SUSPECT ADVERSE REACTION REPORT
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- Alfred Thornton
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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 Blutung aus der Arteria brachialis links [ MedDRA 20.0 LLT ( ): Arterial bleeding ] ausgeprägtes Hämatom linker Arm [ MedDRA 20.0 LLT ( ): Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Verlauf: Hämatomausräumung Results of tests and procedures relevant to the investigation of the patient: Hb Abfall 13.3 auf 9.9 g/dl DE DA MO YR 91 DA MO YR (Year) Female CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) 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.) xarelto 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION 15 Mg milligram(s),1 Day Oral 17. INDICATION(S) FOR USE Atrial fibrillation 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 06-MAR- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 ( ): Stent placement ] from 03-MAR- Continuing: [ MedDRA 20.0 ( ): Decompensated heart failure ] from 02-MAR- Continuing: Unknown [ MedDRA 20.0 ( ): Coronary disease ] Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 18-MAY- DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Outcome* Term highlighted Time interval 1** Time interval 2*** Start End Blutung aus der Arteria brachialis links [MedDRA 20.0 PT ( ): Arterial haemorrhage ] not recovered/not resolved 08-MAY- [ MedDRA 20.0 LLT ( ): Arterial bleeding ] ausgeprägtes Hämatom linker Arm [MedDRA 20.0 PT ( ): not recovered/not resolved 08-MAY- [ MedDRA 20.0 LLT ( ): * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit Normal low range Normal high range More inform. available Hemoglobin low erniedrigt/decrease d g/dl 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) xarelto 06-MAR- A: B: C: 15Mg milligram(s) D: E: 1Day Oral Atrial fibrillation Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Dose not changed Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number
3 Report Page: 3 of 5 D: Number of separate dosages E: Number of units in the interval Active drug substance name rivaroxaban Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Arterial bleeding ] [ MedDRA 20.0 ( ): 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Dose * Route(s) of Administration Indication(s) plavix 06-MAR- A: B: C: 75Mg milligram(s) D: E: 1Day Oral Stent placement Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Dose not changed Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name clopidogrel sulfate Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Arterial bleeding ] [ MedDRA 20.0 ( ):
4 Report Page: 4 of Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 20.0 ( ): Stent placement ] 03-MAR- [ MedDRA 20.0 ( ): Decompensated heart failure ] 02-MAR- Unknown Z.n. Stent global dekompensierte Myokardinsuffizienz [ MedDRA 20.0 ( ): Coronary disease ] [ MedDRA 20.0 ( ): Aortic valve disease mixed ] kombiniertes Aortenvitium mit führender Stenose [ MedDRA 20.0 ( ): Hypertension arterial ] [ MedDRA 20.0 ( ): Diabetes mellitus ] 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 0518 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 55 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country
5 Report Page: 5 of 5 Fax Telephone address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >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-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-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-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-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-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 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-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-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-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-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-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-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-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-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)
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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 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
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-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-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-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-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-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-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-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-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-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)
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-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-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-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-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
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-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-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
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-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)
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
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-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-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-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-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-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-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-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-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-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
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