CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17182043 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 [ MedDRA 20.0 LLT (10001718): Allergic reaction ] 57 DA MO YR (Year) Male 31 08 2015 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Symptomatik: Der Pat. beklagte am 31.08. Juckreiz und Kribbeln. Er hatte diese Beschwerden bis zum 02.09.; dann wurde Bupropion abgesetzt. Es gab keinen Hautausschlag. Am 02.09. wurde er notfallmäßig mit Luftnot in ein somatisches Krankenhaus verlegt. Dort wurde die Luftnot auf psychogene Faktoren zurückgeführt. Begründung des Wahrscheinhichkeitsgrads: Alle Medikamente können theoretisch Juckreiz und allergische Reaktionen auslösen. Bupropion macht dies am häufigsten; des Weiteren war Bupropion das einzige Medikament, das kurz vor dein Auftreten der Symptome angesetzt worden war. Alle anderen Medik. bis auf Venlafaxin hatte der Pat. in unveränderter Dosierung seit vor dem Beginn der Behandlung. Frühere Exposition: nein Reexposition.: nein 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) 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 14. SUSPECT DRUG(S) (include generic name) bupropion II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 150 Mg,1 Day 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 20-AUG-2015 to 26-AUG-2015 7 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) azathioprin metformin to 27-JUL-2015 (cont.) 20. 21. 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 (10012399): Depressive disorder ] Continuing: Unknown [ MedDRA 20.0 (10009013): Chronic myeloid leukaemia ] Continuing: Unknown [ MedDRA 20.0 (10045242): Type II diabetes mellitus ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 30625 Hannover, DE 24c. DATE RECEIVED BY MANUFACTURER 13-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17182043 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 10 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Maßnahmen nach der UAW: Absetzen; Verlegung; medikamentöse Gegenmaßnahmen Absetzen von Bupropion; Verlegung: somatisches KH: Die letzte Gabe der Medikation war am 02.09. Am diesem Tag wurde der Pat. mit Luftnot (aber nicht wegen des Juckreizes) in ein somatisches KH verlegt. Dort konnte keine Ursache gefunden werden. Die Ärzte sind von keiner allergischen Reaktion ausgegangen. Med. Gegenmaßnahmen: Cetirizin 10mg b.b. Verlauf: UAW abgeklungen Weiterbehandlung: Keine weiteren Maßnahmen waren erforderlich: Nach dem Absetzen der Medikation wurde kein weiteres Antidepressivum angeordnet. Der Pat wurde schon vor der Aufnahme mit Venlafaxin behandelt (s. auch Liste mit Medikation unten). Mögliche Risikofaktoren: ja; schnelle Dosissteigerung Alternativerklärungen: nein Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT (10020751): Hypersensitivity ] 3 Day recovered/resolved 31-AUG-2015 02-SEP-2015 [ MedDRA 20.0 LLT (10001718): Allergic reaction ] * 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 Normal low range Normal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of bupropion 20-AUG- 26-AUG- 7 Day A: 2015 2015 C: 150Mg 12 Day 6 Day
Report Page: 3 of 10 Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages bupropion Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10001718): Allergic reaction ] AMSP Global Introspection (WHO GI) probable/likely 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of bupropion 27-AUG- 02-SEP- 2015 2015 7 Day A: C: 300Mg 5 Day 3 Day Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages bupropion Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10001718): AMSP Global Introspection (WHO GI) probable/likely
Report Page: 4 of 10 Allergic reaction ] 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) azathioprin A: C: 150Mg Cululative dose number (to first reaction) Number of separate dosages azathioprine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) metformin 27-JUL- 2015 A: C: 1000Mg
Report Page: 5 of 10 Cululative dose number (to first reaction) Number of separate dosages metformin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) metformin 28-JUL- 2015 A: C: 1500Mg Cululative dose number (to first reaction) Number of separate dosages metformin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...)
Report Page: 6 of 10 januvia A: C: 100Mg Cululative dose number (to first reaction) Number of separate dosages sitagliptin phosphate 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) glivec A: C: 400Mg
Report Page: 7 of 10 Cululative dose number (to first reaction) Number of separate dosages imatinib 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) tamsulosin A: C: 0.4Mg Cululative dose number (to first reaction) Number of separate dosages tamsulosin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) venlafaxin 13-AUG- A:
Report Page: 8 of 10 2015 C: 150Mg Cululative dose number (to first reaction) Number of separate dosages venlafaxine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) venlafaxin 14-AUG- 2015 A: C: 300Mg
Report Page: 9 of 10 Cululative dose number (to first reaction) Number of separate dosages venlafaxine 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10012399): Depressive disorder ] Unknown Rezidivierende depressive Störung, gegenwärtig schwere Episode ohne psychotische Symptome [ MedDRA 20.0 (10009013): Chronic myeloid leukaemia ] Unknown [ MedDRA 20.0 (10045242): Type II diabetes mellitus ] Unknown [ MedDRA 20.0 (10009900): Colitis ulcerative ] Unknown [ MedDRA 20.0 (10013492): Distress respiratory ] Unknown Report duplicates Duplicate source der Duplicate number D-28-007 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 20170513 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
Report Page: 10 of 10 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 40 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Hannover Postcode 30625 Country Fax Telephone E-mail address 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