CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17085373 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 67 DA MO YR (Year) Female 01 02 2017 (10003445): Ascites ] (10020942): Hypoalbuminaemia ] (10020947): Hypocalcaemia ] toxische Hepatopathie mit Lebersynthesestörung (10059616): Hepatopathy ] (10050396): Subileus ] 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) 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) eliquis II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 10 Mg millgram(s) every Days" [ 1240 Mg Oral milligram(s) { 5 Mg milligram(s), 2 in 1 Day } ] 17. INDICATION(S) FOR USE Deep vein thrombosis leg 18. THERAPY DATES (from/to) 19. THERAPY DURATION from OCT-2016 to FEB-2017 4 Month III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) kalzium BT daily dose: 1 Df dosage form every Days kalzium BT daily dose: 1 Df dosage form every Days (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 (10021114): Hypothyroidism ] Continuing: Unknown [ MedDRA 19.1 (10022000): Influenza ] Continuing: Unknown [ MedDRA 19.1 (10002034): Anaemia ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 06-MAR-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17085373 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 8 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 19.1 PT (10003445): Ascites ] (10003445): Ascites ] [MedDRA 19.1 PT (10020942): Hypoalbuminaemia ] (10020942): Hypoalbuminaemia ] [MedDRA 19.1 PT (10020947): Hypocalcaemia ] (10020947): Hypocalcaemia ] toxische Hepatopathie mit Lebersynthesestörung [MedDRA 19.1 PT (10024670): Liver disorder ] (10059616): Hepatopathy ] [MedDRA 19.1 PT (10050396): Subileus ] (10050396): Subileus ] * 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 Hepatitis A antibody Epstein-Barr virus test positiv/positive EBV EBNA-IgG-AK: 520 E/ml NA NA Herpes simplex antibody HSV 1/2 IgG-AK: positiv NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of eliquis OCT- 2016 FEB- 2017 4 Month A: daily dose: 10 Mg millgram(s) every Days B: 1240Mg milligram(s) C: 5Mg milligram(s) D: 2 E: 1Day Oral Deep vein thrombosis leg
Report Page: 3 of 8 4 Month Drug withdrawn B: Cumulative dose number (to first reaction) C: Structure dosages number apixaban Causality assessment Reaction Source Method Result [ MedDRA 19.1 (10003445): Ascites ] Global Introspection (WHO GI) [ MedDRA 19.1 (10020942): Hypoalbuminaemia ] [ MedDRA 19.1 (10020947): Hypocalcaemia ] [ MedDRA 19.1 (10059616): Hepatopathy ] [ MedDRA 19.1 (10050396): Subileus ] 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of kalzium BT A: daily dose: 1 Df dosage form every Days B: C: 1Df dosage form D: 1 E: 1Day
Report Page: 4 of 8 B: Cululative dose number (to first reaction) C: Structure of separate dosages calcium 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of pantozol A: daily dose: 40 Mg millgram(s) every Days B: C: 40Mg milligram(s) D: 1 E: 1Day B: Cululative dose number (to first reaction)
Report Page: 5 of 8 C: Structure of separate dosages pantoprazole sodium 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of torem A: B: C: 5Mg milligram(s) D: E: B: Cululative dose number (to first reaction) C: Structure of separate dosages torasemide 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of dekristol A: daily dose: 2000 Iu international unit(s) every Days B: C: 1000Iu international unit(s) D: 2 E: 1Day
Report Page: 6 of 8 B: Cululative dose number (to first reaction) C: Structure of separate dosages colecalciferol 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 19.1 (10021114): Hypothyroidism ] Unknown [ MedDRA 19.1 (10022000): Influenza ] Unknown Influenza Typ A [ MedDRA 19.1 (10002034): Anaemia ] Unknown [ MedDRA 19.1 (10017853): Gastritis ] Unknown [ MedDRA 19.1 (10047626): Vitamin D deficiency ] Unknown [ MedDRA 19.1 (10076649): Sigmoid diverticulosis ] Unknown [ MedDRA 19.1 (10037377): Pulmonary embolism ] No [ MedDRA 19.1 (10047697): Volvulus ] No Z.n. Volvulus mit Darmdetorquierung [ MedDRA 19.1 (10057396): Thrombophilia ] Unknown [ MedDRA 19.1 (10043570): Thrombophlebitis ] Unknown Report duplicates Duplicate source Duplicate number DE-DCGMA-17172906 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0
Report Page: 7 of 8 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 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Yes 20170306 Yes Medical 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 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 38 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode 10623 Country Fax +49 / (0)30 4004 / 56555 Telephone +49 / (0)30 4004 / 56500 E-mail address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg)
Report Page: 8 of 8 Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions