ID

41349

Descripción

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Pre-Treatment Physical Exam Form has to be filled in at the screening visit. It is used to record the physical examination prior to initiation of treatment. To be completed within 72 hours before treatment initiation.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

Palabras clave

Versiones (1)
  1. 3/9/20 3/9/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

3 de septiembre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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    Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

    Inglés

    Pre-Treatment Physical Exam

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site #
    Descripción

    Study centre number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient #
    Descripción

    patient ID

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descripción

    visit date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Investigator Name
    Descripción

    Investigator Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date:
    Descripción

    (dd-mmm-yyyy)

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Time:
    Descripción

    (0000-2359)

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Blood Pressure (Systolic):
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood Pressure (Diastolic):
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Respiration:
    Descripción

    Respiratory Rate

    Tipo de datos

    integer

    Unidades de medida
    • per min.
    Alias
    UMLS CUI [1]
    C0231832
    per min.
    Height:
    Descripción

    Body Height

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005890
    Height - Unit:
    Descripción

    Body Height Unit

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005890
    UMLS CUI [1,2]
    C1519795
    Heart Rate
    Descripción

    Heart Rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Temperature:
    Descripción

    Body Temperature

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005903
    Body Temperature - Unit:
    Descripción

    Body Temperature Unit

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1519795
    Weight:
    Descripción

    Body Weight

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005910
    Weight - Unit:
    Descripción

    Body Weight Unit

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005910
    UMLS CUI [1,2]
    C1519795
    Pre-treatment Physical Exam
    Descripción

    Pre-treatment Physical Exam

    Alias
    UMLS CUI-1
    C0031809
    UMLS CUI-2
    C2709094
    General Appearance
    Descripción

    Physical Examination: General Appearance - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1148438
    UMLS CUI [1,2]
    C0449438
    General Appearance - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1148438
    UMLS CUI [1,2]
    C1521902
    Skin
    Descripción

    Physical Examination: Skin - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0437750
    UMLS CUI [1,2]
    C0449438
    Skin - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0437750
    UMLS CUI [1,2]
    C1521902
    Head/Neck
    Descripción

    Physical Examination: Head/Neck - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0460004
    UMLS CUI [1,3]
    C0449438
    Head/Neck - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0460004
    UMLS CUI [1,3]
    C1521902
    Lymph Nodes
    Descripción

    Physical Examination: Lymph Nodes - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024204
    UMLS CUI [1,3]
    C0449438
    Lymph Nodes - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024204
    UMLS CUI [1,3]
    C1521902
    Breasts
    Descripción

    Physical Examination: Breasts - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199850
    UMLS CUI [1,3]
    C0449438
    Breasts - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199850
    UMLS CUI [1,3]
    C1521902
    Heart
    Descripción

    Physical Examination: Heart - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0018787
    UMLS CUI [1,3]
    C0449438
    Heart - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0018787
    UMLS CUI [1,3]
    C1521902
    Lungs
    Descripción

    Physical Examination: Lungs - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024109
    UMLS CUI [1,3]
    C0449438
    Lungs - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0024109
    UMLS CUI [1,3]
    C1521902
    Abdomen
    Descripción

    Physical Examination: Abdomen - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [1,3]
    C0449438
    Abdomen - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [1,3]
    C1521902
    Genitalia
    Descripción

    Physical Examination: Genitalia - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0017420
    UMLS CUI [1,3]
    C0449438
    Genitalia - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0017420
    UMLS CUI [1,3]
    C1521902
    Extremities
    Descripción

    Physical Examination: Extremities - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0015385
    UMLS CUI [1,3]
    C0449438
    Extremities - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0015385
    UMLS CUI [1,3]
    C1521902
    Neurologic
    Descripción

    Physical Examination: Neurologic - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0027853
    UMLS CUI [1,3]
    C0449438
    Neurologic - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0027853
    UMLS CUI [1,3]
    C1521902
    Rectal
    Descripción

    Physical Examination: Rectal - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199900
    UMLS CUI [1,3]
    C0449438
    Rectal - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0199900
    UMLS CUI [1,3]
    C1521902
    Other
    Descripción

    Physical Examination: Other - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0449438
    Other - specify:
    Descripción

    Specify body system

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Other - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Other
    Descripción

    Physical Examination: Other - status

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0449438
    Other - specify:
    Descripción

    Specify body system

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Other - Abnormal, specify:
    Descripción

    (abnormality should associate with Medical History, see Medical History Form)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0031809
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
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    Similar models

    Pre-Treatment Physical Exam

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study centre number
    Item
    Site #
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    patient ID
    Item
    Patient #
    integer
    C2348585 (UMLS CUI [1])
    visit date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Investigator Name
    Item
    Investigator Name
    text
    C2826892 (UMLS CUI [1])
    Date
    Item
    Date:
    date
    C1320303 (UMLS CUI [1])
    Time
    Item
    Time:
    time
    C0040223 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic Blood Pressure
    Item
    Blood Pressure (Systolic):
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Blood Pressure (Diastolic):
    integer
    C0428883 (UMLS CUI [1])
    Respiratory Rate
    Item
    Respiration:
    integer
    C0231832 (UMLS CUI [1])
    Body Height
    Item
    Height:
    float
    C0005890 (UMLS CUI [1])
    Item
    Height - Unit:
    text
    C0005890 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Body Height Unit
    Code List
    Height - Unit:
    CL Item
    inches (inches)
    CL Item
    cm (cm)
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Body Temperature
    Item
    Temperature:
    float
    C0005903 (UMLS CUI [1])
    Item
    Body Temperature - Unit:
    text
    C0005903 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Body Temperature Unit
    Code List
    Body Temperature - Unit:
    CL Item
    °F (°F)
    CL Item
    °C (°C)
    Body Weight
    Item
    Weight:
    float
    C0005910 (UMLS CUI [1])
    Item
    Weight - Unit:
    text
    C0005910 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Body Weight Unit
    Code List
    Weight - Unit:
    CL Item
    lbs (lbs)
    CL Item
    kg (kg)
    Item Group
    Pre-treatment Physical Exam
    C0031809 (UMLS CUI-1)
    C2709094 (UMLS CUI-2)
    Item
    General Appearance
    text
    C1148438 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Physical Examination: General Appearance
    Code List
    General Appearance
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: General Appearance - specify
    Item
    General Appearance - Abnormal, specify:
    text
    C1148438 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item
    Skin
    text
    C0437750 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Physical Examination: General Appearance
    Code List
    Skin
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Skin - specify
    Item
    Skin - Abnormal, specify:
    text
    C0437750 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Item
    Head/Neck
    text
    C0031809 (UMLS CUI [1,1])
    C0460004 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Head/Neck
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Head/Neck - specify
    Item
    Head/Neck - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0460004 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Lymph Nodes
    text
    C0031809 (UMLS CUI [1,1])
    C0024204 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Lymph Nodes
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Lymph Nodes - specify
    Item
    Lymph Nodes - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0024204 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Breasts
    text
    C0031809 (UMLS CUI [1,1])
    C0199850 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Breasts
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Breasts - specify
    Item
    Breasts - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0199850 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Heart
    text
    C0031809 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Heart
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Heart - specify
    Item
    Heart - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0018787 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Lungs
    text
    C0031809 (UMLS CUI [1,1])
    C0024109 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Lungs
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Lungs - specify
    Item
    Lungs - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0024109 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Abdomen
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Abdomen
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Abdomen - specify
    Item
    Abdomen - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Genitalia
    text
    C0031809 (UMLS CUI [1,1])
    C0017420 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Genitalia
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Genitalia - specify
    Item
    Genitalia - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0017420 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Extremities
    text
    C0031809 (UMLS CUI [1,1])
    C0015385 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Extremities
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Extremities - specify
    Item
    Extremities - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0015385 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Neurologic
    text
    C0031809 (UMLS CUI [1,1])
    C0027853 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Neurologic
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Neurologic - specify
    Item
    Neurologic - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0027853 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Rectal
    text
    C0031809 (UMLS CUI [1,1])
    C0199900 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Rectal
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Rectal - specify
    Item
    Rectal - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0199900 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Other
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Other
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Other - specify
    Item
    Other - specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Physical Examination: Other - specify
    Item
    Other - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Other
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0449438 (UMLS CUI [1,3])
    Physical Examination: General Appearance
    Code List
    Other
    CL Item
    Normal (Normal)
    CL Item
    Abnormal, specify: (Abnormal, specify:)
    Physical Examination: Other - specify
    Item
    Other - specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Physical Examination: Other - specify
    Item
    Other - Abnormal, specify:
    text
    C0031809 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
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