SUSPECT ADVERSE REACTION REPORT

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1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Lungenembolie rechter Unterlappen [ MedDRA 20.0 LLT ( ): Pulmonary embolism ] V. a. Pulmonalvenenthrombose [ MedDRA 20.0 LLT ( ): Pulmonary venous thrombosis ] Results of tests and procedures relevant to the investigation of the patient: CT-Befund: "... bei gut Pulmonal-arterieller Kontrastierung LAE in Subsegment A2 und3 rechts, sowie hochwahrscheinlich auch im schlecht kontrastierten rechten Unterlappen. Hier auffällige langsteckige Dilatation der Pulmonalvenen bei Weichteildichte, teils aber auch Mischkontrast zwischen 100 und 120 HE. Hier kein Nachweis umflossener Thromben..." Reporter's comments: DE DA MO YR 79 DA MO YR (Year) Male CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED þ þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT Maßnahme: Einleitung Antikoagulation 14. SUSPECT DRUG(S) (include generic name) ofev II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 300 Mg millgram(s) every Days" { 150 Mg milligram(s), 2 in 1 Day } 17. INDICATION(S) FOR USE Lung fibrosis 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 2015 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) prednisolon from DEC-2016 to 2017 hct (cont.) 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 20.0 ( ): Lung fibrosis ] Continuing: Unknown [ MedDRA 20.0 ( ): Emphysema pulmonary ] Continuing: Unknown [ MedDRA 20.0 ( ): Nicotine abuse ] Continuing: No (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 08-AUG-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of 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*** Lungenembolie rechter Unterlappen [MedDRA 20.0 PT ( ): Pulmonary embolism ] not recovered/not resolved 29-DEC-2016 [ MedDRA 20.0 LLT ( ): Pulmonary embolism ] V. a. Pulmonalvenenthrombose [MedDRA 20.0 PT ( ): Pulmonary venous thrombosis ] not recovered/not resolved 29-DEC-2016 [ MedDRA 20.0 LLT ( ): Pulmonary venous thrombosis ] * 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 29-DEC-2016 Computerised tomogram vorhanden/present NA 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of ofev 2015 A: daily dose: 300 Mg millgram(s) every Days C: 150Mg milligram(s) D: 2 E: 1Day Lung fibrosis 1 Year Dose not changed

3 Report Page: 3 of 6 Cumulative dose number (to first reaction) C: Structure dosages number nintedanib Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Pulmonary embolism ] AkdÄ Global Introspection (WHO GI) possible [ MedDRA 20.0 ( ): Pulmonary venous thrombosis ] AkdÄ Global Introspection (WHO GI) possible 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of prednisolon DEC A: C: D: E: Exacerbation of idiopathic pulmonary fibrosis 29 Day Drug withdrawn Cululative dose number (to first reaction) C: Structure of separate dosages prednisolone 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of hct A: Hypertension arterial

4 Report Page: 4 of 6 C: D: E: Dose not changed Cululative dose number (to first reaction) C: Structure of separate dosages hydrochlorothiazide 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of losartan A: C: D: E: Hypertension arterial Dose not changed

5 Report Page: 5 of 6 Cululative dose number (to first reaction) C: Structure of separate dosages losartan 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Lung fibrosis ] Unknown idiopathische Lungenfibrose [ MedDRA 20.0 ( ): Emphysema pulmonary ] Unknown Lungenemphysem bei Z. n. Nikotinabusus [ MedDRA 20.0 ( ): Nicotine abuse ] No Z. n. Nikotinabusus, ca. 27 py [ MedDRA 20.0 ( ): Hypertension arterial ] Unknown Report duplicates Duplicate source Duplicate number DE-DCGMA Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 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? manufactures questionnaire Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional?

6 Report Page: 6 of 6 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 Country Fax +49 / (0) / Telephone +49 / (0) / address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 85 Height (cm) 182 Last menstrual periode Text for relevant medical history and concurrent conditions

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