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 Female Kniegelenkserguss [ MedDRA 19.0 LLT ( ): Effusion of lower leg joint ] Bakerzyste re. Knie [ MedDRA 19.0 LLT ( ): Baker's cyst ] DA MO YR 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED 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) exemestan 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 25 Mg millgram(s) every Days" { 25 Mg Oral milligram(s), 1 in 1 Day } 17. INDICATION(S) FOR USE Adjuvant therapy 18. THERAPY DATES (from/to) 19. THERAPY DURATION from NOV-2015 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) enalapril from OCT-2014 daily dose: 5 Mg millgram(s) every Days 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 ( ): Breast cancer ] from JUL-2013 Continuing: Unknown [ MedDRA 19.0 ( ): Breast cancer ] from JUL-2013 Continuing: Unknown [ MedDRA 19.0 ( ): Lymphoedema ] Continuing: Unknown IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 05-SEP-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*** Start End Kniegelenkserguss [MedDRA 19.0 PT ( ): Joint effusion ] not recovered/not resolved [ MedDRA 19.0 LLT ( ): Effusion of lower leg joint ] Bakerzyste re. Knie [MedDRA 19.0 PT ( ): Synovial cyst ] not recovered/not resolved [ MedDRA 19.0 LLT ( ): Baker's cyst ] * 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 rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) exemestan NOV A: daily dose: 25 Mg millgram(s) every Days B: C: 25Mg milligram(s) D: 1 E: 1Day Oral Adjuvant therapy 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 Dose not changed Indikation: adjuvante ET bei Mamma Ca. Did reaction reappear after reintroduction?

3 Report Page: 3 of 5 * 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 exemestane Causality assessment Reaction Source Method Result [ MedDRA 19.0 ( ): Effusion of lower leg joint ] AkdÄ Global Introspection (WHO GI) possible [ MedDRA 19.0 ( ): Baker's cyst ] AkdÄ Global Introspection (WHO GI) possible 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) enalapril OCT A: daily dose: 5 Mg millgram(s) every Days B: C: 5Mg milligram(s) D: 1 E: 1Day Oral Hypertension 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 Dose not changed 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 enalapril 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments

4 [ MedDRA 19.0 ( ): Breast cancer ] JUL Unknown Report Page: 4 of 5 ICD C50.9 L [ MedDRA 19.0 ( ): Lymphoedema ] Unknown ICD I89.0 L Report duplicates Duplicate source Duplicate number DE-DCGMA 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? 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 33 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode 10623

5 Report Page: 5 of 5 Country Fax +49 / (0) / Telephone +49 / (0) / address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Weight (kg) 66.2 Height (cm) 166 Last menstrual periode Text for relevant medical history and concurrent conditions