CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17192278 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy [ MedDRA 20.0 LLT (10016821): Flushed ] [ MedDRA 20.0 LLT (10013710): Drug interaction ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DE DA MO YR 27 DA MO YR (Year) Male 18 05 2017 Borreliose mit stark ausgebildeter Erythema migrans in Stadium 1. Daher die Gabe von 2 mal 100mg Doxycyclin AL 100 T täglich für 21 Tage. Aufgrund der Begleiterkrankung Enzephalomyelitis disseminata (ICD G35.10) wird 2 mal täglich 240mg Tecfidera eingenommen. Bislang sind keine "Flushs" in der 6 monatigen Behandlung mit diesem Präperat aufgetreten. Unter Einnahme des Doxycyclin ist dies jedoch bei jeder Einnahme des Tecfideras aufgetreten. 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 II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10067559): Lyme borreliosis ] Continuing: Unknown [ MedDRA 20.0 (10062488): Erythema migrans ] Continuing: Unknown (cont.) 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-17192278 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 End [MedDRA 20.0 PT (10016825): Flushing ] 7 Day recovered/resolved 18-MAY-2017 24-MAY-2017 [ MedDRA 20.0 LLT (10016821): Flushed ] [MedDRA 20.0 PT (10013710): Drug interaction ] 7 Day recovered/resolved 18-MAY-2017 24-MAY-2017 [ MedDRA 20.0 LLT (10013710): Drug interaction ] * 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 Interacting Drug(s) and Dates of Administration (... continuation...) Interacting Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Doxycyclin AL 100 T 21 Day A: daily dose: 200 Mg milligram(s) every Day B: C: 100Mg milligram(s) D: 2 E: 1Day Lyme borreliosis 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
Report Page: 3 of 5 D: Number of separate dosages E: Number of units in the interval Active drug substance name doxycycline Interacting Drug(s) and Dates of Administration (... continuation...) Interacting Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) tecfidera A: daily dose: 480 Mg milligram(s) every Day B: C: 240Mg milligram(s) D: 2 E: 1Day Multiple sclerosis 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 dimethyl fumarate 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 (10067559): Lyme borreliosis ] Unknown Borreliose Stadium 1 [ MedDRA 20.0 (10062488): Erythema migrans ] Unknown Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017016819
Report Page: 4 of 5 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 20170531 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-2017016819 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 92 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...)
Report Page: 5 of 5 Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions