SUSPECT ADVERSE REACTION REPORT
|
|
- Annis Flynn
- 6 years ago
- Views:
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 DA MO YR 38 DA MO YR (Year) Female ( ): Distention ] ( ): Joint pain ] ( ): Bone pain ] ( ): Dizziness ] "grippeartige Müdigkeit" ( ): Tiredness ] "Unfähigkeit aufzustehen" ( ): Movement disorder ] ( ): Phlebitis NOS ] ( ): Respiratory distress ] ( ): Facial swelling ] ( ): Ear noises ] ( ): Swelling of hands ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Telefonischer Bericht der Meldenden: Patientin mit metastasierendem Mamakarzinom, Metastasen in allen Organen. Verordnung von Lonquex aufgrund niedriger Leukozytenzahl bei Chemotherapie mit Abraxane (125 mg/m2), zusätzlich Lyrica (25 mg 1x tgl.) als Schmerzmitte. Erste Lonquex-lnjektion am h später grippeartiges Gefühl. 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) Lonquex 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "1 Spritze am " { 1 Df dosage form, 1 separate Subcutaneous dose } privacy 17. INDICATION(S) FOR USE Leukopenia DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 26-MAY-2016 to 26-MAY-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) lyrica daily dose: 25 Mg milligram(s) every Day (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 (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.0 ( ): Breast cancer metastatic ] Continuing: Yes (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...) Nach 48 Stunden Anschwellen von Gesicht und Händen, starke Atemnot (über 2 Tage, von der Patientin als schwerwiegend beschrieben), Gelenk- und Knochenschmerzen, Bewegungsstörungen (Unfähigkeit aufzustehen), Schwindel, Ohrensausen, Völlegefühl, Venenentzündung. Seit Einnahme von lbuprofen (600 mg), dadurch Abklingen der Bewegungsapparat-assoziierten Störungen. Ebenfalls abgeklungen ist die Gesichtsschwellung, Schwellung der Hände deutlich verbessert. Andere UAWs anhaltend. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End "grippeartige Müdigkeit" [MedDRA 19.0 PT ( ): Fatigue ] ( ): Tiredness ] 2 Day 2 Day 27-MAY-2016 [MedDRA 19.0 PT ( ): Swelling face ] ( ): Facial swelling ] 4 Day recovered/ [MedDRA 19.0 PT ( ): Peripheral swelling ] ( ): Swelling of hands ] [MedDRA 19.0 PT ( ): Respiratory distress ] ( ): Respiratory distress ] 2 Day recovered/ Yes, highlighted by the reporter, SERIOUS 29-MAY-2016 [MedDRA 19.0 PT ( ): Arthralgia ] ( ): Joint pain ] 4 Day recovered/ [MedDRA 19.0 PT ( ): Bone pain ] ( ): Bone pain ] 4 Day recovered/ [MedDRA 19.0 PT ( ): Dizziness ] ( ): Dizziness ] [MedDRA 19.0 PT ( ): Tinnitus ] ( ): Ear noises ] [MedDRA 19.0 PT ( ): Abdominal distension ] ( ): Distention ] [MedDRA 19.0 PT ( ): Phlebitis ]
3 Report Page: 3 of 6 ( ): Phlebitis NOS ] "Unfähigkeit aufzustehen" [MedDRA 19.0 PT ( ): Movement disorder ] ( ): Movement disorder ] Unknown MAY-2016 * 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 End Duration Dose * Route(s) of Administration Indication(s) Lonquex 26-MAY- 26-MAY A: 1 Spritze am B: C: 1Df dosage form D: 1 E: Subcutaneous Leukopenia 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 Indikation: Chemotherapie-induzierte Leukozytaemie 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 LIPEGFILGRASTIM 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...)
4 Report Page: 4 of 6 Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) lyrica A: daily dose: 25 Mg milligram(s) every Day B: C: 25Mg milligram(s) D: 1 E: 1Day Oral Pain management 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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name pregabalin Interacting Drug(s) and Dates of Administration (... continuation...) Interacting Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) abraxane A: B: C: 125mg/m2 milligram(s)/sq. meter D: E: Intravenous (not otherwise specified) Metastatic breast cancer 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)
5 Report Page: 5 of 6 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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name paclitaxel 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.0 ( ): Breast cancer metastatic ] Yes Metastasen in allen Organen 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 Yes 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 Yes Was the case medically confirmed, if not initially from health professional? 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 37 Consumer or other non health professional SENDER INFORMATION (... continuation...)
6 Report Page: 6 of 6 Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 62 Height (cm) 164 Last menstrual periode Text for relevant medical history and concurrent conditions
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17192278 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy [ MedDRA 20.0 LLT (10016821):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17089293 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 11 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17170175 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy starke Rötung der Wangen
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17221020 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 62 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200326 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Anaphylaxie Stufe II nach
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17359392 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE [ MedDRA 20.0 LLT (10013968):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16395978 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 38 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16432834 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 62 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17077431 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 84 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17233171 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10042646): Swallowing disorder
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT 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 63 DA MO YR (Year) Female 14 12
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17183830 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Blutung aus der Arteria brachialis
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17069317 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10028813): Nausea ] etwas
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16275990 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy [ MedDRA 19.0 LLT (10019727):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17099788 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16415004 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10007031): Calf pain ] (10043127):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17134359 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 (10024574): increased
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16320765 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10047634): Vitamin K (10025433):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17342269 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16222626 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy zunehmende Dyspnoe (10013968):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17193859 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 79 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17146522 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17410911 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 Milde diabetische
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17144825 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10010774): Constipation
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17162877 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET DA MO YR 63 DA MO YR (Year) Female
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17257795 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17131311 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 79 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16240186 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 (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17103967 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy [ MedDRA 19.1 LLT (10001507):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17315775 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR Libidoverlust (10024870):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17036788 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 69 DA MO YR (Year)
More informationþ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17012572 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy [ MedDRA 19.1 LLT (10019663):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16415045 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 Leukopenie (10024283):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17152663 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10002948): Aphasia ] linkshemisph.
More informationSUSPECT ADVERSE REACTION REPORT
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)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17060862 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 (10057363): Allergic
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17198655 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17183827 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10012671): Diabetic ketoacidosis
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16158593 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 25 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17188452 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 20.0 LLT
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17085373 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 67 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17379924 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 35 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17051756 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR (10011942): Debility
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16306260 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy polyneuropathische Schmerzen
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17219108 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10043913): Toe amputation
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17256072 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 46 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17188381 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17183810 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR Sturz unklarer Genese
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17318090 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17058924 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 79 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17215219 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16307825 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 erneutes Vorhofflattern
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17338368 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE [ MedDRA 20.0 LLT (10008641):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17248909 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 (10024378): Leukocytosis
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17188479 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 (10033557): Palpitations
More informationþ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17182698 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16274177 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 31 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17020170 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Lungenembolie rechter Unterlappen
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200374 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10049347): Cracked lips
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200253 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 49 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17326018 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 (10012218): Delirium
More informationþ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17012572 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 85 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17208046 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 82 (Year) massiver
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17411839 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 [ MeDRA 20.1
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17186825 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 82 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17182043 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
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17131307 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 65 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17174559 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 60 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17150181 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 66 DA MO YR (Year)
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR (10028606): Myocarditis ] (10024283):
More informationSUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16390235 I. REACTION INFORMATION 1. PATIENT INITIALS 1. COUNTRY 2. DATE OF BIRTH 2. AGE 3. SEX 4-6 REACTION ONSET privcy (10000059): Abdominl discomfort
More informationGUIDELINE ON FILLING THE CIOMS FORM
GUIDELINE ON FILLING THE CIOMS FORM (PLEASE NOTE: - USE SEPARATE CIOMS FORMS FOR EACH PATIENT.) I. UNDER SECTION I OF CIOMS FORM. REACTION INFORMATION Please fill appropriate details as described below
More informationSAE håndtering i protokol CC MM-001
SAE håndtering i protokol CC-92480-MM-001 An SAE is any AE occurring at any dose that: Results in death; Is life-threatening (ie, in the opinion of the Investigator, the subject is at immediate risk of
More informationDivision of AIDS Safety Office EXPEDITED ADVERSE EVENT (EAE) Form
To: DAIDS SAFETY OFFICE Division of AIDS Safety Office EXPEDITED ADVERSE EVENT (EAE) Form Sent by: Please type or print in English Fax: 1-800-275-7619 (USA) or + 1-301-897-1710 (International) Phone: 1-800-537-9979
More informationSerious Adverse Event (SAE) Form Clinical Trials
Protocol Code number: LP0162-1334 1. Trial information: Subject ID: Site No.: Country: Is this the initial report of an SAE or a follow-up? Initial Follow-up, follow up no. In which period of the trial
More informationadsm TB Version July 25 th, 2016
WHO central database for collection of safety data (AE and/or SAE) in the scope of adsm of anti-tb drugs Variables to be collected ID case number CONTR Case ID number Case identification number in national
More informationSerious Adverse Event (SAE) Form Clinical Trials
Protocol Code number: LP0162-1325 1. Trial information: Subject ID: Site No.: Country: If blinded trial, was the study treatment unblinded? Yes No Is this the initial report of an SAE or a follow-up? Initial
More informationSerious Adverse Event Report Form (CTIMP)
SAE Identifier: Serious Adverse Event Report Form (CTIMP) Form completion instructions overleaf 1. Report type (tick one) Initial report Follow-up information 2. Site name: 3. Participant details Study
More informationSafety Manual: DAD Trial
Safety Manual: DAD Trial Cognitive behavioural therapy vs. sertraline in patients with depression and poorly controlled diabetes mellitus: A randomized controlled trial Short title: Diabetes and Depression
More informationGENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2):
Make copies of the blank SAE report form as needed. Retain originals with confirmation of all information faxed to DMID Pharmacovigilance Group Clinical Research Operations and Management Support (CROMS
More informationTITLE: SAFE USE OF MEDICINES IN ZANZIBAR A
Table of content Acknowledgements Introduction TITLE: SAFE USE OF MEDICINES IN ZANZIBAR A guide for health professionals in detecting and reporting adverse drug reaction. (Beautiful photograph tablets
More informationTocilizumab/Roactemra Guided Questionnaire Anaphylaxis/Serious hypersensitivity reaction
Tocilizumab/Roactemra Guided Questionnaire Anaphylaxis/Serious hypersensitivity reaction AER: Site : Local Case ID: Patient Date of Birth Patient ID/Initials: Patient Gender: M F Tocilizumab (Actemra )
More informationAdverse events following immunisation (AEFI) with 2010/2011 seasonal influenza vaccines
Adverse events following immunisation (AEFI) with 00/0 seasonal influenza vaccines Netherlands Pharmacovigilance Centre Lareb 8 juli 0 Goudsbloemvallei 7 57 MH s-hertogenbosch www.lareb.nl info@lareb.nl
More informationWELCOME TO ONLINE TRAINING FOR CLINICAL RESEARCH COORDINATORS
UCLA CTSI WELCOME TO ONLINE TRAINING FOR CLINICAL RESEARCH COORDINATORS ROLE OF THE RESEARCH COORDINATOR Adverse Events in Clinical Trials: Definitions and Documentation May 2016 Objectives Recognize the
More informationTocilizumab Guided Questionnaire Myocardial Infarction/Acute Coronary Syndrome
Tocilizumab Guided Questionnaire Myocardial Infarction/Acute Coronary Syndrome AER: Site : Local Case ID: Patient Date of Birth (dd-mmm-yyyy): Patient ID/Initials: Patient Gender: M F Patient Weight kg
More informationFDA - Adverse Event Reporting System (FAERS)
Case Information: Case Type: EXPEDITED (5- DAY) esub: Y HP: Country: USA Outcomes: DE, (A)NDA/BLA: 08936 / FDA Rcvd Date: 09-Oct-204 Mfr Rcvd Date: 08-Oct-204 Mfr Control : GB-ELI_LILLY_AND_COMPANY-US890360A
More informationSECTION OF NEUROSURGERY PATIENT INFORMATION SHEET
SECTION OF NEUROSURGERY PATIENT INFORMATION SHEET EC#: (for office use only) Patient s Name: Today s Date: Age: Date of Birth: Height: Weight: Physician you are seeing today: Marital Status: Married Work
More informationPHARMACOVIGILANCE GLOSSARY
PHARMACOVIGILANCE GLOSSARY Section 1 Section 2 Section 3 Section 4 Definitions of terminology used for side effects Definitions of drug safety terms Definitions of risk terminology Definitions of general
More informationTocilizumab Guided Questionnaire Gastrointestinal Perforation and Related Events
Tocilizumab Guided Questionnaire Gastrointestinal Perforation and Related Events AER: Site : Local Case ID: Patient Date of Birth (dd-mmm-yyyy): Patient ID/Initials: Patient Gender: M F Patient Weight
More informationManual for Expedited Reporting of Adverse Events to DAIDS Version 2.0 January 2010
Manual for Expedited Reporting of Adverse Events to DAIDS Version 2.0 January 2010 January 2010 Version 2.0 Table of Contents 1. INTRODUCTION...1 1.1 Scope... 1 1.2 Purpose... 1 1.3 Responsibilities...
More informationAdverse Event Reporting Programme for Veterinary Medicines
Adverse Event Reporting Programme for Veterinary Medicines ACVM guideline for registrants 1. Introduction 2. Statutory basis for adverse event reporting 3. Definitions 4. Statutory obligations 5. Information
More informationThe views expressed here are of those of the author and do not reflect official policies or positions of any agency
Use It Right Away LING CHIN, MD, MPH President and Medical Director GDU Clinical Trials Consulting, LLC Previous: Head of Safety and Pharmacovigilance, NIAID/DAIDS Chief, Clinical and Translational Research,
More informationSponsor / Company: Sanofi Drug substance(s): SAR (iniparib)
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):
More informationCompliance and Best Practices. 2. Quick regulatory review. 3. Global Cosmetics Vigilance diagram, example of in-house operational logogram
Personal Care Products Council Safety seminar Oct. 27, 2011 Cosmetics Vigilance in the EU www.iris-vigilance.com Compliance and Best Practices 1. Introducing IRIS 2. Quick regulatory review 3. Global Cosmetics
More informationPATIENT AUTHORIZATION AND NOTICE OF RELEASE OF INFORMATION (PAN)
XOLAIR Access Solutions is a free program for you from Genentech. We work to help you pay for your XOLAIR (omalizumab) for subcutaneous use. We can help in many different ways. We assist people who have
More informationQuestion 1: Has your doctor or health care professional told you that you had type 1 or type 2 diabetes?
DIABETES - Questions list Question 1: Has your doctor or health care professional told you that you had type 1 or type 2 diabetes? Type 1 diabetes Type 2 diabetes Neither Routing rule: ( Type 1 Diabetes->2
More informationPPHSN Reporting Form Severe acute respiratory syndrome (SARS) outbreak
ANNEX 2 PPHSN Reporting Form Severe acute respiratory syndrome (SARS) outbreak (updated 09.05.2003) PPHSN Reporting Form Severe acute respiratory syndrome (SARS) outbreak Report of suspected or probable
More informationHuman Papillomavirus Immunisation Programme. Background
Human Papillomavirus Immunisation Programme Background Recommending the use of a human papillomavirus (HPV) vaccine was first signalled in the New Zealand Cancer Control Strategy Action Plan 2005-2010.
More informationDEMOGRAPHICS PHYSICAL ATTRIBUTES VITAL SIGNS. Protocol: ABC-123 SCREENING. Subject ID. Subject Initials. Visit Date: / / [ YYYY/MM/DD]
SCREENING Visit Date: DEMOGRAPHICS / / [YYYY/MM/DD] Consent Signed Date and time / / [YYYY/MM/DD] : Has written assent been obtained? If no, why not? YES NO Gender: Male Female Birthdate: Permission given
More informationOphthalmologist/Optometrist/Low Vision Clinic Report. 1.1 Title: (Mr/Mrs/Miss, etc) Surname: Full Names:. 1.4 Physical Address:.
OPTIMA COLLEGE COMPUTER SKILLS PROGRAMME APPLICATION FORM PLEASE NOTE: Incomplete applications will not be considered. Please ensure that the following are attached: Medical Report Ophthalmologist/Optometrist/Low
More information