SUSPECT ADVERSE REACTION REPORT
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- Flora Bridges
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1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR Sturz unklarer Genese [ MedDRA 20.0 LLT ( ): Fall ] [ MedDRA 20.0 LLT ( ): Enuresis ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Symptomatik: Patientin mit F31.4 und multipler Sklerose mit ataktischer Gangstörung (gehfähig mit Rollator) und Parkinson-Syndrom, Aufnahme zur medikamentösen Optimierung. Umstellung von Duloxetin auf Bupropion. Ab zusätzlich Methylprednisolon-Stoß 3x1 g mit Zopiclon, Pantoprazol und Clexane-Gabe zur Behandlung der MS. Am um Uhr gestürzt, massiv eingenässt, Unfallhergang durch Patientin nicht sicher erinnerlich, auch nicht durch Pflege oder Mitpatientin beobachtet. Results of tests and procedures relevant to the investigation of the patient: 67 DA MO YR (Year) Female cct-durchfühung: Diagnose eines Schädel-Hirn-Traumas Typ 1 II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) zopiclon 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 7.5 Mg,1 Day 17. INDICATION(S) FOR USE DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 28-NOV- to 01-DEC- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) lamotrigin Anwendung seit längerem duloxetin to 05-DEC- (cont.) þ 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 ( ): Bipolar affective disorder ] [ MedDRA 20.0 ( ): Multiple sclerosis ] [ MedDRA 20.0 ( ): Ataxic gait ] (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Hannover, DE 24c. DATE RECEIVED BY MANUFACTURER 13-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reporter's comments: Maßnahme/Verlauf: Absetzen von Zopiclon. UAW abgeklungen. Allerdings 2 Wochen später erneutes Sturzereignis ohne Zopiclon, aber ohne Einnässen, ohne Erinnerungslücke durch Patientin. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Sturz unklarer Genese [MedDRA 20.0 PT ( ): Fall ] [ MedDRA 20.0 LLT ( ): Fall ] recovered/resolved 5 Day 10 Month 02-DEC- 02-DEC- [MedDRA 20.0 PT ( ): Enuresis ] [ MedDRA 20.0 LLT ( ): Enuresis ] recovered/resolved 5 Day 10 Month 02-DEC- 02-DEC- * 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 Computerised tomogram vorhanden/present NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of zopiclon 28-NOV- 01-DEC- C: 7.5Mg
3 Report Page: 3 of 11 Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number zopiclone Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Fall ] Primarysource possible 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) lamotrigin Anwendung seit längerem C: 150Mg lamotrigine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) Duration Dose *
4 Report Page: 4 of 11 Route(s) of duloxetin 05-DEC- C: 90Mg duloxetine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) duloxetin 06-DEC- C: 60Mg
5 Report Page: 5 of 11 Drug withdrawn duloxetine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) risperidon Anwendung seit längerem C: 1Mg risperidone 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) bupropion 19-NOV- 05-DEC- 17 Day
6 Report Page: 6 of 11 C: 150Mg bupropion 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) bupropion 06-DEC- C: 300Mg
7 Report Page: 7 of 11 bupropion 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) metoprolol Anwendung seit längerem C: 190Mg metoprolol 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) methylprednisolon 28-NOV- daily dose: 3 G gram(s) every Day 15G gram(s) C: 1G gram(s) 3
8 Report Page: 8 of 11 methylprednisolone 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) pantoprazol 28-NOV- C: E: Multiple sclerosis
9 Report Page: 9 of 11 pantoprazole 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) clexane 28-NOV- C: E: Multiple sclerosis enoxaparin 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Bipolar affective disorder ] F31.4 Bipolare affektive Störung, gegenwärtig schwere depressive Episode ohne psychotische Symptome [ MedDRA 20.0 ( ): Multiple sclerosis ] [ MedDRA 20.0 ( ): Ataxic gait ] [ MedDRA 20.0 ( ): Parkinson's syndrome ]
10 Report Page: 10 of 11 Report duplicates Duplicate source der Duplicate number M 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 No 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 80 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Hannover Postcode Country Fax Telephone address PATIENT INFORMATION (... continuation...)
11 Report Page: 11 of 11 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
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