CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17134359 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 (10024574): increased ] (10033645): Pancreatitis ] (10069826): Inflammatory marker increased ] 16 DA MO YR (Month) Male 04 01 2017 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION Results of tests and procedures relevant to the investigation of the patient: Sonographische Untersuchung zeigte Pankreas regelrecht, ohne Umgebungsreaktion; Reporter's comments: Verlauf: Stationäre Aufnahme aufgrund geplanter PEG-Anlage bei Ernährungsschwierigkeiten. Im Rahmen laborchemischer Routinekontrollen zeigten sich deutlich erhöhte Entzündungs- und werte als Zeichen einer Pankreatitis. Verschiebung der PEG-Anlage, beenden antikonvulsiver Therapie mit Valproat, Beginn Phenobarbital, Anpassung Analgesie, i. v. Flüssigkeitssubstitution, pankreasschonende Kost, II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) valproat 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 480 Mg millgram(s) every Days" { 240 Mg Oral milligram(s), 2 in } 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION to III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) zebinix to daily dose: 400 Mg millgram(s) every Days 20. 21. 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.) [ MedDRA 19.1 (10048911): Lissencephaly ] Continuing: [ MedDRA 19.1 (10048910): Pachygyria ] Continuing: [ MedDRA 19.1 (10023611): Lack of expected normal physiological development ] Continuing: IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 06-APR-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17134359 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 5 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) daraufhin rückläufige Werte, Entlassung in gutem Allgemeinzustand; Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End [MedDRA 19.1 PT (10024574): increased ] (10024574): increased ] [MedDRA 19.1 PT (10033645): Pancreatitis ] (10033645): Pancreatitis ] [MedDRA 19.1 PT (10069826): Inflammatory marker increased ] (10069826): Inflammatory marker increased ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit Normal low range Normal high range More inform. available 2.507 C-reactive protein 34.7 mg/l 05-JAN-2017 2.300 08-JAN-2017 217 Ultrasound abdomen vorhanden/present NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) valproat 04-JAN- 2017 A: daily dose: 480 Mg millgram(s) every Days B: C: 240Mg milligram(s) D: 2 E: 1Day Oral Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form)
Report Page: 3 of 5 Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name valproate sodium 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) zebinix 04-JAN- 2017 A: daily dose: 400 Mg millgram(s) every Days B: C: 200Mg milligram(s) D: 2 E: 1Day Oral Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name
Report Page: 4 of 5 eslicarbazepine acetate Causality assessment Reaction Source Method Result [ MedDRA 19.1 (10024574): increased ] [ MedDRA 19.1 (10033645): Pancreatitis ] [ MedDRA 19.1 (10069826): Inflammatory marker increased ] 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.1 (10048911): Lissencephaly ] [ MedDRA 19.1 (10048910): Pachygyria ] [ MedDRA 19.1 (10023611): Lack of expected normal physiological development ] [ MedDRA 19.1 (10054016): General nutrition disorder ] Ernährungspropbleme (ICD: R63.3, Z53) Report duplicates Duplicate source Duplicate number DE-DCGMA-17173328 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 Identification of the country 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? 20170406 medical report Regulatory authority's case report number Other case identifiers in previous transmissions
Report Page: 5 of 5 Was the case medically confirmed, if not initially from health professional? 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 91 Physician 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 Infant 29 Tage bis einschl. 3.Lj. Weight (kg) 7.1 Height (cm) 74 Last menstrual periode Text for relevant medical history and concurrent conditions