SUSPECT ADVERSE REACTION REPORT
|
|
- Patience Melissa Doyle
- 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 DA MO YR [ MedDRA 20.0 LLT ( ): [ MedDRA 20.0 LLT ( ): 36 DA MO YR (Year) Male Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Genaue Beschreibung der UAW-Syniptomatik: Ab dem fiel der junge Patient mit Tachykardie, Dyspnoe, erheblichem Herzstechen und febrilen Temperaturen bis maximal 39,5 C auf. Die Fokussuche ergab kein Korrelat, weitere Beschwerden beklagte der Patient nicht. Maßnahmen nach der UAW: Absetzen;Verlegung;Konsil;Diagnostik Absetzen von Clozapin; Verlegung: Innere Medizin am ; Internistisches Konsil und Diagnostik: Zur Fokussuche erfolgten Blutkulturen, Urinkultur, Röntgen Thorax ohne Fokus, Echokardiographie ohne sicheren Myokarditis/okarditishinweis; EKG (intern ausgewertet) : SR, 80/min., LT, inkompl. RSB/ R/S in V4, keine ERBS; EKG vom 6.4.: SR 107/min. LT, R/S in V4 PNS, keine ERBS, das erhöhte Troponin und pro-nt-bnp wurden als Karditishinweis gewertet. 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) clozapin 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 25 Mg,1 Day 17. INDICATION(S) FOR USE DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 23-MAR-2016 to 24-MAR Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) zyprexa from 2013 to 22-MAR-2016 zyprexa from 23-MAR-2016 to (cont.) þ 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 DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 ( ): Paranoid schizophrenia ] (cont.) IV. SENDER INFORMATION 24a. ME AND ADRESS OF SENDER Hannover, DE 24c. DATE RECEIVED BY MANUFACTURER 13-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIOL þ INITIAL FOLLOW UP FIL (Cont.) = Continuation on attached sheet(s)
2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reporter's comments: Verlauf: UAW abgeklungen Weiterbehandlung: Risperidon, später Olanzapin (Zypadhera) und Glianimon. Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT ( ): 10 Day recovered/resolved 03-APR APR-2016 [ MedDRA 20.0 LLT ( ): [MedDRA 20.0 PT ( ): 10 Day recovered/resolved 03-APR APR-2016 [ MedDRA 20.0 LLT ( ): * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** and start of reaction/event Results of tests Date Test Result Unit Normal low range Normal high range More inform. available Leucocyte count 12.3 max. Wert /nl C-reactive protein 261 max. Wert mg/l Pulse rate 121 max. Wert /min. Body temperature 39.6 max. Wert C Troponin T max. Wert µg/l NT-proBNP 3260 max. Wert ng/l Blood culture - Urine culture - Chest X-ray - Echocardiography - 18-MAR-2016 ECG 18-MAR-2016 Sinus rhythm 80 /min 06-APR-2016 ECG 06-APR-2016 Sinus rhythm 107 /min 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 23-MAR- 24-MAR- 2 Day A:
3 Report Page: 3 of C: 25Mg Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): [ MedDRA 20.0 ( ): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 25-MAR- 26-MAR- 2 Day A: C: 50Mg
4 Report Page: 4 of 9 Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): [ MedDRA 20.0 ( ): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 26-MAR- 28-MAR- 3 Day A: C: 100Mg
5 Report Page: 5 of 9 Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): [ MedDRA 20.0 ( ): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Dose * Route(s) of clozapin 29-MAR- 05-APR Day A: C: 150Mg Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number clozapine Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ):
6 Report Page: 6 of 9 [ MedDRA 20.0 ( ): 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of zyprexa MAR Cululative dose number (to first reaction) C: Structure of separate dosages A: C: 25Mg olanzapine 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of zyprexa 23-MAR- 08-APR Day A: C: 10Mg
7 Report Page: 7 of 9 Cululative dose number (to first reaction) C: Structure of separate dosages olanzapine 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Dose * Route(s) of risperidon MAR A: C: 6Mg Cululative dose number (to first reaction) C: Structure of separate dosages risperidone 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...)
8 Report Page: 8 of 9 Concomitant Drug Dose * Route(s) of risperidon 25-MAR A: C: 8Mg Cululative dose number (to first reaction) C: Structure of separate dosages risperidone 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Paranoid schizophrenia ] F20.0 Report duplicates Duplicate source der Duplicate number SLF ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Yes
9 Report Page: 9 of 9 Additional documents 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 07 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Hannover Postcode Country Fax Telephone address PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) Height (cm) Last menstrual periode Text for relevant medical history and concurrent conditions
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):
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 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-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-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-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-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-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-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-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-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-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 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-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 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 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-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-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 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-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
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-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-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 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-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-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-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-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-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-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-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-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-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-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 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-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-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-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 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 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 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 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 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 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 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 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 informationSeeing 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
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 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 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 informationMedDRA Coding Quality: How to Avoid Common Pitfalls
MedDRA Coding Quality: How to Avoid Common Pitfalls Patricia Mozzicato, MD Chief Medical Officer MedDRA MSSO Disclaimer The views and opinions expressed in the following PowerPoint slides are those of
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 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 informationUnderstanding Adverse Events
The Fundamentals of International Clinical Research Workshop Understanding Adverse Events Deborah Hilgenberg Family Health International Goals of the Presentation Definition of Adverse Event (AE) Definitions
More informationAdverse Event Reporting. Good Clinical Practice
Adverse Event Reporting Good Clinical Practice Definitions and IMP Information The Elfin Dossier describes the physical and chemical, toxicological pharmacological data on an IMP No overt toxicity is expected
More informationSafety Assessment in Clinical Trials and Beyond
Safety Assessment in Clinical Trials and Beyond Yuliya Yasinskaya, MD Medical Team Leader Division of Anti-Infective Products Center for Drug Evaluation and Research FDA Clinical Investigator Training
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 informationResearch & 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
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 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 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 informationRegulatory 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
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 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 informationMedical Examination Form Seafarers
Please indicate with an X whether this examination is for an STCW or a national certificate of competency or proficiency: STCW (issued in accordance with STCW regulation I/9 National by an approved medical
More informationASSIGNED TREATMENT ARM
SF Radiation Therapy Oncology Group Phase III Lung High-dose vs Standard-dose Conformal XRT with Chemotherapy Consolidation Treatment Summary Form RTOG Study No. 0617 Case # AMENDED DATA YES INSTRUCTIONS:
More informationREPORT OF TRANSFUSION ADVERSE REACTION TO BLOOD CENTERS
REPORT OF TRANSFUSION ADVERSE REACTION TO BLOOD CENTERS INSTRUCTIONS: Send the form to ALL blood centers that provided blood components to this patient. Timely reporting is important, so that, if appropriate,
More information