SUSPECT ADVERSE REACTION REPORT
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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 DE DA MO YR [ MeDRA 20.1 LLT ( ): Bilirubin increase ] [ MeDRA 20.1 LLT ( ): Subfebrile ] [ MeDRA 20.1 LLT ( ): Scleral icterus ] 43 DA MO YR (Year) Male CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (incluing relevant tests/lab ata) PATIENT DIED þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION Reporter's comments: Maßnahme: Es erfolgte ie Verlegung in ie Neurologische Uniklinik (auch bei klinischer Verschlechterung es GBS, trotz er IVIG-Behanlung). Nach münlicher Auskunft hätten sich ie Bilirubinwerte im weiteren Verlauf wieer normalisiert. INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (inclue generic name) kiovig (batch: LE12S163AC) II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "aily ose: 30 G gram(s) every Days" [ 150 G gram(s) { 30 Intravenous (not otherwise specifie) G gram(s), 1 in 1 Day } ] 17. INDICATION(S) FOR USE Guillain-Barre synrome 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 23-OCT- to 27-OCT- 5 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclue those use to treat reaction) metohexal aily ose: 95 Mg millgram(s) every Days elix aily ose: 10 Mg millgram(s) every Days (cont.) DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA (cont.) 23. OTHER RELEVANT HISTORY (e.g. iagnostics, allergics, pregnancy with last month of perio, etc.) [ MeDRA 20.1 ( ): Rhinitis allergic ] Continuing: Unknown [ MeDRA 20.1 ( ): Hypertension arterial ] Continuing: Unknown [ MeDRA 20.1 ( ): Retinopathy ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 08-NOV- DATE OF THIS REPORT 21-NOV- 24b. MFR CONTROL NO. DE-BFARM REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attache sheet(s)
2 21-NOV- Report Page: 2 of Describe Reaction(s) (incluing relevant tests/lab ata) (... continuation...) Reaction text as reporte MeDRA coing Duration Outcome* Term highlighte Time interval 1** Time interval 2*** En [MeDRA 20.1 PT ( ): Bloo bilirubin increase ] recovere/resolve 29-OCT- [ MeDRA 20.1 LLT ( ): Bilirubin increase ] [MeDRA 20.1 PT ( ): Pyrexia ] recovere/resolve 29-OCT- [ MeDRA 20.1 LLT ( ): Subfebrile ] [MeDRA 20.1 PT ( ): Ocular icterus ] recovere/resolve 29-OCT- [ MeDRA 20.1 LLT ( ): Scleral icterus ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect rug aministration an start of reaction/event *** Time interval between last ose an start of reaction/event Results of tests Date Test Result Unit Normal low range Normal high range More inform. available 29-OCT- Bilirubin total 4.8 mg/l 29-OCT- Bilirubin irect 0.5 mg/l 14. Suspect Drug(s) (incluing generic name) (... continuation...) Suspect Drug an batch no. En Duration Dose * Route(s) of Aministration Inication(s) kiovig (batch: LE12S163AC) 23-OCT- 27-OCT- 5 Day A: aily ose: 30 G Intravenous (not gram(s) every Days otherwise specifie) 150G gram(s) C: 30G gram(s) D: 1 Guillain-Barre synrome Ientification of the country where the rug was obtaine Name of holer/applicant Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure Time interval between beginning of rug aministration an start of reaction/event Time interval between last ose of rug an start of reaction/event 7 Day 3 Day
3 21-NOV- Report Page: 3 of 9 Action(s) taken with rug Aitional information on rug Di reaction reappear after reintrouction? Cumulative ose number (to first reaction) C: Structure osages number D: Number of separate osages Active rug substance name immunoglobulin g human Causality assessment Reaction Source Metho Result [ MeDRA 20.1 ( ): Bilirubin increase ] AkÄ conitional/unclassifie [ MeDRA 20.1 ( ): Subfebrile ] AkÄ conitional/unclassifie [ MeDRA 20.1 ( ): Scleral icterus ] AkÄ conitional/unclassifie 14. Suspect Drug(s) (incluing generic name) (... continuation...) Suspect Drug an batch no. En Duration Dose * Route(s) of Aministration Inication(s) mirtazapin Hexal 26-JAN- 28-OCT- 9 Month A: aily ose: 15 G gram(s) every Days 4140G gram(s) C: 15G gram(s) D: 1 Oral Depression Ientification of the country where the rug was obtaine Name of holer/applicant Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure Time interval between beginning of rug aministration an start of reaction/event Time interval between last ose of rug an start of reaction/event 9 Month 2 Day Action(s) taken with rug Aitional information on rug aitional Inikation: Schlafstörungen Di reaction reappear after reintrouction? Cumulative ose number (to first reaction) C: Structure osages number D: Number of separate osages Active rug substance name
4 21-NOV- Report Page: 4 of 9 mirtazapine Causality assessment Reaction Source Metho Result [ MeDRA 20.1 ( ): Bilirubin increase ] AkÄ conitional/unclassifie [ MeDRA 20.1 ( ): Subfebrile ] AkÄ conitional/unclassifie [ MeDRA 20.1 ( ): Scleral icterus ] AkÄ conitional/unclassifie 14. Suspect Drug(s) (incluing generic name) (... continuation...) Suspect Drug an batch no. En Duration Dose * Route(s) of Aministration Inication(s) clexane 27-JAN- 28-OCT- 9 Month A: aily ose: 40 G gram(s) every Days 11000G gram(s) C: 40G gram(s) D: 1 Subcutaneous Thrombosis prophylaxis Ientification of the country where the rug was obtaine Name of holer/applicant Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure Time interval between beginning of rug aministration an start of reaction/event 9 Month Time interval between last ose of rug an start of reaction/event 2 Day Action(s) taken with rug Aitional information on rug Di reaction reappear after reintrouction? Cumulative ose number (to first reaction) C: Structure osages number D: Number of separate osages Active rug substance name enoxaparin Causality assessment Reaction Source Metho Result [ MeDRA 20.1 ( ): Bilirubin increase ] AkÄ conitional/unclassifie [ MeDRA 20.1 ( ): Subfebrile ] AkÄ conitional/unclassifie [ MeDRA 20.1 ( ): AkÄ conitional/unclassifie
5 Scleral icterus ] 21-NOV- Report Page: 5 of (s) an Dates of Aministration (exclue those use to treat reaction) (... continuation...) an batch no. En Aministration Inication(s) metohexal 2 Week A: aily ose: 95 Mg millgram(s) every Days C: 95Mg milligram(s) D: 1 Hypertension Ientification of the country where the rug was obtaine Name of holer/applicant Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure Time interval between beginning of rug aministration an start of reaction/event Time interval between last ose of rug an start of reaction/event Action(s) taken with rug Aitional information on rug Di reaction reappear after reintrouction? Cululative ose number (to first reaction) C: Structure of separate osages D: Number of separate osages Active rug substance name metoprolol tartrate 22. (s) an Dates of Aministration (exclue those use to treat reaction) (... continuation...) an batch no. En Aministration Inication(s) elix 2 Week A: aily ose: 10 Mg millgram(s) every Days C: 5Mg milligram(s) D: 2 Hypertension Ientification of the country where the rug was obtaine Name of holer/applicant
6 21-NOV- Report Page: 6 of 9 Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure Time interval between beginning of rug aministration an start of reaction/event Time interval between last ose of rug an start of reaction/event Action(s) taken with rug Aitional information on rug Di reaction reappear after reintrouction? Cululative ose number (to first reaction) C: Structure of separate osages D: Number of separate osages Active rug substance name ramipril 22. (s) an Dates of Aministration (exclue those use to treat reaction) (... continuation...) an batch no. En Aministration Inication(s) ibuhexal 28-OCT- 29-OCT- 2 Day A: C: 400Mg milligram(s) D: E: Oral Hypertension Ientification of the country where the rug was obtaine Name of holer/applicant Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure Time interval between beginning of rug aministration an start of reaction/event 2 Day Time interval between last ose of rug an start of reaction/event Action(s) taken with rug Aitional information on rug Di reaction reappear after reintrouction? Cululative ose number (to first reaction) C: Structure of separate osages D: Number of separate osages Active rug substance name
7 21-NOV- Report Page: 7 of 9 ibuprofen 22. (s) an Dates of Aministration (exclue those use to treat reaction) (... continuation...) an batch no. En Aministration Inication(s) melneurin 23-OCT- 24-OCT- 2 Day A: 25 mg / 50 mg C: D: E: Oral Sleep isorer Ientification of the country where the rug was obtaine Name of holer/applicant Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure Time interval between beginning of rug aministration an start of reaction/event 7 Day Time interval between last ose of rug an start of reaction/event 6 Day Action(s) taken with rug Aitional information on rug Di reaction reappear after reintrouction? Cululative ose number (to first reaction) C: Structure of separate osages D: Number of separate osages Active rug substance name melperone hyrochlorie 22. (s) an Dates of Aministration (exclue those use to treat reaction) (... continuation...) an batch no. En Aministration Inication(s) zopiclon-ratiopharm 26-OCT- 27-OCT- 2 Day A: C: 7.5Mg milligram(s) D: E: Oral Sleep isorer Ientification of the country where the rug was obtaine Name of holer/applicant Parent route of aministration (in case of a parent chil/fetus report) Gestation perio at time of exposure
8 21-NOV- Report Page: 8 of 9 Time interval between beginning of rug aministration an start of reaction/event Time interval between last ose of rug an start of reaction/event 4 Day 3 Day Action(s) taken with rug Aitional information on rug Di reaction reappear after reintrouction? Cululative ose number (to first reaction) C: Structure of separate osages D: Number of separate osages Active rug substance name zopiclone 23. Other relevant history (... continuation...) Reactions, Symptoms an Events En Continuing Comments [ MeDRA 20.1 ( ): Rhinitis allergic ] Unknown [ MeDRA 20.1 ( ): Hypertension arterial ] Unknown Neu (im Rahmen er GBS-Diagnostik) festgestellte un meikamentös behanelte Arterielle Hypertonie. [ MeDRA 20.1 ( ): Retinopathy ] Unknown Ophtalmologische Behanlung bei Retinopathie. [ MeDRA 20.1 ( ): Guillain-Barre synrome ] OCT- Unknown Reziiv eines GBS Report uplicates Duplicate source DCGMA Duplicate number DE-DCGMA DE-DCGMA Patient past rug therapy Name of rug as reporte Inication MeDRA coe Reactions MeDRA coe En ivig [ MeDRA 20.1 (0): unbekannt ] [ MeDRA 20.1 (0): unbekannt ] 02-OCT- 06-OCT- Parent Parent ientification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant meical history an concurrent conitions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1
9 21-NOV- Report Page: 9 of 9 Ientification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Aitional ocuments Yes 1108 No List of ocuments hel by sener Does this case fulfill the local criteria for an expeite report? Yes Regulatory authority's case report number Other case ientifiers in previous transmissions Yes Was the case meically confirme, if not initially from health professional? Yes Primary source(s) of information Reporter postcoe Reporter country Qualification Literature reference(s) Stuy name Sponsor stuy number Stuy type in which the reaction(s)/event(s) were observe 69 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street aress City Berlin Postcoe Country Fax +49 / (0) / Telephone +49 / (0) / aress phv@akae.e PATIENT INFORMATION (... continuation...) Investigation number Gestation perio Patient age group Ault >18.Lj. bis einschl. 65.Lj. Weight (kg) 77 Height (cm) 170 Last menstrual perioe Text for relevant meical history an concurrent conitions Ansonsten anamnestisch keine Vorerkrankungen, un bis zur Krankenhauseinweisung auch keine meikamentöse Vorbehanlung.
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SUSPECT ADVERSE REACTION REPORT
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