CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17326018 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 (10012218): Delirium ] (10020583): Hypercalcaemia ] (10038701): Respiratory insufficiency ] (10050729): Self-medication ] (10022727): Intoxication ] (10021590): Inappropriate dose of drug administered ] (10068230): Cardiorenal syndrome ] (10001041): Acute renal failure ] Results of tests and procedures relevant to the investigation of the patient: 60 DA MO YR (Year) Male Histopathologischer Bericht vom 07.08.: Schwer diffuser, potenziell nur zu einem Teil reversibler Tubulusschaden der Rinde, herdförmig mit tubulointerstitiellen Mikroverkalkungen. Hinweise für eine maligne Grunderkrankung, eine Sarkoidose, einem Lymphom oder einen primären Hyperparathyreoidismus fanden sich nicht. 8-1 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.) vitamin d 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 50000 Iu international unit(s) every Day" { 50000 Oral Iu international unit(s), 1 in 1 Day } 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) l-carnitin magnesium (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10029783): Normochromic normocytic anaemia ] Continuing: Unknown [ MedDRA 20.0 (10021114): Hypothyroidism ] Continuing: Unknown [ MedDRA 20.0 (10020775): Hypertension arterial ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 29-SEP- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17326018 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 10 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reporter's comments: Verlauf: Vitamin D 50.000 IE aus Polen besorgt und 3x tgl. 1 Tbl. eingenommen. Zudem Selbstmedikation diverser Vitamine und Nahrungsergänzungsmittel. Keine Tablette für Blutdruck und Schilddrüse mehr genommen. Maßnahme: NIV-Beatmung 21.-26.07.. Hämodialyse seit 24.07.. Passagerer Shaldonkatheter rechte Vena jugularis. Transfusion von 5 EKs und 2 FFPs. Intensivstation. Prednisolontherapie. Sender's comment: Ergänzung Reporter`s comments: Informationen zum Medikationsfehler. Umfeld: keine Angabe. Schritt im Medikationsprozess: Einnahme/Applikation. Risikofaktoren: keine Angabe. Empfehlung zur Fehlervermeidung: keine Angabe. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT (10012218): Delirium ] (10012218): Delirium ] [MedDRA 20.0 PT (10020583): Hypercalcaemia ] (10020583): Hypercalcaemia ] [MedDRA 20.0 PT (10038695): Respiratory failure ] (10038701): Respiratory insufficiency ] [MedDRA 20.0 PT (10050729): Self-medication ] (10050729): Self-medication ] [MedDRA 20.0 PT (10061355): Poisoning ] (10022727): Intoxication ] [MedDRA 20.0 PT (10064355): Incorrect dose administered ] (10021590): Inappropriate dose of drug administered ] [MedDRA 20.0 PT (10068230): Cardiorenal syndrome ] (10068230): Cardiorenal syndrome ]
Report Page: 3 of 10 [MedDRA 20.0 PT (10069339): Acute kidney injury ] (10001041): Acute renal failure ] * 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 02-AUG- Biopsy kidney vorhanden/present NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of vitamin d A: daily dose: 50000 Iu international unit(s) every Day 50000Iu international unit(s) 1 1Day Oral Cumulative dose number (to first reaction) Structure dosages number vitamin d Causality assessment
Report Page: 4 of 10 Reaction Source Method Result [ MedDRA 20.0 (10012218): Delirium ] AkdÄ Global Introspection (WHO GI) possible [ MedDRA 20.0 (10020583): Hypercalcaemia ] AkdÄ Global Introspection (WHO GI) possible [ MedDRA 20.0 (10038701): Respiratory insufficiency ] AkdÄ Global Introspection (WHO GI) possible [ MedDRA 20.0 (10068230): Cardiorenal syndrome ] AkdÄ Global Introspection (WHO GI) possible [ MedDRA 20.0 (10001041): Acute renal failure ] AkdÄ Global Introspection (WHO GI) possible 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) l-carnitin A: Cululative dose number (to first reaction) Structure of separate dosages carnitine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) magnesium A:
Report Page: 5 of 10 Cululative dose number (to first reaction) Structure of separate dosages magnesium 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) vitamin k A:
Report Page: 6 of 10 Cululative dose number (to first reaction) Structure of separate dosages phytomenadione 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) vitamin b6 A: Cululative dose number (to first reaction) Structure of separate dosages pyridoxine hydrochloride 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) liver detox A:
Report Page: 7 of 10 Cululative dose number (to first reaction) Structure of separate dosages curcuma longa 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) ubiquinol coq A: Cululative dose number (to first reaction) Structure of separate dosages coenzym q10
Report Page: 8 of 10 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) kalzium A: Cululative dose number (to first reaction) Structure of separate dosages calcium 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10029783): Normochromic normocytic anaemia ] Unknown Normozytäre, normochrome Anämie DD renale Anämie. [ MedDRA 20.0 (10021114): Hypothyroidism ] Unknown [ MedDRA 20.0 (10020775): Hypertension arterial ] Unknown Report duplicates Duplicate source Duplicate number DE-DCGMA-17174703 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0
Report Page: 9 of 10 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 0929 Yes medical report, telephone call 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 22 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 Adult >18.Lj. bis einschl. 65.Lj. Weight (kg)
Report Page: 10 of 10 Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions