0 Bedömningar

ID

18222

Beskrivning

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

Länk

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

Nyckelord

  1. 2016-10-25 2016-10-25 -
Uppladdad den

25 oktober 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Maintenance Period - Visit 14 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Maintenance Period - Visit 14 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Date of Visit
    Beskrivning

    Date of Visit

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit
    Beskrivning

    Date of Visit

    Datatyp

    text

    Måttenheter
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C1320303
    YYYY-MM-DD
    Was the study terminated prematurely?
    Beskrivning

    early termination

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2718058
    LDH
    Beskrivning

    LDH

    Alias
    UMLS CUI-1
    C0202113
    LDH
    Beskrivning

    Sub-Itemgroup: Demographics

    Datatyp

    float

    Måttenheter
    • U/l
    Alias
    UMLS CUI [1]
    C0202113
    U/l
    Vital signs
    Beskrivning

    Vital signs

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

    Sub-Itemgroup: Vital Signs

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    1. Diastolic blood pressure
    Beskrivning

    Sub-Itemgroup: Vital Signs

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    2. Systolic blood pressure
    Beskrivning

    Sub-Itemgroup: Vital Signs

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    2. Diastolic blood pressure
    Beskrivning

    Sub-Itemgroup: Vital Signs

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    3. Systolic blood pressure
    Beskrivning

    Sub-Itemgroup: Vital Signs

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    3. Diastolic blood pressure
    Beskrivning

    Sub-Itemgroup: Vital Signs

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Sitting heart rate
    Beskrivning

    Sub-Itemgroup: Vital Signs

    Datatyp

    integer

    Måttenheter
    • beats per minute
    Alias
    UMLS CUI [1]
    C2029904
    beats per minute
    Body temperature
    Beskrivning

    Sub-Itemgroup: Vital Signs

    Datatyp

    float

    Måttenheter
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Circulatory Symptoms
    Beskrivning

    Circulatory Symptoms

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

    Thrombophlebitis/Deep Vein Thrombosis

    Datatyp

    integer

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

    Pulmonary Embolus

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0034065
    Cerebrovascular Accident
    Beskrivning

    Cerebrovascular Accident

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0038454
    Amputation
    Beskrivning

    Amputation

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0002688
    Myocardial Infarction
    Beskrivning

    Myocardial Infarction

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0027051
    Transient Ischemic Attack
    Beskrivning

    Transient Ischemic Attack

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0007787
    Unstable Angina
    Beskrivning

    Unstable Angina

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0002965
    Renal Vein Thrombosis
    Beskrivning

    Renal Vein Thrombosis

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0238457
    Mesenteric Vein Thrombosis
    Beskrivning

    Mesenteric Vein Thrombosis

    Datatyp

    integer

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

    Portal Vein Thrombosis (Budd-Chiari)

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0155773
    Gangrene
    Beskrivning

    Gangrene

    Datatyp

    integer

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

    Acute Peripheral Vascular Occlusion

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0240728
    Sudden Death
    Beskrivning

    Sudden Death

    Datatyp

    integer

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

    Patient suffers from other accompanying illnesses?

    Datatyp

    integer

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

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

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Comments
    Beskrivning

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Study medication
    Beskrivning

    Study medication

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

    Patient received the study medication

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2826299
    Comments
    Beskrivning

    study medication comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826299
    Signature principal investigator
    Beskrivning

    Signature principal investigator

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

    Signature date

    Datatyp

    text

    Måttenheter
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C0807937
    YYYY-MM-DD
    Signature investigator
    Beskrivning

    Signature investigator

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2346576

    Similar models

    Maintenance Period - Visit 14 UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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)

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial