CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16275990 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy [ MedDRA 19.0 LLT (10019727): Hepatitis acute ] [ MedDRA 19.0 LLT (10058693): Exanthema generalised ] Results of tests and procedures relevant to the investigation of the patient: Aussschluss: PBC und PSC, keine Cholestase, keine weiteren Noxen Reporter's comments: DE DA MO YR 34 DA MO YR (Year) Female 16 06 2016 UAW-Verlauf: ambulante Behandlung mit Amoxicillin bei Sinusitis vor 7 Wochen. 2 Wochen danach generalisiertes Exanthem. Vor wenigen Tagen Oberbauchbeschwerden und Sklerenikterus. Allgemeine Schwäche. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. 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.) amoxicillin 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE Sinusitis 18. THERAPY DATES (from/to) 19. THERAPY DURATION 7 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) l-thyroxin 20. 21. 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.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16275990 24d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 5 7. + 13. 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 End [MedDRA 19.0 PT (10019727): Hepatitis acute ] not recovered/not resolved 16-JUN-2016 [ MedDRA 19.0 LLT (10019727): Hepatitis acute ] [MedDRA 19.0 PT (10037858): Rash generalised ] not recovered/not resolved 16-JUN-2016 [ MedDRA 19.0 LLT (10058693): Exanthema generalised ] * 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 Bilirubin 107 µmol/l Bilirubin 110 µmol/l Alkaline phosphatase 150 U/l Alkaline phosphatase 118 U/l C-reactive protein 5.8 PT/l C-reactive protein 5.6 PT/l Hepatitis viral test Ausschluss NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) amoxicillin 7 Day A: B: C: D: E: Sinusitis Identification of the country where the drug was obtained Name of holder/applicant 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
Report Page: 3 of 5 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 amoxicillin Causality assessment Reaction Source Method Result [ MedDRA 19.0 (10019727): Hepatitis acute ] AkdÄ Global Introspection (WHO GI) possible [ MedDRA 19.0 (10058693): Exanthema generalised ] AkdÄ Global Introspection (WHO GI) possible 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) l-thyroxin A: B: C: 75µg microgram(s) D: E: Hypothyroidism Identification of the country where the drug was obtained Name of holder/applicant 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 Daueranwendung Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name
Report Page: 4 of 5 levothyroxine sodium Report duplicates Duplicate source Duplicate number DE-DCGMA-16170586 Parent Parent identification Date of birth Age LMP 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 20160805 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 10 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode 10623 Country Fax +49 / (0)30 4004 / 56555
Report Page: 5 of 5 Telephone +49 / (0)30 4004 / 56500 E-mail address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 70 Height (cm) 170 Last menstrual periode Text for relevant medical history and concurrent conditions