SUSPECT ADVERSE REACTION REPORT
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- Richard Becke
- vor 7 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 DE DA MO YR 56 DA MO YR () Female Wortfindungsstörungen ( ): Anomia ] Bauchkrämpfe ( ): Cramp abdominal ] Erbrechen ( ): Vomiting ] Durchfall ( ): Diarrhea ] Halluzinationen ( ): Hallucination ] Magen-Darm-Beschwerden ( ): Stomach discomfort ] juckender entzündeter After ( ): Anus discomfort ] Gehstörungen ( ): Gait disturbance ] Erschöpfbarkeit ( ): Exhaustion ] ( ): Hair loss ] ( ): Incontinence of urine ] in beiden Händen ( ): Pain burning ] Konzentrationsstörung/Arbeitsgedächtnis ( ): Concentration impairment ] Muskelschmerzen im Rücken ( ): Muscle pain ] extreme Achillessehnenbeschwerden mit Gehstörungen ( ): Achilles tendon pain ] Ameisenlaufen an den Beinen - schubweise ( ): Formication ] Müdigkeit/extrem schnelle Erschöpfbarkeit ( ): Tiredness ] 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) 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.) ciprofloxacin 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "400 mg/d (+4,5 g/d)" Intravenous (not otherwise specified) 17. INDICATION(S) FOR USE Sepsis 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 08- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 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 19.1 ( ): Type I diabetes mellitus ] Continuing: [ MedDRA 19.1 ( ): Hashimoto's thyroiditis ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 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...) Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden Im Krankenhaus (ca. Tag 2-3) Halluzinationen/wässriger Durchfall, dann in normalen Gesprächen gehäuft Wortfindungsstörungen, Merkfähigkeit/Wiedergabefähigkeit von Gelesenem gestört. Nach Entlassung Sept/Okt. 4 Wo. lang kolikartige Oberbauchbeschwerden (Leber?), v. 4 Wo. erhebl. Haarausfall, inzw. begleitet von Konzentrations-/Merkfähigkeitsdefiziten (fortbestehend; sehr extrem im März 16). Ab v. 15 Muskelverspannungen im gesamten Rücken - fortbestehend mit Höhepunkt im April 16 (extrem bewegungseingeschränkt, m. unkontrolliertem Harnverlust). Schnelle nervl. Überforderung/Sensibilität (b. Gespr. im Bekannten-/Fam.-Kreis) m. Geräuschempfindlichkeit, Gedanken gehen vermehrt verloren/konzentrationsprobleme/einschränkungen des Arb.-Gedächtnisses - fortbestehend. Anfang 7/16 extrem starke Schmerzen im Fuß-/Sprunggelenks-/Fersenbein-/Achillessehnen-/Waden-/Schienbeinbereich bds (ziehen bis in die Knie), starke muskuläre Schmerzen im LWS/Gesäß/Oberschenkelbereich ziehend in beide Knie mit natürlich stark eingeschränkter Gehfähigkeit, Treppensteigen kaum mögl., Gefühl als würde jemand das Fleisch von den Knochen reißen; nach Ruhephase von ca. 6 Wo. ab Ende 9/16 etwas gebessert. Gehen weiterhin nur sehr langsam und Auftreten bedächtig mögl.! Gelegentlich Ameisenlaufen auf den Schienenbeinen. Gelegentlich (vor allem nachts) brennende Schmerzen in beiden Händen. - Kannte ich vor 8/2015 alles nicht! - Die gesundheitliche Beeinträchtigung durch die Reaktion IST immernoch schwerwiegend (s.u.)! Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Halluzinationen [MedDRA 19.1 PT ( ): Hallucination ] recovered/resolved ( ): Hallucination ] Konzentrationsstörung/Arbeitsgedächtnis [MedDRA 19.1 PT ( ): Disturbance in attention ] ( ): Concentration impairment ] Muskelschmerzen im Rücken [MedDRA 19.1 PT ( ): Myalgia ] NOV-2015 ( ): Muscle pain ] extreme Achillessehnenbeschwerden mit Gehstörungen [MedDRA 19.1 PT ( ): Tendon pain ] Month JUL-2016 ( ): Achilles tendon pain ] Magen-Darm-Beschwerden [MedDRA 19.1 PT ( ): Abdominal discomfort ] ( ): Stomach discomfort ] Ameisenlaufen an den Beinen - schubweise [MedDRA 19.1 PT ( ): Formication ] ( ): Formication ] FEB-2016
3 Report Page: 3 of 7 Müdigkeit/extrem schnelle Erschöpfbarkeit [MedDRA 19.1 PT ( ): Fatigue ] ( ): Tiredness ] juckender entzündeter After [MedDRA 19.1 PT ( ): Anorectal discomfort ] 8 Month recovered/resolved SEP-2015 ( ): Anus discomfort ] Wortfindungsstörungen [MedDRA 19.1 PT ( ): Aphasia ] recovered/resolved ( ): Anomia ] Bauchkrämpfe [MedDRA 19.1 PT ( ): Abdominal pain ] ( ): Cramp abdominal ] Erbrechen [MedDRA 19.1 PT ( ): Vomiting ] ( ): Vomiting ] Durchfall [MedDRA 19.1 PT ( ): Diarrhoea ] ( ): Diarrhea ] Gehstörungen [MedDRA 19.1 PT ( ): Gait disturbance ] Month JUL-2016 ( ): Gait disturbance ] Erschöpfbarkeit [MedDRA 19.1 PT ( ): Fatigue ] ( ): Exhaustion ] [MedDRA 19.1 PT ( ): Alopecia ] NOV-2015 ( ): Hair loss ] [MedDRA 19.1 PT ( ): Urinary incontinence ] NOV-2015 ( ): Incontinence of urine ]
4 Report Page: 4 of 7 in beiden Händen [MedDRA 19.1 PT ( ): Pain ] ( ): Pain burning ] * 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 rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) ciprofloxacin 08-AUG A: 400 mg/d (+4,5 g/d) B: C: D: E: Intravenous (not otherwise specified) Sepsis 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 ciprofloxacin 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) tazobac 08-AUG- A: 400 mg/d (+4,5 Intravenous (not Sepsis
5 Report Page: 5 of g/d) B: C: D: E: otherwise specified) 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 piperacillin sodium tazobactam sodium 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.1 ( ): Type I diabetes mellitus ] [ MedDRA 19.1 ( ): Hashimoto's thyroiditis ] Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM 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 Deutschland
6 Report Page: 6 of 7 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? DE-CADRBFARM 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 16 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) 108 Height (cm) 168 Last menstrual periode
7 Report Page: 7 of 7 Text for relevant medical history and concurrent conditions
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-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-17203133 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)
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-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-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-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-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
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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-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-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-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
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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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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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SUSPECT ADVERSE REACTION REPORT
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