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 ( ): Constipation ] ( ): Bone pain ] Schulter,Ellbogen,Hüft,Finger,Zehen ( ): Joint pain ] ( ): Elevated liver enzymes ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DA MO YR DA MO YR Nach der Brustkrebsdiagnose wurde bei mir beidseitig die Brust entfernt (Mastektomie) und zur Vorbeugung eine Antihormontherapie mit Letrozol (2 Jahre) und Tamoxifen (3 Jahre) empfohlen. Durch die Einnahme von Letrozol bekam ich nach 3 Wochen Verstopfung (Obstipation), die sich im Verlauf der Therapie weiter verschlechterte. Die Empfehlung der behandelnden Ärztinnen, vermehrt Buttermilch zu trinken und Backpflaumen zu essen, brachte keine Linderung. Etwa 4 Wochen nach Einnahme von Letrozol stellten sich massive Knochen- und Gelenkschmerzen (Arthralgie) in Schulter-, Ellbogen-, Knie-, Hüft-, Finger- und Zehengelenken ein. Als im Oktober auch noch eine Verschlechterung der Leberwerte (Erhöhung der Leberenzymwerte) eintrat, habe ich Letrozol abgesetzt und bin nicht dem Rat der Nachsorgeärztin gefolgt, nun ein II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) letrozol 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE DE 72 (Year) Female 18. THERAPY DATES (from/to) 19. THERAPY DURATION 2 Year III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) tamoxifen 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.) [ MedDRA 19.1 ( ): Mastectomy ] Continuing: [ MedDRA 19.1 ( ): Breast cancer ] Continuing: [ MedDRA 19.1 ( ): Breast cancer ] Continuing: 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE 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...) Medikament gegen Verstopfung, ein Medikament gegen Knochen- und Gelenkschmerzen und ein Medikament gegen die verschlechterten Leberwerte einzunehmen. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End [MedDRA 19.1 PT ( ): Constipation ] 3 Week ( ): Constipation ] [MedDRA 19.1 PT ( ): Bone pain ] 4 Week ( ): Bone pain ] Schulter,Ellbogen,Hüft,Finger,Zehen [MedDRA 19.1 PT ( ): Arthralgia ] ( ): Joint pain ] 4 Week [MedDRA 19.1 PT ( ): Hepatic enzyme increased ] ( ): Elevated liver enzymes ] * 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) letrozol 2 Year A: B: C: D: E: 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

3 Report Page: 3 of 5 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 letrozole 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) tamoxifen 3 Year A: B: C: D: E: 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 tamoxifen 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.1 ( ): Mastectomy ]

4 Report Page: 4 of 5 [ MedDRA 19.1 ( ): Breast cancer ] Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM 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 Deutschland 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? DE-CADRBFARM 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 Deutschland Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Deutschland

5 Report Page: 5 of 5 Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 65 Height (cm) 174 Last menstrual periode Text for relevant medical history and concurrent conditions