SUSPECT ADVERSE REACTION REPORT

Size: px
Start display at page:

Download "SUSPECT ADVERSE REACTION REPORT"

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 [ MedDRA 20.0 LLT ( ): Allergic exanthema ] 56 DA MO YR (Year) Male Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Unter erhöhten RR-Werten erfolgte die HA-Vorstellung mit Neueinstellung auf Amlodipin ab Es trat ein Palmarerythem neu auf- Annahme unsererseits dies kam vom Amlodipin, daher wurde dies wieder abgesetzt. Zeitgleich Cipralex-Eindosierung seit 11.5., weiter anhaltende Rötung der Hände, Cipralex wurde pausiert ab , das Erythem war abgeklungen. Reexposition am , erneute Rötung UA bds., Juckreiz und kl.pustelartige, nicht eitrige Erhebungen. Weiterbehandlung: Neueinstellung auf Venlafaxin ret. und Mirtazapin, depressive Symptomatik deutlich gebessert. 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT Sender's comment: 14. SUSPECT DRUG(S) (include generic name) cipralex II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 5 Mg milligram(s),1 Day 17. INDICATION(S) FOR USE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 11-MAY-2016 to 22-MAY Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) doxepin from 2012 galvus (cont.) þ 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 20.0 ( ): Depression ] Continuing: Unknown [ MedDRA 20.0 ( ): Hypertension arterial ] Continuing: Unknown [ MedDRA 20.0 ( ): Type 2 diabetes mellitus ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 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 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...) Ungewöhnliche Nebenwirkung: Benkert Hippius: Hautausschlag gelegentlich, aber Palmarerythem als solches nicht erwähnt, ggfs. Rückfrage beim Hersteller nötig, ob solches bekannt. Zusammenhang sicher, da Reexposition positiv => für Cipralex. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT ( ): Dermatitis allergic ] 9 Day recovered/resolved 18-MAY MAY-2016 [ MedDRA 20.0 LLT ( ): Allergic exanthema ] * 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 11-MAY-2016 GFR 2.64 ml/min 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of cipralex 11-MAY- 22-MAY- 12 Day A: C: 5Mg milligram(s) 8 Day 5 Day Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages

3 Report Page: 3 of 7 escitalopram oxalate Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Allergic exanthema ] AMSP certain 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of cipralex 25-MAY- 26-MAY- 2 Day A: C: 5Mg milligram(s) 8 Day 9 Day Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages escitalopram oxalate Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Allergic exanthema ] AMSP certain 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of doxepin 2012 A: C: 50Mg milligram(s)

4 Report Page: 4 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages doxepin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of galvus A: C: 50Mg milligram(s) Diabetes seit längerem

5 Report Page: 5 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages vildagliptin 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of amlodipin 18-MAY A: C: 5Mg milligram(s) Drug withdrawn Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages amlodipine 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Depression ] Unknown rezidivierend [ MedDRA 20.0 ( ): Hypertension arterial ] Unknown [ MedDRA 20.0 ( ): Type 2 diabetes mellitus ] Unknown [ MedDRA 20.0 ( ): Gambling addiction ] Unknown

6 Report Page: 6 of 7 Report duplicates Duplicate source AMSP - Institut für Arzneimittelsicherheit in der Duplicate number RUD ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents No List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? 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 15 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Fax Telephone address PATIENT INFORMATION (... continuation...)

7 Report Page: 7 of 7 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

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 information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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 information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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.

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT 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 information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION

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)

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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)

More information

SUSPECT ADVERSE REACTION REPORT

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):

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

GUIDELINE ON FILLING THE CIOMS FORM

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

More information

Serious Adverse Event (SAE) Form Clinical Trials

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

More information

SAE håndtering i protokol CC MM-001

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

More information

Serious Adverse Event (SAE) Form Clinical Trials

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

More information

adsm TB Version July 25 th, 2016

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

More information

Division of AIDS Safety Office EXPEDITED ADVERSE EVENT (EAE) Form

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

More information

Serious Adverse Event Report Form (CTIMP)

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

More information

Tocilizumab Guided Questionnaire Myocardial Infarction/Acute Coronary Syndrome

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

More information

PHARMACOVIGILANCE GLOSSARY

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

More information

ASSIGNED TREATMENT ARM

ASSIGNED 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 information

WELCOME TO ONLINE TRAINING FOR CLINICAL RESEARCH COORDINATORS

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

More information

Safety Manual: DAD Trial

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

More information

FDA - Adverse Event Reporting System (FAERS)

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

More information

TITLE: SAFE USE OF MEDICINES IN ZANZIBAR A

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

More information

Tocilizumab/Roactemra Guided Questionnaire Anaphylaxis/Serious hypersensitivity reaction

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 )

More information

Adverse Event Reporting. Good Clinical Practice

Adverse 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 information

Research & Development. J H Pacynko and J Illingworth. Research, pharmacy and R&D staff

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

More information

Safety Assessment in Clinical Trials and Beyond

Safety 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 information

GENERAL INFORMATION. Adverse Event (AE) Definition (ICH GUIDELINES E6 FOR GCP 1.2):

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

More information

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 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 information

Question 1: Has your doctor or health care professional told you that you had type 1 or type 2 diabetes?

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

More information

SUSPECT ADVERSE REACTION REPORT

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

More information

Compliance and Best Practices. 2. Quick regulatory review. 3. Global Cosmetics Vigilance diagram, example of in-house operational logogram

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

More information

Understanding Adverse Events

Understanding 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 information

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 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 information

Regulatory Aspects of Pharmacovigilance

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

More information

Adverse Event Reporting Programme for Veterinary Medicines

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

More information

Medication Errors a challenge of pharmacovigilance BfArM experience

Medication Errors a challenge of pharmacovigilance BfArM experience Medication Errors a challenge of pharmacovigilance BfArM experience Dr. Claudia Kayser Federal Institute for Drugs and Medical Devices Medication safety / Pharmacovigilance 1 Disclosure Statement X I have

More information

Register of Exercise Professionals (REPs) Application for Level 4 Registration Specialist Fitness Instructor - Supporting Evidence

Register of Exercise Professionals (REPs) Application for Level 4 Registration Specialist Fitness Instructor - Supporting Evidence Register of Exercise Professionals (REPs) Application for Level 4 Registration Specialist Fitness Instructor - Supporting Evidence Specialist Fitness Instructors at Level 4 on the Register of Exercise

More information