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ID

18225

Description

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

Keywords

  1. 10/25/16 10/25/16 -
Uploaded on

October 25, 2016

DOI

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License

Creative Commons BY 4.0

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    Maintenance Period - Visit 15 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Maintenance Period - Visit 15 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Date of Visit
    Description

    Date of Visit

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit
    Description

    Date of Visit

    Data type

    text

    Measurement units
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C1320303
    YYYY-MM-DD
    Was the study terminated prematurely?
    Description

    early termination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2718058
    LDH
    Description

    LDH

    Alias
    UMLS CUI-1
    C0202113
    LDH
    Description

    Sub-Itemgroup: Demographics

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C0202113
    U/l
    Vital signs
    Description

    Vital signs

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

    Sub-Itemgroup: Vital Signs

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    1. Diastolic blood pressure
    Description

    Sub-Itemgroup: Vital Signs

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    2. Systolic blood pressure
    Description

    Sub-Itemgroup: Vital Signs

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    2. Diastolic blood pressure
    Description

    Sub-Itemgroup: Vital Signs

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    3. Systolic blood pressure
    Description

    Sub-Itemgroup: Vital Signs

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    3. Diastolic blood pressure
    Description

    Sub-Itemgroup: Vital Signs

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Sitting heart rate
    Description

    Sub-Itemgroup: Vital Signs

    Data type

    integer

    Measurement units
    • beats per minute
    Alias
    UMLS CUI [1]
    C2029904
    beats per minute
    Body temperature
    Description

    Sub-Itemgroup: Vital Signs

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Circulatory Symptoms
    Description

    Circulatory Symptoms

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

    Thrombophlebitis/Deep Vein Thrombosis

    Data type

    integer

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

    Pulmonary Embolus

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0034065
    Cerebrovascular Accident
    Description

    Cerebrovascular Accident

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0038454
    Amputation
    Description

    Amputation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0002688
    Myocardial Infarction
    Description

    Myocardial Infarction

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0027051
    Transient Ischemic Attack
    Description

    Transient Ischemic Attack

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0007787
    Unstable Angina
    Description

    Unstable Angina

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0002965
    Renal Vein Thrombosis
    Description

    Renal Vein Thrombosis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0238457
    Mesenteric Vein Thrombosis
    Description

    Mesenteric Vein Thrombosis

    Data type

    integer

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

    Portal Vein Thrombosis (Budd-Chiari)

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0155773
    Gangrene
    Description

    Gangrene

    Data type

    integer

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

    Acute Peripheral Vascular Occlusion

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0240728
    Sudden Death
    Description

    Sudden Death

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0011071
    Patient suffers from other accompanying illnesses?
    Description

    Patient suffers from other accompanying illnesses?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0009488
    Only for Woman (under 50): Is the pregnancy test negativ?
    Description

    Only for Woman (under 50): Is the pregnancy test negativ?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Study medication
    Description

    Study medication

    Alias
    UMLS CUI-1
    C0013227
    Patient received the study medication (900mg)
    Description

    Patient received the study medication

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2826299
    Comments
    Description

    study medication comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826299
    Signature principal investigator
    Description

    Signature principal investigator

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

    Signature date

    Data type

    text

    Measurement units
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C0807937
    YYYY-MM-DD
    Signature investigator
    Description

    Signature investigator

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2346576

    Similar models

    Maintenance Period - Visit 15 Maintenance Period UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit
    C1320303 (UMLS CUI-1)
    Date of Visit
    Item
    Date of Visit
    text
    C1320303 (UMLS CUI [1])
    Item
    Was the study terminated prematurely?
    integer
    C2718058 (UMLS CUI [1])
    Code List
    Was the study terminated prematurely?
    CL Item
    no (0)
    CL Item
    yes (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)
    Item
    Patient suffers from other accompanying illnesses?
    integer
    C0009488 (UMLS CUI [1])
    Code List
    Patient suffers from other accompanying illnesses?
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    Only for Woman (under 50): Is the pregnancy test negativ?
    integer
    C0032976 (UMLS CUI [1])
    Code List
    Only for Woman (under 50): Is the pregnancy test negativ?
    CL Item
    no (0)
    CL Item
    yes (1)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Study medication
    C0013227 (UMLS CUI-1)
    Item
    Patient received the study medication (900mg)
    integer
    C2826299 (UMLS CUI [1])
    Code List
    Patient received the study medication (900mg)
    CL Item
    no (0)
    CL Item
    yes (1)
    study medication comments
    Item
    Comments
    text
    C2826299 (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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