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 Eosinophilie unter Leponex [ MedDRA 19.0 LLT ( ): Reporter's comments: DE DA MO YR DA MO YR Verlauf: UAW abgeklungen, klinisch asymptomatisch; Absetzen von Leponex, Solian 300 mg statt Leponex. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED Male þ 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) (cont.) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "12.5 mg/d bis 125 mg/d" Oral 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 18-JUN- to 13-JUL- 26 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 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 19.0 ( ): Paranoid schizophrenia ] Continuing: Unknown [ MedDRA 19.0 ( ): Paranoid schizophrenia ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 29-JUN-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 Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Eosinophilie unter Leponex [MedDRA 19.0 PT ( ): recovered/resolved [ MedDRA 19.0 LLT ( ): * 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 14-JUL- Eosinophil count 2976 /nl 20-JUN- Eosinophils JUL- Eosinophils JUL- Eosinophils JUL- Eosinophils Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) 18-JUN- 13-JUL- 26 Day A: 12.5 mg/d bis 125 mg/d B: C: D: E: 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: Cumulative dose number (to first reaction)

3 Report Page: 3 of 5 C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name clozapine Causality assessment Reaction Source Method Result [ MedDRA 19.0 ( ): AGATE probable/likely 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) 14-JUL- A: B: C: 100Mg milligram(s) D: 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 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 clozapine Causality assessment Reaction Source Method Result [ MedDRA 19.0 ( ): AGATE probable/likely 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments

4 Report Page: 4 of 5 [ MedDRA 19.0 ( ): Paranoid schizophrenia ] Unknown Report duplicates Duplicate source Institut AGATE ggmbh Duplicate number MK 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 No 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? 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 94 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...)

5 Report Page: 5 of 5 Investigation number Gestation period Patient age group Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions