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 Leukopenie ( ): Leucopenia ] ( ): Granulocytopenia ] ( ): Septic shock ] ( ): Acute respiratory distress syndrome ] ( ): Staphylococcus aureus infection ] 21 DA MO YR (Year) Female Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Die Vorstellung der Patientin erfolget mit Halsschmerzen und Fieber über unsere Rettungsstelle. Die Patientin hatte aufgrund von Beschwerden des oberen Respirationstraktes über ca 1,5 bis zwei Wochen täglich Metamizol eingenommen. Im Blutbild zeiget sich eine Leukopenie mit ausgeprägter Granulozytopenie. Im weiteren Verlauf kam es bei der Patientin zum septischen Schock mit Nachweis von Staphylokokkus aureus in mehreren Blutkulturen und in der BAL. Die Patientin entwickelte ein ARDS. Trotz Stimulation mit G-CSF kommt es zur zu eier sehr langsamen Regeneration der Leukozyten. Die histologischen Befunde einer Knochenmarksbiopsie sind aktuell noch ausstehend. In der Zytologie zeigte sich kein Hinweis auf Malignität. 8-1 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.) Novaminsulfon 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION Oral 17. INDICATION(S) FOR USE Pain 18. THERAPY DATES (from/to) 19. THERAPY DURATION from NOV-2016 to 01-DEC-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 DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.1 ( ): Polyarthritis ] from 2012 Continuing: [ MedDRA 19.1 ( ): Upper respiratory tract infection ] [ MedDRA 19.1 ( ): Fever ] (cont.) 24a. ME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIOL þ INITIAL FOLLOW UP FIL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Results of tests and procedures relevant to the investigation of the patient: Knochenmarkbiopsie Handdifferenzierung Blutbild Röntgenuntersuchung Mikrobiologische. und infektiologische Diagnostik Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date Leukopenie [MedDRA 19.1 PT ( ): Leukopenia ] ( ): Leucopenia ] not recovered/not resolved 1 Day 01-DEC-2016 [MedDRA 19.1 PT ( ): Granulocytopenia ] ( ): Granulocytopenia ] [MedDRA 19.1 PT ( ): Septic shock ] ( ): Septic shock ] [MedDRA 19.1 PT ( ): Acute respiratory distress syndrome ] ( ): Acute respiratory distress syndrome ] [MedDRA 19.1 PT ( ): Staphylococcal infection ] ( ): Staphylococcus aureus infection ] * 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 01-DEC-2016 Leucocyte count 0,28 /nl 02-DEC-2016 Leucocyte count 0,12 /nl 02-DEC-2016 Differential white blood cell count X-ray Blood culture Bone marrow biopsy - - Staphylokokkus aureus Ergebnis

3 Report Page: 3 of 5 Cytology ausstehend Kein Anzeichen auf Malignität 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) Novaminsulfon NOV DEC A: B: C: D: E: Oral Pain Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Tabletten 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 metamizole Causality assessment Reaction Source Method Result [ MedDRA 19.1 ( ): Leucopenia ] Reporter Probable/likely 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 19.1 ( ): Polyarthritis ] 2012 Unklare Polyarthritis [ MedDRA 19.1 ( ): Upper respiratory tract infection ] [ MedDRA 19.1 ( ): Fever ]

4 Report Page: 4 of 5 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 Deutschland 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? 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 12 Deutschland Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Deutschland Fax Telephone address PATIENT INFORMATION (... continuation...) Investigation number

5 Report Page: 5 of 5 Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 50 Height (cm) 165 Last menstrual periode date Text for relevant medical history and concurrent conditions

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