CIOMS FORM SUSPECT ADVERSE REACTION REPORT 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 63 DA MO YR (Year) Female 14 12 2015 Anschwellen von Fingern und Zehen (knallrot, dick an und total heiß) (10014210): Edema ] Anschwellen von Fingern und Zehen (knallrot, dick an und total heiß) (10015885): Extremities hot feeling of ] nächtliches Herzrasen und an Folgetagen (10066996): Heart racing ] (10013492): Distress respiratory ] Jucken am ganzen Körper (10037087): Pruritus ] starke innere Unruhe (10045556): Unrest ] regelrechtes Zittern (10044563): Trembling ] starke Übelkeit (10028813): Nausea ] drastischer Durchfall (10012727): Diarrhea ] Schmerzen im Bereich der Bauchspeicheldrüse (10059606): Pancreatic pain ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: 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.) dekristol 20000 I.E. (batch: 130729) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "1 x wöchentlich" {1 Week } Oral 17. INDICATION(S) FOR USE Osteoporosis 18. THERAPY DATES (from/to) 19. THERAPY DURATION from III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 20. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA 21. DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 18.1 (10037160): Psoriatic arthritis ] Continuing: [ MedDRA 18.1 (10028164): Multiple allergies ] Continuing: [ MedDRA 18.1 (10031282): Osteoporosis ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER BfArM 24b. MFR CONTROL NO. 24c. DATE RECEIVED BY 24d. REPORT SOURCE MANUFACTURER STUDY LITERATURE 01-FEB-2016 HEALTH PROFESSIONAL DATE OF THIS REPORT 11-FEB-2016 25a. REPORT TYPE þ IV. SENDER INFORMATION 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...) Bericht des Meldenden: Anschwellen von Fingern und Zehen (knallrot, dick an und total heiß) nächtliches Herzrasen und Luftnot Jucken am ganzen Körper starke innere Unruhe, regelrechtes Zittern diese Symptome mehrfach in der Nacht Herzrasen und die innere Unruhe auch an den Folgetagen ferner starke Übelkeit nach jeder Mahlzeit innerhalb von ca. 20 30 Min. drastischer Durchfall, Schmerzen im Bereich der Bauchspeicheldrüse Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Anschwellen von Fingern und Zehen (knallrot, dick an und total heiß) [MedDRA 18.1 PT (10030095): Oedema ] (10014210): Edema ] Time interval 1** Time interval 2*** Start date End date Anschwellen von Fingern und Zehen (knallrot, dick an und total heiß) [MedDRA 18.1 PT (10016334): Feeling hot ] (10015885): Extremities hot feeling of ] nächtliches Herzrasen und an Folgetagen [MedDRA 18.1 PT (10033557): Palpitations ] (10066996): Heart racing ] [MedDRA 18.1 PT (10038687): Respiratory distress ] (10013492): Distress respiratory ] Jucken am ganzen Körper [MedDRA 18.1 PT (10037087): Pruritus ] (10037087): Pruritus ] starke innere Unruhe [MedDRA 18.1 PT (10038743): Restlessness ] (10045556): Unrest ] regelrechtes Zittern [MedDRA 18.1 PT (10044565): Tremor ] (10044563): Trembling ]
Report Page: 3 of 6 starke Übelkeit [MedDRA 18.1 PT (10028813): Nausea ] (10028813): Nausea ] drastischer Durchfall [MedDRA 18.1 PT (10012735): Diarrhoea ] (10012727): Diarrhea ] Schmerzen im Bereich der Bauchspeicheldrüse [MedDRA 18.1 PT (10000087): Abdominal pain upper ] (10059606): Pancreatic pain ] * 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 Normal high More inform. 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Start End Duration Route(s) of Indication(s) Dose * dekristol 20000 I.E. (batch: 130729) 14-DEC- 2015 A: 1 x wöchentlich B: C: D: E: 1Week Oral Osteoporosis Identification of the country where the drug was obtained Name of holder/applicant Mibe GmbH 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: 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 colecalciferol Report Page: 4 of 6 Causality assessment Reaction Source Method Result [ MedDRA 18.1 (10015885): Extremities hot feeling of ] [ MedDRA 18.1 (10028813): Nausea ] [ MedDRA 18.1 (10037087): Pruritus ] [ MedDRA 18.1 (10044563): Trembling ] [ MedDRA 18.1 (10045556): Unrest ] [ MedDRA 18.1 (10059606): Pancreatic pain ] [ MedDRA 18.1 (10066996): Heart racing ] [ MedDRA 18.1 (10012727): Diarrhea ] [ MedDRA 18.1 (10013492): Distress respiratory ] [ MedDRA 18.1 (10014210): Edema ] 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 18.1 (10037160): Psoriatic arthritis ] [ MedDRA 18.1 (10028164): Multiple allergies ] [ MedDRA 18.1 (10031282): Osteoporosis ] [ MedDRA 18.1 (10003555): Asthma bronchial ] [ MedDRA 18.1 (10020775): Hypertension arterial ] Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2015010891 Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0
Report Page: 5 of 6 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the Deutschland Serious Date Format of receipt of the most recent information for this report Additional documents 20160201 No List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? DE-CADRBFARM-2015010891 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 58 Deutschland Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority BfArM Street address City Bonn Postcode 53175 Country Deutschland 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.
Report Page: 6 of 6 Weight (kg) 42 Height (cm) 153 Last menstrual periode date Text for relevant medical history and concurrent conditions