SUSPECT ADVERSE REACTION REPORT
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- Pamela Esser
- vor 6 Jahren
- Abrufe
Transkript
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 DA MO YR 32 DA MO YR (Year) Female Depression ( ): Depression ] Angstattacken ( ): Anxiety attack ] Gewichtszunahme ( ): Weight gain ] Unterleibsschmerzen ( ): Lower abdominal pain ] verminderte Libido ( ): Libido decreased ] Erschöpfung ( ): Exhaustion ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden Einsetzen am Beginn der Nebenwirkungen ca. zum Herausnahme des Präparats am Nebenwirkungen bestehen in milderer Form weiter und bessern sich langsam, seitdem die Medikation geendet hat. Die Dauer der Nebenwirkung/Beschwerden habe ich daher für die Tragezeit eingegeben, jedoch bestehen weiterhin noch starke Beeinträchtigungen! Anschlussbehandlungen vor allem durch die psychischen Auswirkungen notwendig. Nebenwirkungen wurden bei Gynäkologen angegeben, dort hieß es allerdings, dass hierbei kein Zusammenhang bestünde, da ich diesbezüglich vorbelastet sei und es nur Zufall sein könnte, dass II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) mirena 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION Intra-uterine 17. INDICATION(S) FOR USE Endometriosis DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 18-JAN-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) (cont.) þ 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 ( ): Endometriosis ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 08-JUN-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE 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...) die Symptome nun wieder aufgetreten sind. Vor Einsetzen der Hormonspirale bestanden die Unterleibsschmerzen aufgrund der Endometriose und aufgrund der Endometriose eine leichte Verschlechterung der psychischen Symptome. Jedoch sind die Nebenwirkungen erst kurze Zeit nach dem Einsetzen am wieder so stark geworden, obwohl sich an den restlichen Lebensumständen nichts geändert hat. Durch verschiedene Eigenrecherchen und Berichte habe ich erst herausgefunden, dass die Nebenwirkungen durch die Mirena Hormonspirale aufgetreten sind. Die Hormonspirale wurde von drei Gynäkologen als Mittel der Wahl zur Behandlung empfohlen. Mögliche Nebenwirkungen wurden nicht besprochen Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date Depression [MedDRA 20.0 PT ( ): Depression ] ( ): Depression ] Angstattacken [MedDRA 20.0 PT ( ): Anxiety ] ( ): Anxiety attack ] Gewichtszunahme [MedDRA 20.0 PT ( ): Weight increased ] ( ): Weight gain ] Unterleibsschmerzen [MedDRA 20.0 PT ( ): Abdominal pain lower ] ( ): Lower abdominal pain ] verminderte Libido [MedDRA 20.0 PT ( ): Libido decreased ] ( ): Libido decreased ] Erschöpfung [MedDRA 20.0 PT ( ): Fatigue ] ( ): Exhaustion ] * 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
3 Report Page: 3 of Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start date End date Duration Dose * Route(s) of Administration Indication(s) mirena 18-JAN A: B: C: D: E: Intra-uterine Endometriosis 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 levonorgestrel 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 20.0 ( ): Endometriosis ] Unknown Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM 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
4 Report Page: 4 of 5 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 Deutschland No 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? DE-CADRBFARM 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 85 Deutschland Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Deutschland Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 106 Height (cm) 161
5 Report Page: 5 of 5 Last menstrual periode date Text for relevant medical history and concurrent conditions Dauer der Behandlung: 14 0
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200992 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR Unterleibskrämpfe
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16252171 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 DA MO YR Female
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17056924 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 DA MO YR erhöhter
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16226405 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR DA MO YR Female
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17407687 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 27 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16272270 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 Female DA MO
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17278782 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 29 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16333916 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET (10019211): Headache ] grippeähnliche
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16287026 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 75 (Year) Female
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17069443 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 48 (Year) DA
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16372160 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 Extremer Schwindel
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17073011 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Lippentrockenheit (10024552):
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17190360 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 52 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17148488 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 DA MO YR Male
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16118335 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy starke Schwindelanfälle (10013582):
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17129488 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 22 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16394153 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 [ MedDRA 19.1
SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16390200 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 [ MedDRA 19.1
SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16390214 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR [ MedDRA 19.1 LLT
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17183946 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 [ MedDRA 20.0
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17289702 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 51 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17243762 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 DA MO YR Female
SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17379880 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 36 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17313976 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 48 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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SUSPECT ADVERSE REACTION REPORT
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