SUSPECT ADVERSE REACTION REPORT
|
|
|
- Lewis Ray
- 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 privacy DE DA MO YR 25 DA MO YR (Year) Male ( ): Basedow's disease ] ( ): Blood pressure increased ] Klinik einer Hyperthyreose, "Jod-Basedow-Effekt" bei topischer Anwendung von Povidon-Iod an frischen Piercings ( ): Hyperthyroidism ] ( ): Nervousness ] ( ): Heart racing ] ( ): Sleep disorder ] leichte Tachykardie ( ): Tachycardia ] ( ): Tremor ] ( ): Visual disturbance ] Druckgefühl hinter den Augen ( ): Sensation of pressure in eye ] Wärmeintoleranz ( ): Temperature intolerance ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Am unter aseptischen Bedingungen 3 Piercings (Helixknorpel, Septum nasi, Unterlippe) gestochen. Ab Wundantiseptik mit Betaisodona Lösung (Povidon-Iod 11%). An den 8-12 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.) betaisodona loesung (batch: ) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "An den ersten beiden Tagen 1/1/1 dann 1/0/1" Topical 17. INDICATION(S) FOR USE Skin disinfection 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 28-APR-2016 to 01-MAY-2016 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? þ YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.0 ( ): Primary hypothyroidism ] Continuing: [ MedDRA 19.0 ( ): Cosmetic body piercing ] Continuing: [ MedDRA 19.0 ( ): Smoker ] Continuing: Yes (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 20-MAY-2016 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...) ersten beiden Tagen dreimal täglich, dann zweimal täglich In der Nacht zum unruhiger Schlaf mit häufigem Hochschrecken und Herzrasen. Am Nervosität, Tremor, Wärmeintoleranz, subjektive Sehstörungen mit Druckgefühl hinter den Augen, leichte Tachykardie, RR 150/90. Betaisodona abgesetzt, auf iodfreies Präparat ausgewichen. Klinik einer Hyperthyreose, "Jod-Basedow-Effekt" bei topischer Anwendung von Povidon-Iod an frischen Piercings. Ergänzung: Wiederaufflammen nach experimenteller Reexposition. Spontanremission nach Präparatewechsel ->Antiseptik mit Octenidin fortgeführt. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date Klinik einer Hyperthyreose, "Jod-Basedow-Effekt" bei topischer Anwendung von Povidon-Iod an frischen Piercings [MedDRA 19.0 PT ( ): Hyperthyroidism ] ( ): Hyperthyroidism ] End date [MedDRA 19.0 PT ( ): Basedow's disease ] ( ): Basedow's disease ] [MedDRA 19.0 PT ( ): Sleep disorder ] ( ): Sleep disorder ] [MedDRA 19.0 PT ( ): Palpitations ] ( ): Heart racing ] [MedDRA 19.0 PT ( ): Nervousness ] ( ): Nervousness ] [MedDRA 19.0 PT ( ): Tremor ] ( ): Tremor ] Wärmeintoleranz [MedDRA 19.0 PT ( ): Temperature intolerance ] ( ): Temperature intolerance ] Druckgefühl hinter den Augen [MedDRA 19.0 PT ( ): Ocular discomfort ] ( ): Sensation of pressure in eye ] leichte Tachykardie [MedDRA 19.0 PT ( ): Tachycardia ] ( ): Tachycardia ]
3 Report Page: 3 of 5 [MedDRA 19.0 PT ( ): Blood pressure increased ] ( ): Blood pressure increased ] [MedDRA 19.0 PT ( ): Visual impairment ] ( ): Visual disturbance ] * 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 Blood pressure 150/90 mmhg 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) betaisodona loesung (batch: ) 28-APR Identification of the country where the drug was obtained 01-MAY A: An den ersten beiden Tagen 1/1/1 dann 1/0/1 B: C: D: E: Topical Skin disinfection Name of holder/applicant Mundipharma GmbH 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 Drug withdrawn 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 Yes Active drug substance name povidone-iodine
4 Report Page: 4 of Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 19.0 ( ): Primary hypothyroidism ] ohne vorbekannte Thyreoiditiden [ MedDRA 19.0 ( ): Cosmetic body piercing ] [ MedDRA 19.0 ( ): Smoker ] Yes [ MedDRA 19.0 ( ): Grass allergy ] Yes Gräserpollenallergie Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-PEI-WEBHUMAN_CONSUMER_ 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? 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 22 Consumer or other non health professional Consumer or other non health professional
5 Report Page: 5 of 5 SENDER INFORMATION (... continuation...) 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) 80 Height (cm) 174 Last menstrual periode date Text for relevant medical history and concurrent conditions
SUSPECT 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
SUSPECT 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):
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):
SUSPECT 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
SUSPECT 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)
SUSPECT 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
SUSPECT 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)
SUSPECT 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)
SUSPECT 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
SUSPECT 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)
SUSPECT 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):
SUSPECT 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
SUSPECT 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):
SUSPECT 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):
SUSPECT 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
SUSPECT 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)
SUSPECT 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
SUSPECT 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
SUSPECT 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):
SUSPECT 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)
SUSPECT 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
SUSPECT 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
SUSPECT 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.
SUSPECT 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):
SUSPECT 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):
SUSPECT 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
SUSPECT 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)
SUSPECT 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
SUSPECT 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)
SUSPECT 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)
þ 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):
SUSPECT 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
SUSPECT 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):
SUSPECT 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)
SUSPECT 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)
SUSPECT 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)
SUSPECT 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
SUSPECT 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
SUSPECT 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)
SUSPECT 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)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16186976 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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):
SUSPECT 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)
SUSPECT 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
SUSPECT 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
SUSPECT 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)
SUSPECT 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
SUSPECT 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
þ 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
þ 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)
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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
SUSPECT 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)
SUSPECT 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)
SUSPECT 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)
SUSPECT 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)
SUSPECT 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):
SUSPECT 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
GUIDELINE 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
SAE 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
Serious 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
Division 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
Serious 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
adsm 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
Serious 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
Safety 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
GENERAL 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
TITLE: 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
Manual 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...
PHARMACOVIGILANCE 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
FDA - 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
WELCOME 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
Compliance 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
Tocilizumab/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 )
Seeing Chickens at Window Recording Adverse Events and GeneratingQuality Data. Margaret Band, Clinical Trial Manager, TCTU
Seeing Chickens at Window Recording Adverse Events and GeneratingQuality Data Margaret Band, Clinical Trial Manager, TCTU Adverse Event Reporting Monitoring of adverse events (AEs) is critical to the patient
The 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,
Regulatory Aspects of Pharmacovigilance
Regulatory Aspects of Pharmacovigilance Deirdre Mc Carthy Pia Caduff-Janosa Training Course Uppsala 2013 Agenda Risk based approach to spontaneous reporting (incl clinical trials) -> Pia Caduff-Janosa
Research & Development. J H Pacynko and J Illingworth. Research, pharmacy and R&D staff
Department Title of SOP Research & Development Safety reporting SOP SOP reference no: R&D GCP SOP 07 Authors: Current version number and date: J H Pacynko and J Illingworth Version 9, 31.01.18 Next review
Question 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
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17249009 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
university sciences of Isfahan university Com
Introduce R. Gholamnezhad Lecturer of school of nursing & midwifery of Iran university Ph.D student tof Immunology, Sh School of medical sciences of Isfahan university E-Mail: Gholami278@gmail. Com Interpreting
THYROID AWARENESS. By: Karen Carbone. January is thyroid awareness month. At least 30 million Americans
THYROID AWARENESS By: Karen Carbone January is thyroid awareness month. At least 30 million Americans have a thyroid disorder and half-15 million-are silent sufferers who are undiagnosed, according to
SECTION 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
Synopsis Style Clinical Study Report SR EFC10139 Version number: 1 (electronic 2.0)
SYNOPSIS Title of the study: A randomized, double-blind, parallel-group, multicenter, multinational study to assess the long-term effect, over 1 year, of rimonabant 10 mg in comparison with rimonabant
Tocilizumab 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
REPORT INFORMATION. Report Profile. Report Identifying Information. Report Version. Voluntary Dietary Supplements Report FDA ICSR ID
REPORT INFORMATION Report Profile Report Version Report Category Submitted Voluntary Dietary Supplements Report 2014-09-24 10:29:28 EST FDA ICSR ID 1036202 Report Key for Followup Report Identifying Information
Adverse 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