SUSPECT ADVERSE REACTION REPORT

Transcription

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 zunehmende Dyspnoe ( ): Dyspnoea ] ( ): Fall ] ( ): Gait disturbance ] axonal-dimyelinisierende sensomotorische Polyneuropathie ( ): Polyneuropathy NOS ] V.a. Lungenfibrose ( ): Pulmonary fibrosis ] respiratorische Globalinsuffizienz ( ): Respiratory failure ] Reporter's comments: DE DA MO YR 67 DA MO YR (Year) Male Sonstiges: Patient wurde zur Abklärung seiner zunehmenden Dyspnoe (Lungenfibrose) eingewiesen. Nach ERCP wegen Choledocholithiasis Tod bei Sepsis. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED 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.) amiodaron 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 200 Mg millgram(s) every Days" { 200 Mg milligram(s), 1 in 1 Day } 17. INDICATION(S) FOR USE Cardiac arrhythmia 18. THERAPY DATES (from/to) 19. THERAPY DURATION 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) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.0 ( ): Atrial fibrillation ] Continuing: No [ MedDRA 19.0 ( ): Hypertension ] Continuing: No [ MedDRA 19.0 ( ): Chronic obstructive pulmonary disease ] Continuing: No (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 11-AUG- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL 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*** Start date End date zunehmende Dyspnoe [MedDRA 19.0 PT ( ): Dyspnoea ] ( ): Dyspnoea ] [MedDRA 19.0 PT ( ): Fall ] ( ): Fall ] [MedDRA 19.0 PT ( ): Gait disturbance ] 28-JUL-2015 ( ): Gait disturbance ] axonal-dimyelinisierende sensomotorische Polyneuropathie [MedDRA 19.0 PT ( ): Polyneuropathy ] 28-JUL-2015 ( ): Polyneuropathy NOS ] V.a. Lungenfibrose [MedDRA 19.0 PT ( ): Pulmonary fibrosis ] ( ): Pulmonary fibrosis ] respiratorische Globalinsuffizienz [MedDRA 19.0 PT ( ): Respiratory failure ] ( ): Respiratory failure ] * 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 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start date End date Duration Dose * Route(s) of Administration Indication(s) amiodaron A: daily dose: 200 Mg millgram(s) every Days B: C: 200Mg Cardiac arrhythmia

3 Report Page: 3 of 5 milligram(s) D: 1 E: 1Day 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 Beginn einer Aufsättigung mit Amiodaron am 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 amiodarone Causality assessment Reaction Source Method Result [ MedDRA 19.0 ( ): Dyspnoea ] [ MedDRA 19.0 ( ): Pulmonary fibrosis ] [ MedDRA 19.0 ( ): Respiratory failure ] 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 19.0 ( ): Atrial fibrillation ] No ICD I48 [ MedDRA 19.0 ( ): Hypertension ] No ICD I10 [ MedDRA 19.0 ( ): Chronic obstructive pulmonary disease ] No ICD J44 [ MedDRA 19.0 ( ): Choledocholithiasis ] No [ MedDRA 19.0 ( ): ERCP ] No

4 Report Page: 4 of 5 [ MedDRA 19.0 ( ): Post procedural sepsis ] No Sepsis bei Cholangitis bei Choledocholithiasis und Gallenstau Report duplicates Duplicate source Duplicate number DE-DCGMA Patient death Date of death 01-MAY- Was autopsy done? No Patient death cause MedDRA version for reported cause(s) of death [ MedDRA 19.0 ( ): Respiratory failure ] [ MedDRA 19.0 ( ): Pneumonia ] Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 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? 0811 medical report, death Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? 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

5 Report Page: 5 of 5 07 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) 80 Height (cm) 175 Last menstrual periode date Text for relevant medical history and concurrent conditions