2017 GGT 94 U/l <60 16-MAY-2017 Serum alkaline phosphatase U/l 130 NOS 16-MAY-2017 Leucocyte count 1.17 /nl MAY-2017 Erythrocyte scan 1.75 /pl MAY-2017 Haemoglobin g/dl MAY-2017 Haematocrit 17.8 % MAY-2017 MCV fl MAY-2017 MCH 34.3 pg MAY-2017 Red cell distribution width 17.1 % Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start date End date Duration Dose * Route(s) of Administration Indication(s) 177Lu-PSMA-617 APR A: B: C: D: E: Prostate cancer Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form)

3 Report Page: 3 of 5 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 13 Month 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 lutetium (lu 177) Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Pancytopenia ] Primarysource Global Introspection (WHO GI) probable/likely 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 20.0 ( ): Prostate cancer ] Unknown [ MedDRA 20.0 ( ): Hay fever ] Unknown [ MedDRA 20.0 ( ): Food allergy ] Unknown Paprika, Tomate [ MedDRA 20.0 ( ): Lactose intolerance ] Unknown Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Start date End date xofigo zoladex bicalutamid zometa xtandi zytiga prednisolon zometa APR- MAR- JUN- AUG-

4 Report Page: 4 of 5 radium ra 223 dichloride JAN 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 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Krankenhausbericht liegt vor. Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? 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 69 Physician SENDER INFORMATION (... continuation...) 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 Elderly >65.Lj.

5 Report Page: 5 of 5 Weight (kg) Height (cm) Last menstrual periode date Text for relevant medical history and concurrent conditions Patient erhielt 3-malig Xofigo

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