CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17186825 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 82 DA MO YR (Year) Female 07 07 Quantitative Bewusstseinsstörung (10010770): Consciousness disturbed ] (10009866): Cold sweat ] (10033533): Pale skin ] (10017577): Gait disturbance ] (10048948): Bedridden ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Symptomatik: Bereits am Tag des Ansetzens von Nitoman deutliche Vigilanzminderung, wobei die Patientin auf Schmerzreize erweckbar war. Dabei war die Patientin kaltschweißig, zeigte einen blassen Hautteint, auf das Pflegepersonal wirkte die Patientin ''präfinal''. Sie wirkte steif, ein selbstständiges Stehen und Gehen war nicht mehr möglich. Die Patientin war bettlägerig und musste gelagert werden, das Essen musste ihr gereicht werden, zum Teil auch püriert. Zwischenzeitlich war die Patientin wacher und gab auf Ansprache adäquate Antworten. Zuvor wies die Patientin eine ausgeprägte psychomotorische Unruhe auf, lief unablässig auf dem Stationsflur entlang und war kaum in der Lage ruhig im Bett zu liegen, oder im Stuhl zu sitzen. Dies war auch die Aufnahmeindikation. Im Rahmen der Vigilanzminderung war die Patientin (über 11 Tage hinweg) 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) tetrabenazin 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 50 Mg,1 Day 17. INDICATION(S) FOR USE DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 07-JUL- to 12-JUL- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) pantoprazol from 16-MAR- pantoprazol from 16-MAR- (cont.) þ þ 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 (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10012271): Dementia Alzheimer's type ] [ MedDRA 20.0 (10020775): Hypertension arterial ] [ MedDRA 20.0 (10039872): Secondary parkinsonism ] (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 30625 Hannover, DE 24c. DATE RECEIVED BY MANUFACTURER 13-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17186825 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 8 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) auch infusionspflichtig. Ein zur differentialdiagnostischen Abklärung durchgeführtes MRT ergab keinen richtungsweisenden Akutbefund. Schließlich beendeten wir am 12.07. die Nitoman-Gabe, worunter sich innerhalb von ca. 5 Tagen eine weitgehende Remission einstellte. Reporter's comments: Maßnahmen: Absetzen von Tetrabenazin. Verlauf: UAW abgeklungen. Im direkten Anschluss keine weitere Psychopharmakatherapie. Reaction text as reported MedDRA coding Quantitative Bewusstseinsstörung [MedDRA 20.0 PT (10001854): Altered state of consciousness ] (10010770): Consciousness disturbed ] Duration Outcome* Term highlighted Time interval 1** Time interval 2*** 07-JUL- 18-JUL- [MedDRA 20.0 PT (10009866): Cold sweat ] (10009866): Cold sweat ] 07-JUL- 18-JUL- [MedDRA 20.0 PT (10033546): Pallor ] (10033533): Pale skin ] 07-JUL- 18-JUL- [MedDRA 20.0 PT (10017577): Gait disturbance ] (10017577): Gait disturbance ] 07-JUL- 18-JUL- [MedDRA 20.0 PT (10048948): Bedridden ] (10048948): Bedridden ] 07-JUL- 18-JUL- * 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 tetrabenazin 07-JUL- 12-JUL- A: C: 50Mg
Report Page: 3 of 8 Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages tetrabenazine Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10010770): Consciousness disturbed ] Primarysource probable/likely 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) pantoprazol 16-MAR- A: C: 20Mg
Report Page: 4 of 8 Cululative dose number (to first reaction) Number of separate dosages pantoprazole 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) simvastatin 16-MAR- A: C: 40Mg Cululative dose number (to first reaction) Number of separate dosages simvastatin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) xarelto 17-MAR- A: C: 20Mg
Report Page: 5 of 8 Cululative dose number (to first reaction) Number of separate dosages rivaroxaban 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) metoprolol A: Anwendung seit Jahren C: 47.5Mg
Report Page: 6 of 8 Cululative dose number (to first reaction) Number of separate dosages metoprolol 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) alendronsaeure A: Anwendung seit Jahren C: 70Mg E: 1Week Cululative dose number (to first reaction) Number of separate dosages alendronic acid 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) vitamin b 12 13-JUL- A: C: 1000µg microgram(s) E: 1Week
Report Page: 7 of 8 Cululative dose number (to first reaction) Number of separate dosages cyanocobalamin 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10012271): Dementia Alzheimer's type ] [ MedDRA 20.0 (10020775): Hypertension arterial ] I10.00 [ MedDRA 20.0 (10039872): Secondary parkinsonism ] G21.8 [ MedDRA 20.0 (10037212): Psychomotor restlessness ] Report duplicates Duplicate source der Duplicate number LBB-05-001 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 Yes 20170513 No
Report Page: 8 of 8 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Yes Regulatory authority's case report number Other case identifiers in previous transmissions Yes Was the case medically confirmed, if not initially from health professional? No 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 15 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Hannover Postcode 30625 Country Fax Telephone E-mail address PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions