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 61 DA MO YR (Year) Male 04 gelegentliches Nasenbluten ( ): se bleed ] anhaltende starke Schmerzen/Brennen in der Harnröhre ( ): Pain urethral ] ( ): Anal hemorrhage ] ( ): Urogenital haemorrhage ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Mein Ehemann wurde aufgrund eines schweren nächtlichen Harnverhaltes am an der Prostata operiert. Die OP verlief komplikationslos. Am 4.4. entsand postoperativ eine Lungenembolie, die in der Klinik behandelt wurde. Nach der Entlassung aus der Klinik erhielt mein Mann die Medikation Xarelto. Nach 3 Wochen wurde die Dosis auf 2x täglich 20 mg reduziert. Von Beginn der Medikation an traten starke Blutungen im Analbereich sowie im Urogenitalbereich und gelegentlich aus der Nase auf begleitet von anhaltenden starken Schmerzen/Brennen in der Harnröhre. Die Schmerzen bzw. das Brennen beginnen sehr unmittelbar nach der Einnahme von Xarelto. Das Brennen in der Harnröhre wird als überaus beeinträchtigend empfunden CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED 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.) xarelto 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 3 Week 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 ( ): Urinary hesitation ] Continuing: [ MedDRA 19.0 ( ): Prostate surgery ] from 29-MAR- Continuing: [ MedDRA 19.0 ( ): Prostate surgery ] from 29-MAR- Continuing: (cont.) 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...) Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** Start End [MedDRA 19.0 PT ( ): Anal haemorrhage ] ( ): Anal hemorrhage ] [MedDRA 19.0 PT ( ): Urogenital haemorrhage ] ( ): Urogenital haemorrhage ] gelegentliches Nasenbluten [MedDRA 19.0 PT ( ): Epistaxis ] ( ): se bleed ] anhaltende starke Schmerzen/Brennen in der Harnröhre [MedDRA 19.0 PT ( ): Urethral pain ] ( ): Pain urethral ] * 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 Dose * Route(s) of Administration Indication(s) xarelto APR- 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 3 Week A: B: C: D: E:

3 Report Page: 3 of 5 Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Dose reduced 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 rivaroxaban 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) xarelto A: daily dose: 40 Mg milligram(s) every Day B: C: 20Mg milligram(s) D: 2 E: 1Day 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) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name rivaroxaban 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.0 ( ): Urinary hesitation ] nächtlicher Harnverhalt

4 [ MedDRA 19.0 ( ): Prostate surgery ] 29-MAR- [ MedDRA 19.0 ( ): Pulmonary embolism ] 04-APR- Report Page: 4 of 5 komplikationslose Prostata-OP postoperative Lungenembolie 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 0506 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? 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 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number

5 Report Page: 5 of 5 Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions