CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17201007 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 71 DA MO YR (Year) Male 19 05 Pneumonitis mit begleitendem Pneumothorax und Pneumomediastinum nach Chemotherapie mit Bleomycin [ MedDRA 20.0 LLT (10035742): Pneumonitis ] [ MedDRA 20.0 LLT (10035759): Pneumothorax ] [ MedDRA 20.0 LLT (10050184): Pneumomediastinum ] 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION Reporter's comments: Maßnahmen: intensivmedizinische Behandlung, Indikation für Intubation und Thoraxdrainage, Verzicht aufgrund Maßnahmenbeschränkung. In diesem speziellen Fall Exitus letalis bei Limitation der gewünschten Maßnahmen (DNR/DNI). INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION 14. SUSPECT DRUG(S) (include generic name) bleomycin II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 17. INDICATION(S) FOR USE Hodgkin's disease stage III 18. THERAPY DATES (from/to) 19. THERAPY DURATION from FEB- to APR- 60 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) adriamycin from FEB- to APR- adriamycin from FEB- to APR- (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 20.0 (10008025): Cerebellar ataxia ] Continuing: No [ MedDRA 20.0 (10012267): Dementia ] Continuing: No (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER 10623 Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 26-MAY- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17201007 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 9 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*** Pneumonitis mit begleitendem Pneumothorax und Pneumomediastinum nach Chemotherapie mit Bleomycin [MedDRA 20.0 PT (10035742): Pneumonitis ] fatal 19-MAY- [ MedDRA 20.0 LLT (10035742): Pneumonitis ] [MedDRA 20.0 PT (10035759): Pneumothorax ] [ MedDRA 20.0 LLT (10035759): Pneumothorax ] fatal 19-MAY- [MedDRA 20.0 PT (10050184): Pneumomediastinum ] [ MedDRA 20.0 LLT (10050184): Pneumomediastinum ] fatal 19-MAY- * 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 19-MAY- Leucocyte count 11.4 NA 22-MAY- Leucocyte count 13.7 NA 24-MAY- Leucocyte count 13.9 NA 24-MAY- Eosinophil count 0.0 % 19-MAY- C-reactive protein 2.0 mg/dl 22-MAY- C-reactive protein 1.8 mg/dl 24-MAY- C-reactive protein 1.0 mg/dl MAY- Creatinine stets normwertig NA MAY- Urea durchgehend: 80 (+/- 8) mg/dl 19-MAY- Haemoglobin 12.8 g/dl 22-MAY- Haemoglobin 10.8 g/dl 24-MAY- Haemoglobin 11.6 g/dl 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of bleomycin FEB- APR- 60 Day A: C: D: E: Hodgkin's disease stage III
Report Page: 3 of 9 3 Month 49 Day Drug withdrawn insgesamt 3 Zyklen Cumulative dose number (to first reaction) C: Structure dosages number bleomycin Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10035742): Pneumonitis ] [ MedDRA 20.0 (10035759): Pneumothorax ] [ MedDRA 20.0 (10050184): Pneumomediastinum ] AkdÄ AkdÄ AkdÄ possible possible possible 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) adriamycin FEB- APR- 60 Day A: C: D: E: Hodgkin's disease stage III
Report Page: 4 of 9 3 Month 49 Day doxorubicin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) dacarbazin FEB- APR- 60 Day A: C: D: E: Hodgkin's disease stage III 3 Month 49 Day dacarbazine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...)
Report Page: 5 of 9 mcp A: daily dose: 20 Mg millgram(s) every Days C: 10Mg milligram(s) D: 2 E: 1Day Oral metoclopramide hydrochloride 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) pantoprazol A: daily dose: 40 Mg millgram(s) every Days C: 40Mg milligram(s) D: 1 E: 1Day Oral
Report Page: 6 of 9 pantoprazole 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) dexamethason A: daily dose: 4 Mg millgram(s) every Days C: 4Mg milligram(s) D: 1 E: 1Day Oral Chemotherapy dexamethasone 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...)
Report Page: 7 of 9 levofloxacin 27-APR- 19-MAY- 23 Day A: daily dose: 500 Mg millgram(s) every Days 11500Mg milligram(s) C: 500Mg milligram(s) D: 1 E: 1Day Oral 23 Day levofloxacin 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10008025): Cerebellar ataxia ] No Kleinhirnataxie [ MedDRA 20.0 (10012267): Dementia ] No beginnende Demenz Report duplicates Duplicate source Duplicate number DE-DCGMA-17173796 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0
Report Page: 8 of 9 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 Yes 0526 No List of documents held by sender Does this case fulfill the local criteria for an expedited 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 64 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) 60 168
Report Page: 9 of 9 Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions