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ID

18341

Beschrijving

Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Link

https://clinicaltrials.gov/ct2/show/NCT01303952

Trefwoorden

  1. 2016-11-01 2016-11-01 -
Geüploaded op

1 november 2016

DOI

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Licentie

Creative Commons BY 4.0

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    Follow Up - Visit 20 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Follow Up - Visit 20 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Date of Visit
    Beschrijving

    Date of Visit

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit
    Beschrijving

    Date of Visit

    Datatype

    text

    Maateenheden
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C1320303
    YYYY-MM-DD
    LDH
    Beschrijving

    LDH

    Alias
    UMLS CUI-1
    C0202113
    LDH
    Beschrijving

    Sub-Itemgroup: Demographics

    Datatype

    float

    Maateenheden
    • U/l
    Alias
    UMLS CUI [1]
    C0202113
    U/l
    Vital signs
    Beschrijving

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    1. Systolic blood pressure
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    1. Diastolic blood pressure
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    2. Systolic blood pressure
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    2. Diastolic blood pressure
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    3. Systolic blood pressure
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    3. Diastolic blood pressure
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    integer

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Sitting heart rate
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    integer

    Maateenheden
    • beats per minute
    Alias
    UMLS CUI [1]
    C2029904
    beats per minute
    Body temperature
    Beschrijving

    Sub-Itemgroup: Vital Signs

    Datatype

    float

    Maateenheden
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Circulatory Symptoms
    Beschrijving

    Circulatory Symptoms

    Alias
    UMLS CUI-1
    C0476270
    Thrombophlebitis/Deep Vein Thrombosis
    Beschrijving

    Thrombophlebitis/Deep Vein Thrombosis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0040046
    UMLS CUI [2]
    C0149871
    Pulmonary Embolus
    Beschrijving

    Pulmonary Embolus

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0034065
    Cerebrovascular Accident
    Beschrijving

    Cerebrovascular Accident

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0038454
    Amputation
    Beschrijving

    Amputation

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0002688
    Myocardial Infarction
    Beschrijving

    Myocardial Infarction

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0027051
    Transient Ischemic Attack
    Beschrijving

    Transient Ischemic Attack

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0007787
    Unstable Angina
    Beschrijving

    Unstable Angina

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0002965
    Renal Vein Thrombosis
    Beschrijving

    Renal Vein Thrombosis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0238457
    Mesenteric Vein Thrombosis
    Beschrijving

    Mesenteric Vein Thrombosis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0267412
    Portal Vein Thrombosis (Budd-Chiari)
    Beschrijving

    Portal Vein Thrombosis (Budd-Chiari)

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0155773
    Gangrene
    Beschrijving

    Gangrene

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0017086
    Acute Peripheral Vascular Occlusion
    Beschrijving

    Acute Peripheral Vascular Occlusion

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0240728
    Sudden Death
    Beschrijving

    Sudden Death

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0011071
    Comments
    Beschrijving

    Comments

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611
    Signature principal investigator
    Beschrijving

    Signature principal investigator

    Alias
    UMLS CUI-1
    C1519316
    UMLS CUI-2
    C1521895
    Signature date
    Beschrijving

    Signature date

    Datatype

    text

    Maateenheden
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C0807937
    YYYY-MM-DD
    Signature investigator
    Beschrijving

    Signature investigator

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2346576

    Similar models

    Follow Up - Visit 20 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Date of Visit
    C1320303 (UMLS CUI-1)
    Date of Visit
    Item
    Date of Visit
    text
    C1320303 (UMLS CUI [1])
    Item Group
    LDH
    C0202113 (UMLS CUI-1)
    LDH
    Item
    LDH
    float
    C0202113 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    1. Systolic blood pressure
    Item
    1. Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    1. Diastolic blood pressure
    Item
    1. Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    2. Systolic blood pressure
    Item
    2. Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    2. Diastolic blood pressure
    Item
    2. Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    3. Systolic blood pressure
    Item
    3. Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    3. Diastolic blood pressure
    Item
    3. Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Sitting heart rate
    Item
    Sitting heart rate
    integer
    C2029904 (UMLS CUI [1])
    Body temperature
    Item
    Body temperature
    float
    C0005903 (UMLS CUI [1])
    Item Group
    Circulatory Symptoms
    C0476270 (UMLS CUI-1)
    Item
    Thrombophlebitis/Deep Vein Thrombosis
    integer
    C0040046 (UMLS CUI [1])
    C0149871 (UMLS CUI [2])
    Code List
    Thrombophlebitis/Deep Vein Thrombosis
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Pulmonary Embolus
    integer
    C0034065 (UMLS CUI [1])
    Code List
    Pulmonary Embolus
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Cerebrovascular Accident
    integer
    C0038454 (UMLS CUI [1])
    Code List
    Cerebrovascular Accident
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Amputation
    integer
    C0002688 (UMLS CUI [1])
    Code List
    Amputation
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Myocardial Infarction
    integer
    C0027051 (UMLS CUI [1])
    Code List
    Myocardial Infarction
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Transient Ischemic Attack
    integer
    C0007787 (UMLS CUI [1])
    Code List
    Transient Ischemic Attack
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Unstable Angina
    integer
    C0002965 (UMLS CUI [1])
    Code List
    Unstable Angina
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Renal Vein Thrombosis
    integer
    C0238457 (UMLS CUI [1])
    Code List
    Renal Vein Thrombosis
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Mesenteric Vein Thrombosis
    integer
    C0267412 (UMLS CUI [1])
    Code List
    Mesenteric Vein Thrombosis
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Portal Vein Thrombosis (Budd-Chiari)
    integer
    C0155773 (UMLS CUI [1])
    Code List
    Portal Vein Thrombosis (Budd-Chiari)
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Gangrene
    integer
    C0017086 (UMLS CUI [1])
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Acute Peripheral Vascular Occlusion
    integer
    C0240728 (UMLS CUI [1])
    Code List
    Acute Peripheral Vascular Occlusion
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Sudden Death
    integer
    C0011071 (UMLS CUI [1])
    CL Item
    no (0)
    CL Item
    yes (1)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Signature principal investigator
    C1519316 (UMLS CUI-1)
    C1521895 (UMLS CUI-2)
    Signature date
    Item
    Signature date
    text
    C0807937 (UMLS CUI [1])
    Item
    Signature investigator
    integer
    C2346576 (UMLS CUI [1])
    Code List
    Signature investigator
    CL Item
    no (0)
    CL Item
    yes (1)

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