CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17131311 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 79 DA MO YR (Year) Male 23 03 2017 Purpura Schönlein-Henoch Unter- und Oberschenkel. [ MedDRA 19.1 LLT (10019617): Henoch-Schonlein purpura ] beginnender Ausschlag am Bein [ MedDRA 19.1 LLT (10062705): Localized rash ] 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: Maßnahme: Verordnung von Urea 15% und Umstellung auf Lantus. INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (include generic name) toujeo II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 10 Iu international unit(s) every Days" [ 140 Iu Subcutaneous international unit(s) { 10 Iu international unit(s), 1 in 1 Day } ] 17. INDICATION(S) FOR USE Diabetes mellitus 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 10-MAR-2017 to 07-APR-2017 29 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) metformin ramilich (cont.) 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.) [ MedDRA 19.1 (10002916): Aortic valve replacement ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 07-APR-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17131311 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 7 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*** Purpura Schönlein-Henoch Unter- und Oberschenkel. [MedDRA 19.1 PT (10019617): Henoch-Schonlein purpura ] not recovered/not resolved 14 Day 23-MAR-2017 [ MedDRA 19.1 LLT (10019617): Henoch-Schonlein purpura ] beginnender Ausschlag am Bein [MedDRA 19.1 PT (10037844): Rash ] not recovered/not resolved 14 Day 23-MAR-2017 [ MedDRA 19.1 LLT (10062705): Localized rash ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** and start of reaction/event Results of tests Date Test Result Unit Normal low range 08-MAR-2017 HbA1C 7.8 % 14. Suspect Drug(s) (including generic name) (... continuation...) Normal high range More inform. available Suspect Drug Duration Dose * Route(s) of toujeo 10-MAR- 07-APR- 2017 2017 29 Day A: daily dose: 10 Iu international unit(s) every Days 140Iu international unit(s) C: 10Iu international unit(s) 1 1Day Subcutaneous Diabetes mellitus 14 Day Drug withdrawn
Report Page: 3 of 7 Cumulative dose number (to first reaction) C: Structure dosages number insulin glargine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) metformin A: C: 1700Mg Diabetes mellitus Cululative dose number (to first reaction) metformin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) ramilich A: C: 10Mg Blood pressure
Report Page: 4 of 7 Cululative dose number (to first reaction) ramipril 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) simvastatin A: C: 10Mg Cholesterol Cululative dose number (to first reaction)
Report Page: 5 of 7 simvastatin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) fenofibrat A: C: 250Mg Cholesterol Cululative dose number (to first reaction) fenofibrate 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 19.1 (10002916): Aortic valve replacement ] Unknown Künstliche Aortenklappe Report duplicates Duplicate source Duplicate number DE-DCGMA-17173348
Report Page: 6 of 7 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 where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents No 20170407 No List of documents held by sender Does this case fulfill the local criteria for an expedited report? No Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? Yes 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
Report Page: 7 of 7 Gestation period Patient age group Elderly >65.Lj. Weight (kg) 88 Height (cm) 170 Last menstrual periode Text for relevant medical history and concurrent conditions