CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16186976 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET DA MO YR 38 DA MO YR (Year) Female 27 05 2016 (10013482): Distention ] (10023222): Joint pain ] (10006002): Bone pain ] (10013573): Dizziness ] "grippeartige Müdigkeit" (10043890): Tiredness ] "Unfähigkeit aufzustehen" (10028035): Movement disorder ] (10034899): Phlebitis NOS ] (10038687): Respiratory distress ] (10016065): Facial swelling ] (10014018): Ear noises ] (10042695): Swelling of hands ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Telefonischer Bericht der Meldenden: Patientin mit metastasierendem Mamakarzinom, Metastasen in allen Organen. Verordnung von Lonquex aufgrund niedriger Leukozytenzahl bei Chemotherapie mit Abraxane (125 mg/m2), zusätzlich Lyrica (25 mg 1x tgl.) als Schmerzmitte. Erste Lonquex-lnjektion am 26.05.2016. 36 h später grippeartiges Gefühl. 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) Lonquex 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "1 Spritze am 26.05.2016" { 1 Df dosage form, 1 separate Subcutaneous dose } privacy 17. INDICATION(S) FOR USE Leukopenia DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 26-MAY-2016 to 26-MAY-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) lyrica daily dose: 25 Mg milligram(s) every Day (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 (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.0 (10055113): Breast cancer metastatic ] Continuing: Yes (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16186976 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 6 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Nach 48 Stunden Anschwellen von Gesicht und Händen, starke Atemnot (über 2 Tage, von der Patientin als schwerwiegend beschrieben), Gelenk- und Knochenschmerzen, Bewegungsstörungen (Unfähigkeit aufzustehen), Schwindel, Ohrensausen, Völlegefühl, Venenentzündung. Seit 30.5.16 Einnahme von lbuprofen (600 mg), dadurch Abklingen der Bewegungsapparat-assoziierten Störungen. Ebenfalls abgeklungen ist die Gesichtsschwellung, Schwellung der Hände deutlich verbessert. Andere UAWs anhaltend. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End "grippeartige Müdigkeit" [MedDRA 19.0 PT (10016256): Fatigue ] (10043890): Tiredness ] 2 Day 2 Day 27-MAY-2016 [MedDRA 19.0 PT (10042682): Swelling face ] (10016065): Facial swelling ] 4 Day recovered/ [MedDRA 19.0 PT (10048959): Peripheral swelling ] (10042695): Swelling of hands ] [MedDRA 19.0 PT (10038687): Respiratory distress ] (10038687): Respiratory distress ] 2 Day recovered/ Yes, highlighted by the reporter, SERIOUS 29-MAY-2016 [MedDRA 19.0 PT (10003239): Arthralgia ] (10023222): Joint pain ] 4 Day recovered/ [MedDRA 19.0 PT (10006002): Bone pain ] (10006002): Bone pain ] 4 Day recovered/ [MedDRA 19.0 PT (10013573): Dizziness ] (10013573): Dizziness ] [MedDRA 19.0 PT (10043882): Tinnitus ] (10014018): Ear noises ] [MedDRA 19.0 PT (10000060): Abdominal distension ] (10013482): Distention ] [MedDRA 19.0 PT (10034879): Phlebitis ]
Report Page: 3 of 6 (10034899): Phlebitis NOS ] "Unfähigkeit aufzustehen" [MedDRA 19.0 PT (10028035): Movement disorder ] (10028035): Movement disorder ] Unknown MAY-2016 * 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 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) Lonquex 26-MAY- 26-MAY- 2016 2016 A: 1 Spritze am 26.05.2016 B: C: 1Df dosage form D: 1 E: Subcutaneous Leukopenia 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 Indikation: Chemotherapie-induzierte Leukozytaemie 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 LIPEGFILGRASTIM 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...)
Report Page: 4 of 6 Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) lyrica A: daily dose: 25 Mg milligram(s) every Day B: C: 25Mg milligram(s) D: 1 E: 1Day Oral Pain management 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 pregabalin Interacting Drug(s) and Dates of Administration (... continuation...) Interacting Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) abraxane A: B: C: 125mg/m2 milligram(s)/sq. meter D: E: Intravenous (not otherwise specified) Metastatic breast cancer 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)
Report Page: 5 of 6 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 paclitaxel 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.0 (10055113): Breast cancer metastatic ] Yes Metastasen in allen Organen 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 20160531 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 Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 37 Consumer or other non health professional SENDER INFORMATION (... continuation...)
Report Page: 6 of 6 Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 62 Height (cm) 164 Last menstrual periode Text for relevant medical history and concurrent conditions