CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17162877 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET DA MO YR 63 DA MO YR (Year) Female 18 04 [ MedDRA 20.0 LLT (10073734): HIT II mit Mikroembolien [ MedDRA 20.0 LLT (10063492): Heparin-induced thrombosis ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden Patientin wurde am 6.4. operiert und am 13.4. nach komplikationslosem Verlauf entlassen. Dann am 15.04. Wiedervorstellung in der Notaufnahme wegen Schmerzen und livider Zehe links (operierte Seite) mit klinischem Verdacht auf Mikroembolien. Dann ist keine Blutabnahme erfolgt und die Patientin ist gegen ärtzlichen Rat gegangen. Am 18.04. Wiedervorstellung mit massiver Schwellung im Unterschenkel und livider Zehe links. Die Patientin hatte tastbaren Puls an der Arteria dorsalis pedis. Dann Thrombozytopenie von 26 festgestellt. Hat Thrombozystenkonzentrat bekommen. Ab dem 18.4 Argatra IV Dauerperfusion. Am 19.4 ist eine HIT mittels ELISA-Test festgestellt worden. Bis zum 03.05. und ab 3.5. Arixtra 2,5mg 1x1 sc. bis zur Entlassung am 9.5. Zusammengefasst: Die Patientin hatte ein Thrombozytopenie und Mikroembolien im linken Fuss wobei Dig 1,2,4,5 teilweise nekrotisch sind und die weitere Demarkierung/Mummifizierung 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) clexane 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "0,4mg" [ 3.2 Mg milligram(s) { 0.4 Mg milligram(s), 1 in 1 Subcutaneous Day } ] privacy 17. INDICATION(S) FOR USE Thrombosis prophylaxis DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 06-APR- to 13-APR- 8 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 20.0 (10062585): Peripheral arterial occlusive disease ] from 01-JUN-2016 Continuing: [ MedDRA 20.0 (10020775): Hypertension arterial ] Continuing: [ MedDRA 20.0 (10012601): Diabetes mellitus ] Continuing: (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-17162877 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL 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...) abgewartet wird, wsl wird der 5. Zeh amputiert im weiteren Verlauf. Ein andere Ursache für Mikroembolien war nicht anwesend. Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** Start End HIT II mit Mikroembolien [MedDRA 20.0 PT (10062506): Heparin-induced thrombocytopenia ] recovered/resolved with sequel 3 Day 18-APR- [ MedDRA 20.0 LLT (10063492): Heparin-induced thrombosis ] [MedDRA 20.0 PT (10073734): [ MedDRA 20.0 LLT (10073734): recovered/resolved with sequel 3 Day 18-APR- * 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 19-APR- ELISA positiv/positive NA 18-APR- Platelet count 26 NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) clexane 06-APR- 13-APR- 8 Day A: 0,4mg B: 3.2Mg milligram(s) C: 0.4Mg milligram(s) D: 1 E: 1Day Subcutaneous Thrombosis prophylaxis 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 13 Day Time interval between last dose of drug and start of reaction/event 6 Day Action(s) taken with drug Drug withdrawn
Report Page: 3 of 5 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 enoxaparin Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10073734): [ MedDRA 20.0 (10063492): Heparin-induced thrombosis ] Certain certain 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) heparin 06-APR- A: 5000IE Einmalig intraoperativ kurz bevor die Arterie abgeklemmt wird B: C: 50000Iu international unit(s) D: E: Intravenous (not otherwise specified) Femoropopliteal artery bypass 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 13 Day 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 heparin
Report Page: 4 of 5 Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10063492): Heparin-induced thrombosis ] [ MedDRA 20.0 (10073734): Certain certain 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 (10062585): Peripheral arterial occlusive disease ] 01-JUN- 2016 pavk IIb links und IIa rechts [ MedDRA 20.0 (10020775): Hypertension arterial ] [ MedDRA 20.0 (10012601): Diabetes mellitus ] [ MedDRA 20.0 (10051361): Adipositas ] [ MedDRA 20.0 (10057852): Nicotine dependence ] No 50 Packungen pro Jahr [ MedDRA 20.0 (10043920): Toe operation ] 06-APR- Unknown 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 Deutschland 0510 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 postcode country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 21 Deutschland Physician
Report Page: 5 of 5 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 Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 95 Height (cm) 163 Last menstrual periode Text for relevant medical history and concurrent conditions