SUSPECT ADVERSE REACTION REPORT
|
|
|
- Randolf Horton
- 6 years ago
- Views:
Transcription
1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR [ MedDRA 20.0 LLT ( ): Thrombopenia ] [ MedDRA 20.0 LLT ( ): Tarry stools ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: : Schilddrüse (FT4): 2,20 n; Elektrophorese GE 6,01 ; Albumin 51,0 ; gamma Globuline 27, : Elektrophorese GE 6,04 Results of tests and procedures relevant to the investigation of the patient: 77 DA MO YR (Year) Male CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED þ INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT EKG bei Aufnahme: Normofrequentes Vorhofflimmern 91/mm, Linkstyp, R/S-Umschlag V3, V4. Dezent descendierende ST-Strecke V4 bis V6 mit T-Negativierung. 14. SUSPECT DRUG(S) (include generic name) eliquis 2,5 II. SUSPECT DRUG(S) INFORMATION 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 5 Mg every Day" { 2.5 Mg, 2 in 1 Day } 17. INDICATION(S) FOR USE Atrial fibrillation 18. THERAPY DATES (from/to) 19. THERAPY DURATION 4 Year III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) actraphane 30/70 daily dose: 40 Iu international unit(s) every Day amlodipin 10 daily dose: 10 Mg every Day (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 ( ): Renal insufficiency ] Continuing: Unknown [ MedDRA 20.0 ( ): Diastolic heart failure ] Continuing: Unknown [ MedDRA 20.0 ( ): Type II diabetes mellitus ] Continuing: Unknown (cont.) IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER Berlin, DE 24c. DATE RECEIVED BY MANUFACTURER 21-SEP-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...) Blutzuckertagesprofil vom : m. Labor Bioscentia XY: Nasenabstrich vom : Staphylococcus aureus massenhaft. Thrombozytenserologie: HLA-Klasse 1- lgg Ak negativ. Blutausstrich mikroskopisch: deutlich verminderte Thrombozytenzahl, keine Aggregation im Ausstrich sichtbar. Thrombozyten-Ak, freie im Serum: GP llb/llla-ak negativ. GP lb/lx-ak negativ. GP la/ila-ak negativ. Thrombozyten-Ak, gebunden (EB): GP-Ak gebunden: negativ Differentialblutbild: Leukozyten 8,9/nl (3,7-10,1), Erythrozyten 3,2/pl (4,1-5,7), Hämoglobin 8,9 (13,1-16,8), Hämatokrit 0,26 l/l (0,38-0,49), MCV 81 fl (81-99), 28 (27-34), C 34 (32-36), Thrombozyten 33/nl ( ); Basophile 0 (bis 2), Eosinophile 0 (1-7), Segmentkemige 87 (40-70), Stabkernige 0 (1-10), Lymphozyten 13 (18-45), Monozyten 0 (3-10), Anulozyten + Dakrozyten (EB) + Elliptozyten ++ Makrozyten (EB) + Mikrozyten (EB) + Normoblasten 6/1 00 Leukos, Poikilozytose ++ Riesenthrombozyten +++ Stechapfelzellen ++. Röntgen Thorax im Liegen ap vom : Zwerchfell bds. glatt begrenzt, trotz liegender Aufnahme sicher biventrikulär verbreitertes Herz, beginnende pulmonale Stauung. Aortensklerose. Keine lnfiltrate oder Rundherde. Oberes Mediastinum wahrscheinlich aufnahmetechnisch verbreitert. Sonographie Abdomen vom : Orientierend bei eingeschränkter Sicht: Von intercostal Leber unauff., GB wohl steinfrei. Nieren bds. parenchymverschmälert, ungestaut. Cava dilatiert, Aorta normweit. keine freie Flüssigkeit. Keine PEs im Liegen. Sonographie Abdomen vom : Schlechte Schallbarkeit bei deutlichem Meteorismus. Keine freie Flüssigkeit keine PE. Leberrand leicht wellig, Struktur inhomogen. GB klein. Gallenwege nicht dilatiert. Mhz grenzwertig,12 cm. UES. Reporter's comments: Maßnahme: Thrombozytenkonzentrate (2x) und Erythrozytenkonzentrate (2x). Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** [MedDRA 20.0 PT ( ): Thrombocytopenia ] recovering/resolving [ MedDRA 20.0 LLT ( ): Thrombopenia ] [MedDRA 20.0 PT ( ): Melaena ] recovering/resolving [ MedDRA 20.0 LLT ( ): Tarry stools ] * 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 1.42 m GFR 51 NA JUN JUN JUN
3 Report Page: 3 of Urea 69 m Urea 72 m 28-JUN-2017 Urea 41 m 1.44 m 1.40 m Potassium 3.39 mmol/l Potassium 3.34 mmol/l Uric acid m 28-JUN-2017 Uric acid m 22-JUN JUN JUN JUN-2017 Haematocrit 28.9 Haematocrit JUN-2017 Haematocrit JUN-2017 Haematocrit JUN JUN JUN C JUN-2017 C JUN-2017 C JUN-2017 Lymphocyte count JUN-2017 Monocyte count 11.2 Bilirubin total 1.65 m Urea 159 m Urea 184 m 1.76 m 1.62 m 1.87 m Sodium 148 mmol/l Sodium 149 mmol/l Sodium 146 mmol/l
4 Report Page: 4 of 13 Albumin 3.0 C-reactive protein 8.3 mg/l C-reactive protein 7.5 mg/l Quick's test 43 Quick's test 49 Quick's test 61 INR 1.76 NA INR 1.61 NA INR 1.37 NA INR 1.23 NA Haematocrit 28.6 Haematocrit 26.3 Haematocrit 27.8 Haematocrit 25.3 Haematocrit 25.1 Haematocrit
5 Report Page: 5 of C 31.2 C 30.8 C 31.7 C 31.6 C 31.1 C 31.0 Neutrophil count 79.4 Lymphocyte count 12.6 Reticulocyte count 18 o/oo TSH 0.01 µu/ml Glucose 225 m Glucose 239 m Glucose 202 m Glucose 220 m Glucose 231 m Urea 181 m 1.71 m 8.9 Haematocrit C Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of eliquis 2,5 4 Year A: daily dose: 5 Mg every Day C: 2.5Mg D: 2 Atrial fibrillation
6 Report Page: 6 of 13 Drug withdrawn Additional information on drug Cumulative dose number (to first reaction) C: Structure dosages number apixaban Causality assessment Reaction Source Method Result [ MedDRA 20.0 ( ): Thrombopenia ] AkdÄ Global Introspection (WHO GI) conditional/unclassifie d 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) actraphane 30/70 A: daily dose: 40 Iu Subcutaneous international unit(s) every Day C: 40Iu international unit(s) D: 1
7 Report Page: 7 of 13 Additional information on drug Cululative dose number (to first reaction) insulin human injection, isophane 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) amlodipin 10 A: daily dose: 10 Mg every Day C: 10Mg D: 1 Additional information on drug Cululative dose number (to first reaction) amlodipine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) benazepril 20 A: daily dose: 20 Mg every Day C: 20Mg D: 1
8 Report Page: 8 of 13 Additional information on drug Cululative dose number (to first reaction) benazepril 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) tamsulosin 0,4 A: daily dose: 0.4 Mg every 2 Day C: 0.4Mg D: 1 E: 2Day Additional information on drug 1-0-0
9 Report Page: 9 of 13 Cululative dose number (to first reaction) tamsulosin 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) carvedilol 25 A: daily dose: 50 Mg every Day C: 25Mg D: 2 Additional information on drug Cululative dose number (to first reaction) carvedilol 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) moxonidin 0,3 A: daily dose: 0.3 Mg every Day C: 0.3Mg D: 1
10 Report Page: 10 of 13 Additional information on drug Cululative dose number (to first reaction) moxonidine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) pantoprazol 40 A: daily dose: 40 Mg every Day C: 40Mg D: 1 Additional information on drug 1-0-0
11 Report Page: 11 of 13 Cululative dose number (to first reaction) pantoprazole 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 ( ): Renal insufficiency ] Unknown [ MedDRA 20.0 ( ): Diastolic heart failure ] Unknown chronisch diastolische Herzinsuffizienz [ MedDRA 20.0 ( ): Type II diabetes mellitus ] Unknown Diabetes mellitus Typ 2 (Insulin) [ MedDRA 20.0 ( ): Diabetic nephropathy ] Unknown Diabetes mellitus Typ 2 (Insulin) mit diabetischer Nephropathie [ MedDRA 20.0 ( ): Double vessel disease ] Unknown Koronare 2-Gefäßerkrankung mit PTCA und Bare metal stent Implantation 05/2011 in die proximale RCA u [ MedDRA 20.0 ( ): Hypertension arterial ] Unknown [ MedDRA 20.0 ( ): Bypass surgery ] DEC [ MedDRA 20.0 ( ): Apoplexy ] NOV [ MedDRA 20.0 ( ): Hemiparesis (right) ] NOV [ MedDRA 20.0 ( ): Dysarthrophonia ] NOV Unknown Unknown Unknown Unknown Z. n. popliteo-pedalem Venenbypass rechts 12/2009 Z. n. Apoplex links mit Hemiparese rechts und Dysarthrophonie 11/2009 Z. n. Apoplex links mit Hemiparese rechts und Dysarthrophonie 11/2009 Z. n. Apoplex links mit Hemiparese rechts und Dysarthrophonie 11/2009 [ MedDRA 20.0 ( ): Hyperthyroidism ] Unknown Manifeste Hyperthyreose bei bekanntem multiplen fokalen Autonomien [ MedDRA 20.0 ( ): Antral gastritis ] NOV [ MedDRA 20.0 ( ): Duodenal ulcer ] NOV Unknown Unknown Z. n. erosiver Antrumgastritis und Ulcus duodeni mit Hämatemesis 11/2011 Z. n. Ulcus duodeni mit Hämatemesis 11/2011 [ MedDRA 20.0 ( ): Haematemesis ] NOV Unknown Z. n. Hämatemesis 11/2011 [ MedDRA 20.0 ( ): Non-smoker ] Unknown [ MedDRA 20.0 ( ): Adiposis ] Unknown adipöser Ernährungszustand. Gewicht 114 kg, bei Entlassung 107 kg [ MedDRA 20.0 ( ): Leg oedema ] Unknown deutliche Ödeme bds. [ MedDRA 20.0 ( ): Dermatosis ] Unknown Stauungsdermatose bds.
12 Report Page: 12 of 13 [ MedDRA 20.0 ( ): Haematoma ] Unknown kleinere multiple Hämatome an den Armen [ MedDRA 20.0 ( ): Dental prosthesis wearer ] Unknown Oberkieferprothese [ MedDRA 20.0 ( ): site haematoma ] Unknown Hämatome im Unterbauch vom Insulinspritzen [ MedDRA 20.0 ( ): Generalized arteriosclerosis ] Unknown schwerste generalisierte Arteriosklerose/Beine [ MedDRA 20.0 ( ): Bronchitis ] Unknown Report duplicates Duplicate source Arzneimittelkommission der Deutschen Ärzteschaft, Duplicate number DE-DCGMA de-dcgma Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code pradaxa [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 ( ): Epistaxis ] JAN simva [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (0): unbekannt ] torem 50 [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (0): unbekannt ] torem 20 [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (0): unbekannt ] ferro-sanol [ MedDRA 20.0 (0): unbekannt ] [ MedDRA 20.0 (0): unbekannt ] Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 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 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Yes Yes medical and laboratory report Yes Regulatory authority's case report number Other case identifiers in previous transmissions Yes Yes
13 Report Page: 13 of 13 Was the case medically confirmed, if not initially from health professional? 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 95 Physician SENDER INFORMATION (... continuation...) Type Organisation Health professional Department Street address City Berlin Postcode Country Fax +49 / (0) / Telephone +49 / (0) / address phv@akdae.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 107 Height (cm) 170 Last menstrual periode Text for relevant medical history and concurrent conditions Diagnosen: - Teerstuhl, am ehesten im Rahmen einer diffusen GI-Blutung bei Thrombopenie unter Eliquis bei permanentem Vorhofflimmern - Z. n. Epistaxis unter Pradaxa 01/ Cardiale Dekompensation im Rahmen des Blutverlustes bei chronisch diastolischer Herzinsuffizienz - Transfusion von insgesamt zwei Erythrozytenkonzentraten und zwei Thrombozytenkonzentraten - Koronare 2-Gefäßerkrankung mit PTCA und Bare metal stent Implantation 05/2011 in die proximale RCA und med. LAD - Cardiovaskuläre Risikofaktoren: - Arterielle Hypertonie - Diabetes mellitus Typ 2 (Insulin) mit diabetischer Nephropathie - Z. n. popliteo-pedalem Venenbypass rechts 12/ Z. n. Apoplex links mit Hemiparese rechts und Dysarthrophonie 11/ Manifeste Hyperthyreose bei bekanntem multiplen fokalen Autonomien - Z. n. erosiver Antrumgastritis und Ulcus duodeni mit Hämatemesis 11/2011 keine Allergien bekannt Patient lebt mit Ehefrau in Häuslichkeit. Diakonie kommt zum lnsulinspritzen 1x täglich, Pflegegrad III besteht. Kein Nikotin, kein Alkohol. 1 x Nykturie, Stuhigang sonst unauffällig.
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):
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-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-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-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-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-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-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-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-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-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-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-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-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-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
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-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-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-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-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-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-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-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-17183830 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy Blutung aus der Arteria brachialis
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-17318090 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR [ MedDRA 20.0
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-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-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-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-17131307 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 65 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-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-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-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 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 63 DA MO YR (Year) Female 14 12
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17144825 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy (10010774): Constipation
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-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-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-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-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-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-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-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-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-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-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-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-17182043 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR [ MedDRA 20.0
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-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-17186825 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 82 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17174559 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 60 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17150181 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 66 DA MO YR (Year)
SUSPECT ADVERSE REACTION REPORT
CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-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
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):
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
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
SAE håndtering i protokol CC MM-001
SAE håndtering i protokol CC-92480-MM-001 An SAE is any AE occurring at any dose that: Results in death; Is life-threatening (ie, in the opinion of the Investigator, the subject is at immediate risk of
Serious Adverse Event (SAE) Form Clinical Trials
Protocol Code number: LP0162-1325 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
Basel IX: First Insights «Let s get to the heart of the matter» Patrick Badertscher Research Lunch,
Basel IX: First Insights «Let s get to the heart of the matter» Patrick Badertscher 74-jährig, männlich, synkopiert Jetziges Leiden Zuweisung mit der Sanität Plötzlich schwarz vor Augen in der Dusche,
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
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
Hamilton Regional Laboratory Medicine Program
Created: April 2002 of Review: February 2004 of Review: June 2006 of Review: July 2007, St. Joseph s Healthcare went live with Meditech as of June18, 2007. of Review: August 2009 of Review: December 2011;
REFERENCE INTERVALS. Units Canine Feline Bovine Equine Porcine Ovine
REFERENCE INTERVALS Biochemistry Units Canine Feline Bovine Equine Porcine Ovine Sodium mmol/l 144-151 149-156 135-151 135-148 140-150 143-151 Potassium mmol/l 3.9-5.3 3.3-5.2 3.9-5.9 3.0-5.0 4.7-7.1 4.6-7.0
Anticoagulation Therapy in LTC
Anticoagulation Therapy in LTC By: Cynthia Leung, RPh, BScPhm, PharmD. Clinical Consultant Pharmacist MediSystem Pharmacy Jun 11, 2013 Agenda Stroke and Bleeding Risk Assessment Review of Oral Anticoagulation
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
Study. Human Tolerance of Low Molecular Weight. Polyethylene Markers. Prof. Dr. Dr. Ruprecht Keller. Krankenhaus Merheim Zentrallabor
Study Human Tolerance of Low Molecular Weight Polyethylene Markers Prof. Dr. Dr. Ruprecht Keller Krankenhaus Merheim Zentrallabor Ostmerheimerstr. 00 509 Köln Human Tolerance of Low Molecular Weight Polyethylene
NEW RCPCH REFERENCE RANGES-
s vary between populations and age groups and it is important to always check the reference Haematology: Haemoglobin Male 130 175 g/l 0 6 days 145-220 g/l Female 115 165 g/l 7 days 140-186 g/l 8 days 3
ADPedKD: detailed description of data which will be collected in this registry
ADPedKD: detailed description of data which will be collected in this registry I. Basic data 1. Patient ID: will be given automatically 2. Personal information - Date of informed consent: DD/MM/YYYY -
Research Data Available
Research Data Available Main Questionnaire General Topic Socio-economic status Occupational exposure Physical activity Mobile phone usage Sleeping patterns smoking Childhood conditions/illnesses/family
SydPath Reference Intervals for Clinical Trials (Contract Pathology Unit) Unauthorised Copy
HAEMATOLOGY APTT 1 150 M 25 35 sec APTT 1 150 F 25 35 sec Basophils Cord 2 weeks M 0.0 0.4 10^9/L Basophils Cord 2 weeks F 0.0 0.4 10^9/L Basophils 2 wks 3 mths M 0.0 0.2 10^9/L Basophils 2 wks 3 mths
Hamilton Regional Laboratory Medicine Program
Created: April 2002 of Review: February 2004 of Review: June 2006 of Review: July 2007, St. Joseph s Healthcare went live with Meditech as of June18, 2007. of Review: August 2009 of Review: December 2011;
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Spire Portsmouth Hospital Bartons Road Havant PO9 5NP United Kingdom Contact: Natalie Peck E-Mail: natalie.peck@spirehealthcare.com Website:
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
Intestinal Failure Referral Form
Intestinal Failure Referral Form This form must be completed in full and emailed to UCLH.IFReferrals@nhs.net or call 07958 263178. Please complete all sections of the form. Please note that incomplete
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
LabDriver Audit Trail Example
LabDriver Audit Trail Example Sample details:= (SampleDId=82051) Lab no: 0902168 Centre: CR Centre (CentreId=1079) (BatchSId=1317) Status: Checked Blood date: 13/05/2009 time: 11:31:00 lab received: 13/05/2009
BC Biomedical Laboratories Adult Reference Ranges
BC Biomedical Laboratories Adult s Name Age 25 OH VITAMIN D Blood B 0-100 nmol/l Interpretation: < 25 Deficient 25-74 Insufficient 75-199 Sufficient > 200 Toxic 5HIAA (CALC) Urine B 0-100
FBC interpretation. Dr. Gergely Varga
FBC interpretation Dr. Gergely Varga #1 71 Y/O female, c/o weakness Test Undertaken : FBC (FBC) Sample Type: Whole Blood [ - 26.09.11 14:59] Hb 7.3 g/dl* 12.0-15.5 RBC 3.5 10^12/l * 3.80-5.60 Hct 0.24
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Spire Portsmouth Hospital Bartons Road Havant PO9 5NP United Kingdom Contact: Natalie Peck E-Mail: natalie.peck@spirehealthcare.com Website:
Adverse Experience Reporting
Managing and reporting adverse events Key learning objectives By the end of this session, you will be able to: Define and classify an adverse event; Differentiate between serious and severe adverse events;
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: