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 [ MedDRA 19.1 LLT ( ): Agranulocytosis ] Reporter's comments: DE DA MO YR 77 DA MO YR (Year) Male Maßnahme und Verlauf: Nach Absetzen erholten sich die Leukozyten ohne sonstige Maßnahme vollständig. Sonstiges: Die Schmerzbehandlung war zwingend erforderlich, da wegen Einnahme von Clopidogrel bis zum Auftreten der Symptome die erforderliche Operation als zu gefährlich eingestuft wurde und erst nach 5 Tagen dann erfolgreich durchgeführt wurde. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) 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 14. SUSPECT DRUG(S) (include generic name) novalgin II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION Intravenous (not otherwise specified) 17. INDICATION(S) FOR USE Ileus 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 24-FEB-2017 to 27-FEB Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) diovan concor (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 19.1 ( ): Stent placement ] from SEP-2016 Continuing: Unknown [ MedDRA 19.1 ( ): Ileus ] Continuing: No [ MedDRA 19.1 ( ): Intestinal atresia NOS ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 13-MAR-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 19.1 PT ( ): Agranulocytosis ] [ MedDRA 19.1 LLT ( ): Agranulocytosis ] recovered/resolved 4 Day 1 Day 27-FEB-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 Normal low range Normal high range More inform. available Leucocyte count Leucocyte count NA NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of novalgin 24-FEB FEB Day A: Intravenous (not otherwise specified) Ileus 4 Day Drug withdrawn Cumulative dose number (to first reaction) Structure dosages number Number of separate dosages Number of units in the interval metamizole sodium

3 Report Page: 3 of 7 Causality assessment Reaction Source Method Result [ MedDRA 19.1 ( ): Agranulocytosis ] AkdÄ Global Introspection (WHO GI) possible 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) diovan A: Hypertension Anwendung seit einigen Jahren. Cululative dose number (to first reaction) Structure of separate dosages Number of separate dosages Number of units in the interval valsartan 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) concor A: Hypertension

4 Report Page: 4 of 7 Anwendung seit einigen Jahren. Cululative dose number (to first reaction) Structure of separate dosages Number of separate dosages Number of units in the interval bisoprolol fumarate 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) clopidogrel SEP A: Stent placement 5 Month Cululative dose number (to first reaction) Structure of separate dosages Number of separate dosages Number of units in the interval clopidogrel 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...)

5 Report Page: 5 of 7 ass SEP A: Stent placement 5 Month Cululative dose number (to first reaction) Structure of separate dosages Number of separate dosages Number of units in the interval acetylsalicylic acid 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 19.1 ( ): Stent placement ] SEP Unknown [ MedDRA 19.1 ( ): Ileus ] No Ileus durch Bride mit vollständigem Darmverschluss. [ MedDRA 19.1 ( ): Intestinal atresia NOS ] Unknown Report duplicates Duplicate source Duplicate number DE-DCGMA Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0

6 Report Page: 6 of 7 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 Yes No List of documents held by sender Does this case fulfill the local criteria for an expedited report? Yes Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? 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 84 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode Country Fax +49 / (0) / Telephone +49 / (0) / address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg)

7 Report Page: 7 of 7 Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions

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