CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17174559 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 60 DA MO YR (Year) Female 04 11 2016 [ MedDRA 20.0 LLT (10011703): Cyanosis ] [ MedDRA 20.0 LLT (10050400): Vigilance decreased ] CO2-Narkose (Coma hyperkapnicum) [ MedDRA 20.0 LLT (10010071): Coma ] [ MedDRA 20.0 LLT (10069144): Acute respiratory insufficiency ] 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Symptomatik: Patientin wurde aufgrund einer Angsterkrankung am 4.11.2016 aufgenommen, hatte kurz zuvor (ca. 30 min vor Eintreten der UAW) 1mg Lorazepam zuhause eingenommen. Bei Aufnahme rasche Zyanose mit Vigilanzabfall bis hin zum Koma aufgrund C02-Narkose, Verlegung auf die Intensivstation im Hause mit Intubation, darunter rasche Besserung. Extubation am 4.11.2016 erfolgt, Inhalation mit Prednisolon, am 7.11.2016; Rückverlegung in die psychiatrische Abteilung. Diagnose: resp. Insuffizienz bei exazerbierter COPD ohne laborchemischen/röntgenolog. Anhalt für Infekt. Begründung des Wahrscheinlichkeitsgrads: Zeitlicher Zusammenhang zwischen Tavoreinnahme 14. SUSPECT DRUG(S) (include generic name) tavor II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 1 Mg 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 2015 to 04-NOV-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) remergil from 2014 to 04-NOV-2016 remergil from 2014 to 04-NOV-2016 (cont.) þ 20. 21. 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 (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10018075): Generalised anxiety disorder ] Continuing: Unknown [ MedDRA 20.0 (10010952): COPD ] Continuing: Yes (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 02-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17174559 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 11 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) und UAW-Beginn lässt eine Kausalität als möglich annehmen, daher W1, aber COPD Gold V vorbeschrieben. Unter Citalopram und Amlodipin sind gelegentliche Atemnot sowie unter L-Thyroxin Dyspnoe ohne Häufigkeitsangabe bekannt, die Medikation wurde aber nicht kürzlich verändert, daher W0. Maßnahmen nach der UAW: Absetzen; Verlegung; medikamentöse Gegenmaßnahmen; Absetzen von Lorazepam; Verlegung: ITS im Hause; Med. Gegenmaßnahmen: Prednisolon inhalativ; Nicht-med. Gegenmaßnahmen: Intubation mit Beatmung; Diagnostik: Röntgen Thorax: siehe Beschreibung UAW Verlauf: UAW abgeklungen Weiterbehandlung: Am 7.11.2016 Übernahme auf psychiatrische Normalstation. Seit 11.11.2016 Mirtazapin 15mg 0-0-0-1, bisher ohne UAW und bei gebessertem Schlaf. Mögliche Risikoaktoren: ja; Vorschädigung des betroffenen Organs schwere bekannte COPD; Infektexazerbation vermutet, wurde aber laborchemisch und röntgenologisch nicht bestätigt Results of tests and procedures relevant to the investigation of the patient: ph-wert: Norm: 7,37-7,45 4.11.2016 7,123 7.11.2016 7,388 Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT (10001053): Acute respiratory failure ] [ MedDRA 20.0 LLT (10069144): Acute respiratory insufficiency ] 4 Day recovered/resolved 30 Minute 1 Day 04-NOV-2016 07-NOV-2016 [MedDRA 20.0 PT (10011703): Cyanosis ] [ MedDRA 20.0 LLT (10011703): Cyanosis ] 4 Day recovered/resolved 30 Minute 1 Day 04-NOV-2016 07-NOV-2016 [MedDRA 20.0 PT (10013496): Disturbance in attention ] [ MedDRA 20.0 LLT (10050400): Vigilance decreased ] 4 Day recovered/resolved 30 Hour 1 Day 04-NOV-2016 07-NOV-2016 CO2-Narkose (Coma hyperkapnicum) [MedDRA 20.0 PT (10010071): Coma ] [ MedDRA 20.0 LLT (10010071): Coma ] 4 Day recovered/resolved 30 Minute 1 Day * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** and start of reaction/event 04-NOV-2016 07-NOV-2016 Results of tests Date Test Result Unit Normal low range Normal high range More inform. available 04-NOV-2016 Partial pressure CO2 125 mmhg 35 45 07-NOV-2016 Partial pressure CO2 79,3 mmhg 35 45 04-NOV-2016 Base excess 11,7 mmol/l -2 +3
Report Page: 3 of 11 07-NOV-2016 Base excess 22,7 mmol/l -2 +3 04-NOV-2016 Gamma GT 82,2 U/L <38,1 08-NOV-2016 Gamma GT 87,0 U/L <38,1 08-NOV-2016 SGOT 33,6 U/L <31,0 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of tavor 2015 04-NOV- 2016 A: C: 1Mg E: Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number lorazepam Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10069144): Acute respiratory insufficiency ] AMSP Global Introspection (WHO GI) possible [ MedDRA 20.0 (10011703): Cyanosis ] AMSP Global Introspection (WHO GI) possible [ MedDRA 20.0 (10050400): Vigilance decreased ] AMSP Global Introspection (WHO GI) possible [ MedDRA 20.0 (10010071): Coma ] AMSP Global Introspection (WHO GI) possible 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...)
Report Page: 4 of 11 remergil 2014 04-NOV- 2016 Cululative dose number (to first reaction) Dose reduced A: C: 30Mg mirtazapine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) remergil 11-NOV- 2016 A: C: 15Mg
Report Page: 5 of 11 Cululative dose number (to first reaction) mirtazapine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) citalopram 2014 04-NOV- 2016 Cululative dose number (to first reaction) A: C: 30Mg citalopram 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) pantoprazol 2010 A: C: 40Mg
Report Page: 6 of 11 Magen-Darm-Mittel Cululative dose number (to first reaction) pantoprazole 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) aspirin 2010 A: C: 100Mg Analgesic therapy Analgetika/Antirheumatika
Report Page: 7 of 11 Cululative dose number (to first reaction) acetylsalicylic acid 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) l-thyroxin 2006 A: C: 75µg microgram(s) Thyroid disorder Cululative dose number (to first reaction) levothyroxine sodium 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) amlodipin 2010 A: C: 5Mg
Report Page: 8 of 11 Beta-Bl., Ca.-Ag., ACE-H. Cululative dose number (to first reaction) amlodipine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) valsartan 2010 A: C: 80Mg Hypertension Cululative dose number (to first reaction) valsartan 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) Duration Dose *
Report Page: 9 of 11 Route(s) of salbutamol 1995 A: C: 0.1Mg Broncholytika/Antiasthm. Cululative dose number (to first reaction) salbutamol 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) ultibro 2014 A: 43/85 µg/d C: E:
Report Page: 10 of 11 Broncholytika/Antiasthm. Cululative dose number (to first reaction) glycopyrronium bromide indacaterol maleate 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10018075): Generalised anxiety disorder ] Unknown Generalisierte Angststörung [ MedDRA 20.0 (10010952): COPD ] Yes Chronische obstruktive Lungenkrankheit, COPD Gold V Report duplicates Duplicate source AMSP - Institut für Arzneimittelsicherheit in der Duplicate number bsk-07-002 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 Yes 20170502 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 Was the case medically confirmed, if not initially from health professional? Yes No 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 14 Physician
Report Page: 11 of 11 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 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