CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16306260 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy polyneuropathische Schmerzen an Armen und Beinen; Nervenbiopsie: Small fiber Neuropathie [ MedDRA 19.0 LLT (10073937): Results of tests and procedures relevant to the investigation of the patient: NLG-Untersuchung; MEP-Untersuchung 28.07.2016: Werte Basalurin vor und nach Mobilisierung mit Zn-DTPA von 2.255 mcg/g Kreatinin 18.08.2016: 24-h-Urin Reporter's comments: DA MO YR 38 DA MO YR (Year) Female 11 2015 Sonstiges: Wichtrig ist die Vielzahl von MRT-Untersuchungen, die seit 1999 gemacht wurden. Dadurch entstand eine Kumulation des Gadoliniums, die man in mehreren Urinuntersuchungen nachweisen konnte. Gadolinium kann also zur Retention führen, was bei wiederholten kontrastmittelhaltigen Untersuchungen strenger gehandhabt werden sollte. 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) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 06-MAY-1999 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) (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 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 25-AUG-2016 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16306260 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 12 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Maßnahmen: Therapie mit Chelatbildner Zn-DTPA, Antientzündliche Maßnahmen, schmerzmittelresistent(nsar, Novalgin), nur Lyrica 75 mg hilft ein wenig Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** polyneuropathische Schmerzen an Armen und Beinen; Nervenbiopsie: Small fiber Neuropathie [MedDRA 19.0 PT (10073928): Small fibre neuropathy ] not recovered/not resolved NOV-2015 [ MedDRA 19.0 LLT (10073937): Small fiber neuropathy ] * 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 17-JUN-2016 Neurological examination vorhanden/present NA 28-JUL-2016 Drug level 0.772 mcg/g Kreatini <0.230 28-JUL-2016 Drug level 2.255 mcg/g Kreatini <0.230 18-AUG-2016 Drug level 0.943 mcg/g Kreatini <0.230 06-MAY- 1999 C: 16 Year Drug: Omniscan or Magnevist; unknown dose * Dosage Text
Report Page: 3 of 12 Cumulative dose number (to first reaction) Number of separate dosages 06-OCT- 2000 C: 15 Year Drug: Omniscan or Magnevist; unknown dose * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages
Report Page: 4 of 12 06-JUL- 2001 C: 14 Year Drug: Omniscan or Magnevist; unknown dose * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages magnevist 03-NOV- 2009 C: 12ml millilitre(s)
Report Page: 5 of 12 5 Year * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadopentetate dimeglumine magnevist 11-AUG- 2010 C: 11ml millilitre(s) 5 Year * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages
Report Page: 6 of 12 gadopentetate dimeglumine magnevist 16-JUL- 2012 C: 15ml millilitre(s) 3 Year * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadopentetate dimeglumine gadovist 21-DEC- 2012 C: 7.5ml millilitre(s)
Report Page: 7 of 12 2 Year * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadobutrol dotarem 08-NOV- 2013 C: 10ml millilitre(s) 1 Year
Report Page: 8 of 12 * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadoterate meglumin dotarem 25-FEB- 2015 C: 15ml millilitre(s) 8 Month * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadoterate meglumin
Report Page: 9 of 12 gadovist 30-MAR- 2015 C: 9ml millilitre(s) 7 Month * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadobutrol dotarem 05-AUG- 2015 C: 10ml millilitre(s)
Report Page: 10 of 12 89 Day * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadoterate meglumin dotarem 05-OCT- 2015 C: 15ml millilitre(s) 28 Day
Report Page: 11 of 12 * Dosage Text Cumulative dose number (to first reaction) Number of separate dosages gadoterate meglumin Report duplicates Duplicate source Duplicate number DE-DCGMA-16170779 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 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? Yes 20160825 Yes Laboratory findings Yes Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? Yes 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 63 Physician
Report Page: 12 of 12 SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode 10623 Country Fax +49 / (0)30 4004 / 56555 Telephone +49 / (0)30 4004 / 56500 E-mail address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 68 Height (cm) 168 Last menstrual periode Text for relevant medical history and concurrent conditions