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 ( ): Swallowing disorder ] ( ): Dyspnoea ] ( ): Swelling of lips ] ( ): Mucosal swelling ] ( ): Swelling of tongue ] Reporter's comments: DE DA MO YR 38 DA MO YR (Year) Female Maßnahme: sofortige Behandlung mit Prednisolon 150 mg und Levocetirizin, da akute Lebensgefahr bestand. Danach generalisierte Hautrötung und Hautüberwärmung - Kühlen und Levocetirizin weiter, Juckreiz und Exanthem entstehen nun nach 3 Tagen. 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 II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) voltaren 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 75 Mg millgram(s) every Total" { 75 Mg Oral milligram(s), 1 in 1 } 17. INDICATION(S) FOR USE Joint inflammation 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 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.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 19-JUN-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*** Start date End date [MedDRA 20.0 PT ( ): Dysphagia ] ( ): Swallowing disorder ] [MedDRA 20.0 PT ( ): Dyspnoea ] ( ): Dyspnoea ] [MedDRA 20.0 PT ( ): Lip swelling ] ( ): Swelling of lips ] [MedDRA 20.0 PT ( ): Oedema mucosal ] ( ): Mucosal swelling ] [MedDRA 20.0 PT ( ): Swollen tongue ] ( ): Swelling of tongue ] * 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) voltaren 16-JUN A: daily dose: 75 Mg millgram(s) every Total B: C: 75Mg milligram(s) D: 1 E: 1 Oral Joint inflammation Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application

3 Report Page: 3 of 5 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 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 diclofenac sodium Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Swallowing disorder ] [ MedDRA 20.0 ( ): Dyspnoea ] [ MedDRA 20.0 ( ): Swelling of lips ] [ MedDRA 20.0 ( ): Mucosal swelling ] [ MedDRA 20.0 ( ): Swelling of tongue ] Report duplicates Duplicate source Duplicate number DE-DCGMA Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Start date End date arcoxia [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Acute allergic reaction ] ibuprofen [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): No adverse reaction ] Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0

4 Report Page: 4 of 5 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 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? 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 14 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 Adult >18.Lj. bis einschl. 65.Lj. Weight (kg)

5 Report Page: 5 of 5 Height (cm) Last menstrual periode date Text for relevant medical history and concurrent conditions Keine Vorerkrankungen, keine weiteren Allergien.

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