CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17248909 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 (10024378): Leukocytosis ] (10039020): Rhabdomyolysis ] (10029282): Neuroleptic malignant syndrome ] (10015667): Exhaustion ] (10042174): Strength loss of ] (10050218): Difficulty in standing ] (10011336): Creatine kinase increased ] (10005802): Blood sodium decreased ] 54 DA MO YR (Year) Male 21 06 Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Beobachtete unerwünschte Wirkungen: Patient plötzlich erschöpft, kraftlos, konnte kaum mehr alleine stehen. Die Blutabnahme zeige erhöhte Kreatininkinasewerte und erniedrigte Natriumwerte. Der Patient wurde zur Abklärung auf die Intensivstation verlegt. Sonstige Ursachen wurden ausgeschlossen. Verdacht auf malignes neuroleptisches Syndrom. Dies wurde auch im Krankenhaus festgestellt. 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED þ þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) zyprexa velotab 20 mg 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 20 Mg milligram(s),1 Day Oral 17. INDICATION(S) FOR USE Chronic schizophrenia 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 2008 to 22-JUN- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) diazepam from 1989 to 22-JUN- 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 (10009134): Chronic schizophrenia ] Continuing: Unknown [ MedDRA 20.0 (10035664): Pneumonia ] Continuing: Unknown [ MedDRA 20.0 (10008841): Chronic bronchitis ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 12-JUL- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17248909 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...) Verlauf der Therapie der unerwünschten Wirkung: Behandlung intensivmedizinisch (Absetzen der Medikamente Zyprexa, Fluphenazin und Citazyl-z). Die Trinkmenge wurde auf maximal 3 Liter pro Tag reduziert. Die Beschwerden waren rückläufig und der Patient konnte wieder in die Psychiatrie zurückverlegt werden. Results of tests and procedures relevant to the investigation of the patient: Fluphenazin am 21.06. 3.30 (Referenzbereich 0.50-2.00) Zuclopenthix am 21.06. 136.00 (Referenzbereich 4-50) Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT (10029282): Neuroleptic malignant syndrome ] (10029282): Neuroleptic malignant syndrome ] [MedDRA 20.0 PT (10016256): Fatigue ] (10015667): Exhaustion ] [MedDRA 20.0 PT (10003549): Asthenia ] (10042174): Strength loss of ] [MedDRA 20.0 PT (10050256): Dysstasia ] (10050218): Difficulty in standing ] [MedDRA 20.0 PT (10005470): Blood creatine phosphokinase increased ] (10011336): Creatine kinase increased ] [MedDRA 20.0 PT (10005802): Blood sodium decreased ] (10005802): Blood sodium decreased ] [MedDRA 20.0 PT (10024378): Leukocytosis ] (10024378): Leukocytosis ] [MedDRA 20.0 PT (10039020): Rhabdomyolysis ] (10039020): Rhabdomyolysis ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** and start of reaction/event
Report Page: 3 of 7 Results of tests Date Test Result Unit Normal low range Normal high range More inform. available Leucocyte count 15.7 NA 4.0 10.0 Red blood cell count 4.22 NA 4.50 5.90 Haemoglobin 13.1 NA 13.5 17.5 Haematocrit 36.7 NA 40 53 Lymphocyte count 4.9 % 25.0 50.0 Neutrophil count 90.3 % 50 70 Aspartate aminotransferase 40 NA 5 34 LDH 284 NA 125 220 Creatine kinase 1041 NA 20 200 Creatine kinase MB 43 NA 0 25 C-reactive protein 3.36 NA 0 0.5 GFR 143 NA 90 120 Creatinine 0.62 NA 0.7 1.25 Urea 9.3 NA 18 55 Sodium 110 NA 136 146 Chloride 73 NA 98 107 Magnesium 0.64 NA 0.66 1.07 Blood glucose 120 NA 70 110 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of zyprexa velotab 20 mg 2008 22-JUN- C: 20Mg milligram(s) Oral Chronic schizophrenia
Report Page: 4 of 7 Drug withdrawn * Dosage Text Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages olanzapine 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of fluphenazine decanoate 2005 22-JUN- C: 1ml millilitre(s) Intramuscular Chronic schizophrenia Drug withdrawn * Dosage Text Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages fluphenazine decanoate 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of ciatyl-z 2004 22-JUN- C: 200Mg milligram(s) Oral Schizophrenia
Report Page: 5 of 7 Drug withdrawn * Dosage Text Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages zuclopenthixol hydrochloride 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of diazepam 1989 22-JUN- C: 20Mg milligram(s) Oral Anxiety * Dosage Text
Report Page: 6 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages diazepam 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10009134): Chronic schizophrenia ] Unknown [ MedDRA 20.0 (10035664): Pneumonia ] Unknown Pneumoni rechts basal akut [ MedDRA 20.0 (10008841): Chronic bronchitis ] Unknown [ MedDRA 20.0 (10048880): Smoker ] Unknown [ MedDRA 20.0 (10036067): Polydipsia ] Unknown Patient trinkt massiv Flüssigkeit (Wasser und Kaffee) 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 0712 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? 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 41 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address
Report Page: 7 of 7 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) 70 Height (cm) 176 Last menstrual periode Text for relevant medical history and concurrent conditions