CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17410911 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 Milde diabetische Ketoazidose [ MedDRA 20.1 LLT (10012671): Diabetic ketoacidosis ] Results of tests and procedures relevant to the investigation of the patient: 71 DA MO YR (Year) Male 16 11 Pat. hat aufgrund von Übelkeit und Schmerzen mehrere Tage kaum etwas gegessen, was hinsichtlich der Ketonurie von Bedeutung sein könnte. ph ven. 7,36, BE -7,2, Bikarbonat 16,8, BZ 412 mg/dl, Keton i.u.++ 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) Empagliflozin 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 10 Mg milligram(s),1 Day Oral 17. INDICATION(S) FOR USE Type 2 diabetes mellitus 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 30-OCT- to III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) HCT 12,5 mg 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 20.1 (10008118): Cerebral infarction ] from OCT- [ MedDRA 20.1 (10067116): Carotid arteriosclerosis ] [ MedDRA 20.1 (10067116): Carotid arteriosclerosis ] 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17410911 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 Milde diabetische Ketoazidose [MedDRA 20.1 PT (10012671): Diabetic ketoacidosis ] [ MedDRA 20.1 LLT (10012671): Diabetic ketoacidosis ] recovering/resolving 1 Day * 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 ph 7.36 (venös) Base excess -7.2 Bicarbonate 16.8 Blood glucose 412 mg/dl Urine ketone body zweifach postitiv 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Empagliflozin 30-OCT- 16-NOV- A: B: C: 10Mg milligram(s) D: E: 1Day Oral Type 2 diabetes mellitus 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 10 mg täglich Did reaction reappear after reintroduction?
Report Page: 3 of 5 * 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 empagliflozin Causality assessment Reaction Source Method Result [ MedDRA 20.1 (10012671): Diabetic ketoacidosis ] Reporter 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) HCT 12,5 mg A: B: C: D: E: Hypertension arterial 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 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 hydrochlorothiazide 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.1 (10008118): Cerebral infarction ] OCT- Zustand nach embolischen Kleinhirninfarkt
Report Page: 4 of 5 [ MedDRA 20.1 (10067116): Carotid arteriosclerosis ] Nicht-stenosierende therosklerotische Makroangiopathie der Carotiden [ MedDRA 20.1 (10046274): Upper gastrointestinal haemorrhage ] NOV- obere Gastrointestinalblutung [ MedDRA 20.1 (10020850): Hyperthyroidism ] latente Hyperthyreose [ MedDRA 20.1 (10002330): Aneurysm aortic ] Aneurysma Aorta ascendens [ MedDRA 20.1 (10020775): Hypertension arterial ] [ MedDRA 20.1 (10051361): Adipositas ] [ MedDRA 20.1 (10068678): Nicotine abuse ] [ MedDRA 20.1 (10028813): Nausea ] [ MedDRA 20.1 (10033371): Pain ] [ MedDRA 20.1 (10054792): Inappetence ] 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 1120 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 70 Physician SENDER INFORMATION (... continuation...)
Report Page: 5 of 5 Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions