CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17069317 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10028813): Nausea ] etwas Neurodermitis (10029264): Neurodermatitis aggravated ] (10016326): Feeling cold ] Schwäche in den Beinen (10047862): Weakness ] (10048329): Tremor aggravated ] Muskelschmerzen in den Beinen (10028361): Muscular pain ] Schmerzen im Brustbereich (10008479): Chest pain ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DA MO YR DA MO YR Übelkeit, etwas Neurodermitis, Kältegefühl, Schwäche in den Beinen und verstärkter Tremor während der Einnahme von Levofloxacin. Nach Beendigung der Einnahme zunehmende Schwäche,vor allem in den Beinen,Muskelschmerzen in den Beinen, zeitweise leichte Schmerzen im Brustbereich,sehr starker Tremor. II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) levofloxacin (batch: nicht bekannt) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "1 Tablette" Oral 17. INDICATION(S) FOR USE Bronchopneumonia DE 78 (Year) Female 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 27-JAN-2017 7 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) (cont.) 20. 21. INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 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 19.1 (10029263): Neurodermatitis ] Continuing: [ MedDRA 19.1 (10062262): Spinal operation ] Continuing: [ MedDRA 19.1 (10064159): Physical fitness training ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 27-FEB-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17069317 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 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 19.1 PT (10028813): Nausea ] (10028813): Nausea ] etwas Neurodermitis [MedDRA 19.1 PT (10029263): Neurodermatitis ] (10029264): Neurodermatitis aggravated ] [MedDRA 19.1 PT (10016326): Feeling cold ] (10016326): Feeling cold ] Schwäche in den Beinen [MedDRA 19.1 PT (10003549): Asthenia ] (10047862): Weakness ] [MedDRA 19.1 PT (10044565): Tremor ] (10048329): Tremor aggravated ] Muskelschmerzen in den Beinen [MedDRA 19.1 PT (10028411): Myalgia ] (10028361): Muscular pain ] Schmerzen im Brustbereich [MedDRA 19.1 PT (10008479): Chest pain ] (10008479): Chest pain ] * 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 rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Duration Dose * Indication(s)
Report Page: 3 of 5 Suspect Drug and batch no. Start date End date Route(s) of Administration levofloxacin (batch: nicht bekannt) 27-JAN- 2017 7 Day A: 1 Tablette B: C: D: E: Oral Bronchopneumonia 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: 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 levofloxacin 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 19.1 (10029263): Neurodermatitis ] chronische Neurodermitis [ MedDRA 19.1 (10062262): Spinal operation ] [ MedDRA 19.1 (10064159): Physical fitness training ] nach zwei Operationen an der Wirbelsäule tägliches Rückentraining Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017015797 Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0
Report Page: 4 of 5 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 Deutschland 20170227 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? DE-CADRBFARM-2017015797 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 51 Deutschland Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Deutschland Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj.
Report Page: 5 of 5 Weight (kg) 52 Height (cm) 172 Last menstrual periode date Text for relevant medical history and concurrent conditions