SUSPECT ADVERSE REACTION REPORT
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- Jeremy Waters
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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 69 DA MO YR (Year) Male dauerhaftes Nasenbluten [ MedDRA 19.1 LLT ( ): se bleed ] blutiger Husten [ MedDRA 19.1 LLT ( ): Coughing blood ] Beschwerden mit der Sehfähigkeit des rechten Auges [ MedDRA 19.1 LLT ( ): Sight disability ] 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Ich habe den Blutverdünner auf Empfehlung der Klinik XY verwendet. Es sind nach einem Tag sofort Beschwerden, wie dauerhaftes Nasenbluten und blutiger Husten aufgetreten. Nach zwei Tagen hatte ich Beschwerden mit der Sehfähigkeit des rechten Auges. Ich habe die Medikamente vor einem Monat wieder abgesetzt, das Nasenbluten ist erst nach drei Tagen danach verschwunden, die Behinderung der Sehfähigkeit bisher noch nicht. INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (include generic name) eliquis II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 2 Df dosage form every Day" [ 2 Df dosage form { 1 Df dosage form, 2 in 1 Day } ] 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 01-JAN-2017 to 03-JAN Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) lanicor 0.25 mg daily dose: 0.25 Mg milligram(s) every Day pantozol 20 mg daily dose: 20 Mg milligram(s) every Day (cont.) DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.1 ( ): Atrial fibrillation ] Continuing: Yes (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 07-FEB-2017 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 Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Beschwerden mit der Sehfähigkeit des rechten Auges [MedDRA 19.1 PT ( ): Sight disability ] not recovered/not resolved 5 Day [ MedDRA 19.1 LLT ( ): Sight disability ] dauerhaftes Nasenbluten [MedDRA 19.1 PT ( ): Epistaxis ] [ MedDRA 19.1 LLT ( ): se bleed ] blutiger Husten [MedDRA 19.1 PT ( ): Haemoptysis ] [ MedDRA 19.1 LLT ( ): Coughing blood ] 4 Day recovered/resolved 1 Day 3 Day 4 Day recovered/resolved 1 Day 3 Day 01-JAN JAN-2017 * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** 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 Duration Dose * Route(s) of eliquis 01-JAN JAN Day A: daily dose: 2 Df dosage form every Day B: 2Df dosage form C: 1Df dosage form D: 2 Bristol-Myers Squibb Drug withdrawn
3 Report Page: 3 of 6 B: Cumulative dose number (to first reaction) C: Structure dosages number apixaban 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of lanicor 0.25 mg A: daily dose: 0.25 Mg milligram(s) every Day B: C: 0.25Mg milligram(s) D: 1 seit Jahren B: Cululative dose number (to first reaction) C: Structure of separate dosages digoxin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of pantozol 20 mg A: daily dose: 20 Mg milligram(s) every Day B: C: 20Mg milligram(s) D: 1
4 Report Page: 4 of 6 seit Jahren B: Cululative dose number (to first reaction) C: Structure of separate dosages pantoprazole sodium 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of kalium-magnesium 400 A: daily dose: 0.5 Df dosage form every Day B: C: 0.5Df dosage form D: 1 seit Jahren
5 Report Page: 5 of 6 B: Cululative dose number (to first reaction) C: Structure of separate dosages potassium adipate magnesium adipate 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 19.1 ( ): Atrial fibrillation ] Yes permanentes Vorhofflimmern Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code ass 100 [ MedDRA 19.1 (0): unbekannt ] [ MedDRA 19.1 (0): unbekannt ] DEC ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 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? 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 Regulatory Authority
6 Report Page: 6 of 6 Department Street address City Bonn Postcode Country Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 80 Height (cm) 186 Last menstrual periode Text for relevant medical history and concurrent conditions
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