SUSPECT ADVERSE REACTION REPORT

Transcription

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 seit ca. 6 Monaten zunehmende Fremdaggression gegen Freunde,Lehrer,Familienangehörige,keine Autoaggression [ MedDRA 19.1 LLT ( ): Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Verlauf der Therapie der unerwünschten Arzneimittelwirkung: Kinderpsychiatrische Diagnostik und Therapie wurde erst begonnen DA MO YR 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED Male 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) kuvan 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 400 Mg milligram(s),1 Day 17. INDICATION(S) FOR USE Phenylalaninemia 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 2012 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) centrum a bis z from JUN 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 19.1 ( ): Phenylalaninemia ] Continuing: Unknown [ MedDRA 19.1 ( ): Low protein therapeutic diet ] Continuing: Unknown 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 15-NOV-2016 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...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** seit ca. 6 Monaten zunehmende Fremdaggression gegen Freunde,Lehrer,Familienangehörige,keine Autoaggression [MedDRA 19.1 PT ( ): [ MedDRA 19.1 LLT ( ): not recovered/not resolved * 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 rmal low range rmal high range More inform. available Phenylalanine screen normal/normal NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of kuvan 2012 A: C: 400Mg milligram(s) D: Phenylalaninemia Bionorica Cumulative dose number (to first reaction) C: Structure dosages number sapropterin hydrochloride

3 Report Page: 3 of 5 Causality assessment Reaction Source Method Result [ MedDRA 19.1 ( ): Primarysource Global Introspection (WHO GI) probable/likely 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of centrum a bis z JUN A: C: 1Df dosage form D: Vitamin deficiency Indikation:Vitaminmangel bei Diät Cululative dose number (to first reaction) C: Structure of separate dosages vitamins nos minerals nos 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of ferro sanol FEB A: daily dose: 40 Mg milligram(s) every Day C: 40Mg milligram(s) D: 1 Iron deficiency

4 Report Page: 4 of 5 Indikation:Eisenmangel bei Diät Cululative dose number (to first reaction) C: Structure of separate dosages ferroglycine sulfate complex 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 19.1 ( ): Phenylalaninemia ] Unknown Hyperphenylalaninämie mit gelockerter Eiweißparameter Diät [ MedDRA 19.1 ( ): Low protein therapeutic diet ] Unknown 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 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?

5 Report Page: 5 of 5 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 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Weight (kg) 20.7 Height (cm) 155 Last menstrual periode Text for relevant medical history and concurrent conditions