CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16432834 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 62 DA MO YR (Year) Male 06 12 2016 massiver Anstieg der Leberwerte i.s. einer Hepatitis (10012412): Deranged liver function tests ] (10057364): Reduced general condition ] (10017693): 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION Reporter's comments: Sonstiges: kein Abbruch der Einnahme, da Tabeltten bereits aufgebraucht waren INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT þ OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) amoxicillin ratio c875 mg/ 125 mg 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 2 Df dosage form every Days" { 1 Df dosage Oral form, 2 in } 17. INDICATION(S) FOR USE Acute bronchitis 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) 20. 21. 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 (10016262): Fatty liver alcoholic ] Continuing: Unknown [ MedDRA 20.0 (10029560): Non-smoker ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 17-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16432834 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 date End date [MedDRA 20.0 PT (10017693): recovering/resolving (10017693): massiver Anstieg der Leberwerte i.s. einer Hepatitis [MedDRA 20.0 PT (10024690): Liver function test abnormal ] (10012412): Deranged liver function tests ] recovered/resolved [MedDRA 20.0 PT (10049438): General physical health deterioration ] recovered/resolved (10057364): Reduced general condition ] * 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 15-DEC-2016 1197 U/l <60 15-DEC-2016 Bilirubin total 3.7 NA <1.2 15-DEC-2016 Alkaline phosphatase 282 NA 40 130 15-DEC-2016 Aspartate aminotransferase 304 NA <50 15-DEC-2016 Alanine aminotransferase 273 NA <50 15-DEC-2016 LDH 254 NA <250 08-DEC-2016 204 U/l <60 08-DEC-2016 C-reactive protein 203.5 NA <5.0 08-DEC-2016 Leucocyte count 16.3 NA 3.9 9.8 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) amoxicillin ratio c875 mg/ 125 mg 06-DEC- 2016 A: daily dose: 2 Df dosage form every Days B: C: 1Df dosage form D: 2 E: 1Day Oral Acute bronchitis
Report Page: 3 of 5 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 Einnahme von insgesamt 20 Tabletten 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 clavulanate potassium Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10017693): [ MedDRA 20.0 (10012412): Deranged liver function tests ] [ MedDRA 20.0 (10057364): Reduced general condition ] 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 20.0 (10016262): Fatty liver alcoholic ] Unknown alkoholtox. Steatosis hepatis [ MedDRA 20.0 (10029560): Non-smoker ] Unknown Report duplicates Duplicate source Duplicate number DE-DCGMA-16172017 Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions
Report Page: 4 of 5 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 List of documents held by sender Does this case fulfill the local criteria for an expedited report? 20170517 Laboratory Findings, additional information 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 88 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode 10623 Country Fax +49 / (0)30 4004 / 56555 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.
Report Page: 5 of 5 Weight (kg) 80 Height (cm) 183 Last menstrual periode date Text for relevant medical history and concurrent conditions