CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16240186 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 56 DA MO YR (Year) Female 30 06 2016 entzündete Mundwinkel mit Einriss [ MedDRA 19.0 LLT (10002509): Angular cheilitis ] 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 INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (include generic name) levofloxacin II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 500 Mg millgram(s) every Days" [ 1000 Mg { 500 Mg, 1 in 1 Day } ] 17. INDICATION(S) FOR USE Aspiration 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 29-JUN-2016 to 03-JUL-2016 5 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) trulicity from 05-JUN-2016 daily dose: 1.5 Mg millgram(s) every Weeks inegy 10 mg/40 mg daily dose: 1 Df dosage form every Days (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 19.0 (10029328): Neuropathy ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 30-JUN-2016 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16240186 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 9 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*** entzündete Mundwinkel mit Einriss [MedDRA 19.0 PT (10002509): Angular cheilitis ] 12 Day recovered/resolved 2 Day 30-JUN-2016 11-JUL-2016 [ MedDRA 19.0 LLT (10002509): Angular cheilitis ] * 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 Normal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of levofloxacin 29-JUN- 2016 03-JUL- 2016 5 Day A: daily dose: 500 Mg millgram(s) every Days 1000Mg C: 500Mg Aspiration 2 Day Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number
Report Page: 3 of 9 levofloxacin Causality assessment Reaction Source Method Result AkdÄ Global Introspection (WHO GI) 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) trulicity 05-JUN- 2016 A: daily dose: 1.5 Mg millgram(s) every Weeks C: 1.5Mg E: 1Week Subcutaneous Type 2 diabetes mellitus 26 Day dulaglutide 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) inegy 10 mg/40 mg A: daily dose: 1 Df dosage form every Days C: 1Df dosage form LDL cholesterol increased
Report Page: 4 of 9 Einnahme seit Jahren simvastatin ezetimibe 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) valsartan A: 1 1/2/d C: 80Mg D: E: Blood pressure increased Einnahme seit Jahren
Report Page: 5 of 9 valsartan 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) pantoprazol 5 Year A: 1-2/d C: 20Mg D: E: Gastric operation Indikation: Z.n. Schlauchmagen-OP pantoprazole 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) limptar A: daily dose: 200 Mg millgram(s) every Days C: 200Mg Muscle cramps
Report Page: 6 of 9 Einnahme seit Jahren; Indikation: Muskelkrämpfe bei Neuropathie quinine sulfate 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) one-alpha 0,5mcg kapseln 3 Year A: daily dose: 1 Df dosage form every Days C: 1Df dosage form Hyperparathyroidism secondary
Report Page: 7 of 9 alfacalcidol 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) l-thyroxin 50 plus 6 Year A: daily dose: 1 Df dosage form every Days C: 1Df dosage form Hypothyroidism levothyroxine sodium Iodid Ion 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 19.0 (10029328): Neuropathy ] Unknown Report duplicates Duplicate source Duplicate number
Report Page: 8 of 9 DE-DCGMA-16170235 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 20160630 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 Consumer or other non health professional 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
Report Page: 9 of 9 PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 98 Height (cm) 165 Last menstrual periode Text for relevant medical history and concurrent conditions