0 Evaluaciones
ID

31820

Descripción

Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

Palabras clave

Versiones (1)
  1. 1/10/18 1/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

1 de octubre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619

    Inglés

    Visit 00

    1 formularios  
    1. StudyEvent: ODM
      1. Visit 00
    Demography
    Descripción

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of consent
    Descripción

    Informed Consent Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985782
    Date of birth
    Descripción

    Patient Date of birth

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Descripción

    Gender

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Descripción

    Racial group

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0034510
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Height
    Descripción

    Body Height

    Tipo de datos

    integer

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Body Weight
    Descripción

    Body Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Pregnancy Test
    Descripción

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Not done
    Descripción

    Pregnancy Test; Not done

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1272696
    Date and Time of Sampling
    Descripción

    Pregnancy Test; Sampling; Date in Time; Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Result
    Descripción

    Pregnancy Test finding

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0427777
    Specific Medical History/Risk Factors for VTE
    Descripción

    Specific Medical History/Risk Factors for VTE

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-3
    C0035648
    UMLS CUI-4
    C1861172
    VTE
    Descripción

    Medical History; VTE

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C1861172
    PE
    Descripción

    Medical History; Pulmonary Embolism

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0034065
    Stroke
    Descripción

    Medical History; Cerebrovascular accident

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0038454
    Myocardial Infarction
    Descripción

    Medical History; Myocardial Infarction

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0027051
    Prior major surgery or trauma within the last 12 months
    Descripción

    Medical History, major surgery, within the last year; Medical History, Major injury, within the last year

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0679637
    UMLS CUI [1,3]
    C3842283
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0332677
    UMLS CUI [2,3]
    C3842283
    Neoplastic disease
    Descripción

    Medical History; Neoplastic disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C1882062
    Inflammatory Bowel Disease
    Descripción

    Medical History; Inflammatory Bowel Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0021390
    Chronic Obstructive Pulmonary Disease
    Descripción

    Medical History; Chronic Obstructive Airway Disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0024117
    Immobilization
    Descripción

    Medical History; Immobilization

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0020944
    Oral contraceptive use
    Descripción

    Medical History; contraceptives, oral; use of

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0009905
    UMLS CUI [1,3]
    C1524063
    Varicose veins
    Descripción

    Medical History; History of Varicose veins

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0455534
    Prothrombotic states
    Descripción

    Medical History; State; Before; Thrombosis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C1442792
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C0040053
    Congestive Heart Failure
    Descripción

    Medical History; Congestive Heart Failure

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0018802
    Past medical or surgical history
    Descripción

    Past medical or surgical history

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0489540
    Past medical or surgical history
    Descripción

    Medical History; History of surgical procedures

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0489540
    Persistence of symptoms
    Descripción

    Medical history; history of surgical procedures; Symptoms, persistent

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0489540
    UMLS CUI [1,3]
    C1457887
    UMLS CUI [1,4]
    C0205322
    Hematology
    Descripción

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Laboratory Name
    Descripción

    Hematology finding; Performing Laboratory

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1882331
    Date and time of sampling
    Descripción

    Hematology finding; Collection of blood specimen for laboratory procedure; Date in time; Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Platelet
    Descripción

    Hematology finding; Finding of Platelet Count

    Tipo de datos

    float

    Unidades de medida
    • 10^9/L
    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C1287267
    10^9/L
    Hemoglobin
    Descripción

    Hematology finding; Hemoglobin

    Tipo de datos

    float

    Unidades de medida
    • g/dL
    Alias
    UMLS CUI [1,1]
    C0474523
    UMLS CUI [1,2]
    C0019046
    g/dL
    Biochemistry
    Descripción

    Biochemistry

    Alias
    UMLS CUI-1
    C0005477
    Laboratory Name
    Descripción

    Biochemistry; Performing Laboratory

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C1882331
    Date and time of sampling
    Descripción

    Biochemistry; Collection of blood specimen for laboratory procedure; Date in time; Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Creatinine
    Descripción

    Biochemistry; Creatinine measurement

    Tipo de datos

    float

    Unidades de medida
    • mg/dL
    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C0201976
    mg/dL
    AST
    Descripción

    Biochemistry; Aspartate aminotransferase measurement

    Tipo de datos

    float

    Unidades de medida
    • UL
    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C0201899
    UL
    ALT
    Descripción

    Biochemistry; Alanine aminotransferase measurement

    Tipo de datos

    float

    Unidades de medida
    • UL
    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C0201836
    UL
    Total Bilirubin
    Descripción

    Biochemistry; Bilirubin, total measurement

    Tipo de datos

    float

    Unidades de medida
    • mg/dL
    Alias
    UMLS CUI [1,1]
    C0005477
    UMLS CUI [1,2]
    C0201913
    mg/dL
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    Similar models

    Visit 00

    1 formularios
    1. StudyEvent: ODM
      1. Visit 00
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Informed Consent Date
    Item
    Date of consent
    date
    C2985782 (UMLS CUI [1])
    Patient Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Sex
    CL Item
    Male (Male)
    CL Item
    Female (Female)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    Racial group
    Code List
    Race
    CL Item
    Caucasian (Caucasian)
    CL Item
    Black (Black)
    CL Item
    Asian, Oriental (Asian, Oriental)
    CL Item
    Other (specify) (Other (specify))
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Body Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Body Weight
    float
    C0005910 (UMLS CUI [1])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Pregnancy Test; Not done
    Item
    Not done
    boolean
    C0032976 (UMLS CUI [1,1])
    C1272696 (UMLS CUI [1,2])
    Pregnancy Test; Sampling; Date in Time; Time
    Item
    Date and Time of Sampling
    datetime
    C0032976 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Item
    Result
    text
    C0427777 (UMLS CUI [1])
    Pregnancy Test finding
    Code List
    Result
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    Item Group
    Specific Medical History/Risk Factors for VTE
    C0262926 (UMLS CUI-1)
    C0035648 (UMLS CUI-3)
    C1861172 (UMLS CUI-4)
    Medical History; VTE
    Item
    VTE
    boolean
    C0262926 (UMLS CUI [1,1])
    C1861172 (UMLS CUI [1,2])
    Medical History; Pulmonary Embolism
    Item
    PE
    boolean
    C0262926 (UMLS CUI [1,1])
    C0034065 (UMLS CUI [1,2])
    Medical History; Cerebrovascular accident
    Item
    Stroke
    boolean
    C0262926 (UMLS CUI [1,1])
    C0038454 (UMLS CUI [1,2])
    Medical History; Myocardial Infarction
    Item
    Myocardial Infarction
    boolean
    C0262926 (UMLS CUI [1,1])
    C0027051 (UMLS CUI [1,2])
    Medical History, major surgery, within the last year; Medical History, Major injury, within the last year
    Item
    Prior major surgery or trauma within the last 12 months
    boolean
    C0262926 (UMLS CUI [1,1])
    C0679637 (UMLS CUI [1,2])
    C3842283 (UMLS CUI [1,3])
    C0262926 (UMLS CUI [2,1])
    C0332677 (UMLS CUI [2,2])
    C3842283 (UMLS CUI [2,3])
    Medical History; Neoplastic disease
    Item
    Neoplastic disease
    boolean
    C0262926 (UMLS CUI [1,1])
    C1882062 (UMLS CUI [1,2])
    Medical History; Inflammatory Bowel Disease
    Item
    Inflammatory Bowel Disease
    boolean
    C0262926 (UMLS CUI [1,1])
    C0021390 (UMLS CUI [1,2])
    Medical History; Chronic Obstructive Airway Disease
    Item
    Chronic Obstructive Pulmonary Disease
    boolean
    C0262926 (UMLS CUI [1,1])
    C0024117 (UMLS CUI [1,2])
    Medical History; Immobilization
    Item
    Immobilization
    boolean
    C0262926 (UMLS CUI [1,1])
    C0020944 (UMLS CUI [1,2])
    Medical History; contraceptives, oral; use of
    Item
    Oral contraceptive use
    boolean
    C0262926 (UMLS CUI [1,1])
    C0009905 (UMLS CUI [1,2])
    C1524063 (UMLS CUI [1,3])
    Medical History; History of Varicose veins
    Item
    Varicose veins
    boolean
    C0262926 (UMLS CUI [1,1])
    C0455534 (UMLS CUI [1,2])
    Medical History; State; Before; Thrombosis
    Item
    Prothrombotic states
    boolean
    C0262926 (UMLS CUI [1,1])
    C1442792 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C0040053 (UMLS CUI [1,4])
    Item
    Congestive Heart Failure
    text
    C0262926 (UMLS CUI [1,1])
    C0018802 (UMLS CUI [1,2])
    Medical History; Congestive Heart Failure
    Code List
    Congestive Heart Failure
    CL Item
    No (No)
    CL Item
    Yes, grade I (Yes, grade I)
    CL Item
    Yes, grade II (Yes, grade II)
    CL Item
    Yes, grade III (Yes, grade III)
    CL Item
    Yes, grade IV (Yes, grade IV)
    Item Group
    Past medical or surgical history
    C0262926 (UMLS CUI-1)
    C0489540 (UMLS CUI-2)
    Medical History; History of surgical procedures
    Item
    Past medical or surgical history
    text
    C0262926 (UMLS CUI [1,1])
    C0489540 (UMLS CUI [1,2])
    Item
    Persistence of symptoms
    text
    C0262926 (UMLS CUI [1,1])
    C0489540 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    C0205322 (UMLS CUI [1,4])
    Medical history; history of surgical procedures; Symptoms, persistent
    Code List
    Persistence of symptoms
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Not applicable (Not applicable)
    Item Group
    Hematology
    C0474523 (UMLS CUI-1)
    Hematology finding; Performing Laboratory
    Item
    Laboratory Name
    text
    C0474523 (UMLS CUI [1,1])
    C1882331 (UMLS CUI [1,2])
    Hematology finding; Collection of blood specimen for laboratory procedure; Date in time; Time
    Item
    Date and time of sampling
    datetime
    C0474523 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Hematology finding; Finding of Platelet Count
    Item
    Platelet
    float
    C0474523 (UMLS CUI [1,1])
    C1287267 (UMLS CUI [1,2])
    Hematology finding; Hemoglobin
    Item
    Hemoglobin
    float
    C0474523 (UMLS CUI [1,1])
    C0019046 (UMLS CUI [1,2])
    Item Group
    Biochemistry
    C0005477 (UMLS CUI-1)
    Biochemistry; Performing Laboratory
    Item
    Laboratory Name
    text
    C0005477 (UMLS CUI [1,1])
    C1882331 (UMLS CUI [1,2])
    Biochemistry; Collection of blood specimen for laboratory procedure; Date in time; Time
    Item
    Date and time of sampling
    datetime
    C0005477 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Biochemistry; Creatinine measurement
    Item
    Creatinine
    float
    C0005477 (UMLS CUI [1,1])
    C0201976 (UMLS CUI [1,2])
    Biochemistry; Aspartate aminotransferase measurement
    Item
    AST
    float
    C0005477 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    Biochemistry; Alanine aminotransferase measurement
    Item
    ALT
    float
    C0005477 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    Biochemistry; Bilirubin, total measurement
    Item
    Total Bilirubin
    float
    C0005477 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
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