CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200374 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10049347): Cracked lips ] Ermüdung (10016256): Fatigue ] offene entzündende Lippen (10049345): Inflammation lips ] Croh-like-Colitis (10011400): Crohn's colitis ] Schlafstörung (10013268): Disorder sleep ] (10023002): Irritable bowel ] (10000081): Abdominal pain ] Antrumgastritis (10076492): Antral gastritis ] (10061958): Food intolerance ] Durchfall (10012727): Diarrhea ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DA MO YR 16 DA MO YR (Year) Female 05 12 Seit Dezember ziehende Bauchschmerzen, massive Durchfälle bis zu 10x täglich mit chronisch entzündlicher Darmerkrankung: Terminale Ileitis, Antrumgastritis, teilweise wiederhergestellt, es besteht nach wie vor ein Reizdarm, Nahrungsmittelunverträglichkeiten, die vorher nicht bekannt 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) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 30 Mg milligram(s),1 Day Oral 17. INDICATION(S) FOR USE DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from APR- to SEP- 5 Month III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) (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 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10029263): Neurodermatitis ] Continuing: [ MedDRA 20.0 (10014315): Egg allergy ] Continuing: No [ MedDRA 20.0 (10000496): ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 20-JUN-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17200374 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...) waren. Ermüdung und Schlafstörungen seit ca. Sommer ; Ermüdung wiederhergestellt, Schlafstörung teilweise wieder hergestellt. Massive offene entzündete gesprungene Lippen während der gesamten Einnahme des Medikamentes. Komedikation: Kontrazeptiva; abgesetzt Dezember wegen der starken Duchfälle Folgemelduung der behandelnden ÄrztinJuni 2017: Crohn-like Colitis Anfang Dezember bis Juni 2016. Unter exklusiver Ernährungstherapie und teilweise glutenfreier Ernährung rezidivfreie Restitutio ad integrum. Results of tests and procedures relevant to the investigation of the patient: Die Immunhistochemie bezüglich Heliobacter pylori ist negativ. Akute fokale Duodenitis. Keine Parasiten. Kein Hinweis für Sprue Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Durchfall [MedDRA 20.0 PT (10012735): Diarrhoea ] 05-DEC- (10012727): Diarrhea ] Ermüdung [MedDRA 20.0 PT (10016256): Fatigue ] 7 Month recovered/resolved 01-NOV- 01-JUN-2016 (10016256): Fatigue ] Schlafstörung [MedDRA 20.0 PT (10040984): Sleep disorder ] recovering/resolving 01-MAY- (10013268): Disorder sleep ] offene entzündende Lippen [MedDRA 20.0 PT (10008417): Cheilitis ] 7 Month recovered/resolved 01-MAY- 15-DEC- (10049345): Inflammation lips ] [MedDRA 20.0 PT (10000081): Abdominal pain ] 05-DEC- (10000081): Abdominal pain ] Croh-like-Colitis [MedDRA 20.0 PT (10011401): Crohn's disease ] recovering/resolving 05-DEC- (10011400): Crohn's colitis ] Antrumgastritis [MedDRA 20.0 PT (10017853): Gastritis ] 05-DEC-
Report Page: 3 of 7 (10076492): Antral gastritis ] [MedDRA 20.0 PT (10049047): Chapped lips ] 7 Month recovered/resolved 01-MAY- 15-DEC- (10049347): Cracked lips ] [MedDRA 20.0 PT (10061958): Food intolerance ] (10061958): Food intolerance ] [MedDRA 20.0 PT (10023003): Irritable bowel syndrome ] not recovered/not resolved (10023002): Irritable bowel ] * 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 JAN- Red blood cell sedimentation rate normal/normal JAN-2016 Culture stool ohne Befund 25-JAN-2016 Faecal calprotectin 934 ug/g 02-FEB-2016 Weight 55.2 kg 02-FEB-2016 Ultrasound abdomen Gastroscopy Biopsy intestine Colonoscopy 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) APR- SEP- 5 Month A: B: C: 30Mg milligram(s) D: E: 1Day Oral 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: 4 of 7 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 isotretinoin 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) OCT- NOV- 32 Day A: B: C: 20Mg milligram(s) D: E: 1Day Oral 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: 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 isotretinoin 14. Suspect Drug(s) (including generic name) (... continuation...) Dose * Indication(s)
Report Page: 5 of 7 Suspect Drug and batch no. Start End Route(s) of Administration DEC- DEC- 1 Month A: B: C: 10Mg milligram(s) D: E: 1Day Oral 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: 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 isotretinoin 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 (10029263): Neurodermatitis ] [ MedDRA 20.0 (10014315): Egg allergy ] No Zustand nach Hühnerei-Allergie [ MedDRA 20.0 (10000496): ] Akne juvenilis Grad III [ MedDRA 20.0 (10001705): Allergic asthma ] [ MedDRA 20.0 (10061958): Food intolerance ] Weizen Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017016966 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions
Report Page: 6 of 7 0 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 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? Deutschland 20170620 Facharztbericht DE-CADRBFARM-2017016966 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 79 Deutschland Consumer or other non health professional 79 Deutschland Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Deutschland Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number
Report Page: 7 of 7 Gestation period Patient age group Adolescent >12.Lj. bis einschl. 18.Lj. Weight (kg) 60 Height (cm) 170 Last menstrual periode Text for relevant medical history and concurrent conditions