CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17077431 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 84 DA MO YR (Year) Female 26 02 2017 bei Mischintoxikation (10010071): Coma ] bei Mischintoxikation (10006102): Bradypnoea ] (10013714): Drug intoxication ] (10068557): Suicidal intention ] Phenprocoumon Überdosierung in suizidaler Absicht (10068719): Drug overdose ] disseminierte Hautblutungen (10064266): Skin hemorrhage ] (10002034): Anaemia ] (10001041): Acute renal failure ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenenden Die Patientin nahm als Komedikation Dibenzazepine ein. Verlauf der Therapie der UAW: Herz-/Kreislauf instabil Arterenolperfusor, präklinische Intubation-Extubation am 27.02.2017, 4 Beutel Erythrozytenkonzentrat am 26.02.2017, II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) phenprocoumon 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "nach INR" Oral 17. INDICATION(S) FOR USE Paroxysmal atrial fibrillation DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION (cont.) þ 20. 21. 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 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) opipramol unbekannt (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.1 (10034039): Paroxysmal atrial fibrillation ] Continuing: Unknown [ MedDRA 19.1 (10012402): Depressive episode ] Continuing: Unknown [ MedDRA 19.1 (10003555): Asthma bronchial ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 01-MAR-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17077431 24d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 8 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Prothrombinkonzentrat am 26.02.2017 Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End bei Mischintoxikation [MedDRA 19.1 PT (10010071): Coma ] (10010071): Coma ] bei Mischintoxikation [MedDRA 19.1 PT (10006102): Bradypnoea ] (10006102): Bradypnoea ] [MedDRA 19.1 PT (10070863): Toxicity to various agents ] (10013714): Drug intoxication ] [MedDRA 19.1 PT (10042458): Suicidal ideation ] (10068557): Suicidal intention ] Phenprocoumon Überdosierung in suizidaler Absicht [MedDRA 19.1 PT (10033295): Overdose ] (10068719): Drug overdose ] disseminierte Hautblutungen [MedDRA 19.1 PT (10064265): Skin haemorrhage ] (10064266): Skin hemorrhage ] [MedDRA 19.1 PT (10002034): Anaemia ] (10002034): Anaemia ] [MedDRA 19.1 PT (10069339): Acute kidney injury ] (10001041): Acute renal failure ] * 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
Report Page: 3 of 8 INR >10 NA Haemoglobin 5.4 g/dl Creatinine 2.07 mg/dl Urea 32 mg/dl Uric acid 9.6 mg/dl 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) phenprocoumon A: nach INR B: C: D: E: Oral Paroxysmal atrial fibrillation 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 phenprocoumon Causality assessment Reaction Source Method Result [ MedDRA 19.1 (10001041): Acute renal failure ] [ MedDRA 19.1 (10002034): Anaemia ] [ MedDRA 19.1 (10006102): Bradypnoea ] [ MedDRA 19.1 (10010071): Coma ]
Report Page: 4 of 8 [ MedDRA 19.1 (10013714): Drug intoxication ] [ MedDRA 19.1 (10064266): Skin hemorrhage ] [ MedDRA 19.1 (10068557): Suicidal intention ] [ MedDRA 19.1 (10068719): Drug overdose ] 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) citalopram A: Dosierung unbekannt B: C: D: E: Oral Depression 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 citalopram Causality assessment Reaction Source Method Result [ MedDRA 19.1 (10001041): Acute renal failure ] [ MedDRA 19.1 (10002034): Anaemia ] [ MedDRA 19.1 (10006102): Bradypnoea ] [ MedDRA 19.1 (10010071):
Report Page: 5 of 8 Coma ] [ MedDRA 19.1 (10013714): Drug intoxication ] [ MedDRA 19.1 (10064266): Skin hemorrhage ] [ MedDRA 19.1 (10068557): Suicidal intention ] [ MedDRA 19.1 (10068719): Drug overdose ] 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) mirtazapin A: B: C: 30Mg milligram(s) D: E: 1Day Oral Depression 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 mirtazapine Causality assessment Reaction Source Method Result [ MedDRA 19.1 (10001041): Acute renal failure ] [ MedDRA 19.1 (10002034): Anaemia ] [ MedDRA 19.1 (10006102):
Report Page: 6 of 8 Bradypnoea ] [ MedDRA 19.1 (10010071): Coma ] [ MedDRA 19.1 (10013714): Drug intoxication ] [ MedDRA 19.1 (10064266): Skin hemorrhage ] [ MedDRA 19.1 (10068557): Suicidal intention ] [ MedDRA 19.1 (10068719): Drug overdose ] 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) opipramol A: unbekannt B: C: D: E: Depression 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 opipramol 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.1 (10034039): Paroxysmal atrial fibrillation ] Unknown [ MedDRA 19.1 (10012402): Depressive episode ] Unknown schwere depressive Episode [ MedDRA 19.1 (10003555): Asthma bronchial ] Unknown
Report Page: 7 of 8 [ MedDRA 19.1 (10066589): Recurrent depressive disorder ] Unknown rezidivierende depressive Störung [ MedDRA 19.1 (10059243): Latent hyperthyroidism ] Unknown 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 Yes 20170301 No List of documents held by sender Does this case fulfill the local criteria for an expedited report? Yes Regulatory authority's case report number Other case identifiers in previous transmissions Yes Was the case medically confirmed, if not initially from health professional? No Primary source(s) of information postcode country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 55 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period
Report Page: 8 of 8 Patient age group Elderly >65.Lj. Weight (kg) 60 Height (cm) 165 Last menstrual periode Text for relevant medical history and concurrent conditions