CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17060862 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 (10057363): Allergic exanthema ] (10046735): Urticaria ] (10037087): Pruritus ] (10014254): Edema Quincke's ] (10042700): Swelling of legs ] 49 DA MO YR (Year) Male 17 07 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Symptomatik: Auftreten eines Quincke-Ödems nach Einnahme von Aripiprazol, urtikarielles Exanthem, Juckreiz, Pusteln, Schwellung der Beine. Außer dem Ansetzen von Aripiprazol sonst keine medikamentöse Veränderungen. (Außer Reduktion von Risperidon und Diazepam.) Frühere Exposition: nein Reexposition: nein Maßnahmen nach der UAW: Absetzen Clemastin, Decortin, Fenistil oral und i.v.; Cetirizin Mögliche Risikofaktoren: nein; keine Allergien o.ä. bekannt 8-12 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) aripiprazol II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 15 Mg, 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 14-JUL- to 17-JUL- 4 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) quilonum retard from 22-JUN- to 23-JUL- quilonum retard from 22-JUN- to 23-JUL- (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 19.1 (10004908): Bipolar affective disorder ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 20-FEB-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17060862 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 7 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Alternativerklärungen: ja - eher wahrscheinlich Auch 6 Tage nach Absetzen von Aripiprazol Fortbestehen der Reaktion; nach Decortin und Clemastin-Gabe Remission. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 19.1 PT (10012434): Dermatitis allergic ] (10057363): Allergic exanthema ] 17-JUL- 23-JUL- [MedDRA 19.1 PT (10046735): Urticaria ] (10046735): Urticaria ] 17-JUL- 23-JUL- [MedDRA 19.1 PT (10037087): Pruritus ] (10037087): Pruritus ] 17-JUL- 23-JUL- [MedDRA 19.1 PT (10002424): Angioedema ] (10014254): Edema Quincke's ] 17-JUL- 23-JUL- [MedDRA 19.1 PT (10048959): Peripheral swelling ] (10042700): Swelling of legs ] 17-JUL- 23-JUL- * 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 21-JUL- Leucocyte count 12.89 /nl 21-JUL- Neutrophil percentage 90.9 rel 21-JUL- Eosinophil percentage 0.4 21-JUL- Blood lithium level 0.84 mmol/l 21-JUL- C-reactive protein 1.42 mg/l 21-JUL- Sodium 133 mmol/l 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of aripiprazol 14-JUL- 17-JUL- 4 Day A: C: 15Mg
Report Page: 3 of 7 4 Day Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number aripiprazole Causality assessment Reaction Source Method Result [ MedDRA 19.1 (10057363): Allergic exanthema ] AGATE Global Introspection (WHO GI) probable/likely 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) quilonum retard 22-JUN- 23-JUL- 32 Day A: C: 1800Mg
Report Page: 4 of 7 Cululative dose number (to first reaction) lithium carbonate 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) hypnorex 24-JUL- A: C: 1800Mg Cululative dose number (to first reaction) lithium carbonate 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) risperdal 23-JUN- 29-JUL- 37 Day A: Tagesdosis: 4-1 C:
Report Page: 5 of 7 Cululative dose number (to first reaction) risperidone 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) diazep 23-JUN- 28-JUL- 36 Day A: C: 30Mg Cululative dose number (to first reaction)
Report Page: 6 of 7 diazepam 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) risperdal 29-JUL- A: C: 1Mg Cululative dose number (to first reaction) risperidone 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 19.1 (10004908): Bipolar affective disorder ] Unknown Bipolare affektive Störung, gegenwärtig manische Episode mit psychotischen Symptomen Report duplicates Duplicate source Institut AGATE ggmbh Duplicate number SLÜ-00-051 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 where the reaction/event occur
Report Page: 7 of 7 Serious Date Format of receipt of the most recent information for this report Additional documents Yes 20170220 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 36 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 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