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ID

42046

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

Versions (3)
  1. 10/27/16 10/27/16 -
  2. 10/27/16 10/27/16 -
  3. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
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March 15, 2021

DOI

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License

Creative Commons BY 4.0
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    End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    German English

    End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    1 forms  
    Medications
    Description

    Medications

    Alias
    UMLS CUI-1
    C0013227
    Number of medication
    Description

    Number of medication

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0013227
    Name of medication
    Description

    Name of medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Dose of Medication
    Description

    medication dose

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1]
    C3174092
    mg
    Start of therapy
    Description

    Start of therapy

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Stop of therapy
    Description

    therapy Stop date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    Ongoing
    Description

    Ongoing medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Indication
    Description

    indication for medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Adverse Events
    Description

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Number of Adverse Event
    Description

    Number of Adverse Event

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0237753
    Description of Adverse Event
    Description

    Description of Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Start of treatment
    Description

    Start of treatment

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    End of treatment
    Description

    End of treatment

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    Intensity
    Description

    adverse event intensity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Related to the Study Medication
    Description

    Adverse event related to study treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1510821
    Action taken with study medication
    Description

    Action taken with study medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1704758
    Outcome
    Description

    Adverse event outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    Is the AE serious?
    Description

    is the adverse event serious

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Transfusion history during the entry study
    Description

    Transfusion history during the entry study

    Alias
    UMLS CUI-1
    C1519604
    Date of blood transfusion
    Description

    Date of blood transfusion

    Data type

    date

    Measurement units
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C1264703
    YYYY-MM-DD
    Number of units
    Description

    Number of units

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0086252
    UMLS CUI [1,2]
    C0449961
    Any special events circumstances transfusion?
    Description

    Any special events circumstances transfusion?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1879316
    if yes, please specify
    Description

    if yes, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1879316
    Signature date
    Description

    Sub-Itemgroup: Investigator's signature

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937
    Investigator's signature
    Description

    Sub-Itemgroup: Investigator's signature

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2346576
    Conclusion of the Study and Termination
    Description

    Conclusion of the Study and Termination

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Early Ending of the Study or Termination
    Description

    Early Ending of the Study or Termination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2718058
    If yes, study termination by?
    Description

    If yes, study termination by?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348570
    If yes, date of the Termination:
    Description

    If yes, date of the Termination:

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670
    If yes, reason for the study termination
    Description

    If yes, reason for the study termination

    Data type

    text

    specify
    Description

    specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C2348570
    Comments on the patient
    Description

    Comments on the patient

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0030705
    Investigator's name
    Description

    Investigators name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Stamp
    Description

    Stamp

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032755
    Signature date
    Description

    Sub-Itemgroup: Investigator's signature

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937
    Investigator's signature
    Description

    Sub-Itemgroup: Investigator's signature

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2346576
    Back to the top of the page

    Similar models

    End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Medications
    C0013227 (UMLS CUI-1)
    Number of medication
    Item
    Number of medication
    integer
    C0237753 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Name of medication
    Item
    Name of medication
    text
    C0013227 (UMLS CUI [1])
    medication dose
    Item
    Dose of Medication
    float
    C3174092 (UMLS CUI [1])
    Start of therapy
    Item
    Start of therapy
    date
    C3173309 (UMLS CUI [1])
    therapy Stop date
    Item
    Stop of therapy
    date
    C1531784 (UMLS CUI [1])
    Ongoing medication
    Item
    Ongoing
    boolean
    C2826666 (UMLS CUI [1])
    indication for medication
    Item
    Indication
    text
    C2826696 (UMLS CUI [1])
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Number of Adverse Event
    Item
    Number of Adverse Event
    integer
    C0877248 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Description of Adverse Event
    Item
    Description of Adverse Event
    text
    C0877248 (UMLS CUI [1])
    Start of treatment
    Item
    Start of treatment
    date
    C3173309 (UMLS CUI [1])
    End of treatment
    Item
    End of treatment
    date
    C1531784 (UMLS CUI [1])
    adverse event intensity
    Item
    Intensity
    text
    C1710066 (UMLS CUI [1])
    Adverse event related to study treatment
    Item
    Related to the Study Medication
    boolean
    C1510821 (UMLS CUI [1])
    Action taken with study medication
    Item
    Action taken with study medication
    boolean
    C1704758 (UMLS CUI [1])
    Adverse event outcome
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1])
    is the adverse event serious
    Item
    Is the AE serious?
    boolean
    C1519255 (UMLS CUI [1])
    Item Group
    Transfusion history during the entry study
    C1519604 (UMLS CUI-1)
    Date of blood transfusion
    Item
    Date of blood transfusion
    date
    C1264703 (UMLS CUI [1])
    Number of units
    Item
    Number of units
    integer
    C0086252 (UMLS CUI [1,1])
    C0449961 (UMLS CUI [1,2])
    Item
    Any special events circumstances transfusion?
    integer
    C0877248 (UMLS CUI [1,1])
    C1879316 (UMLS CUI [1,2])
    Are all inclusion criteria fulfilled?
    Code List
    Any special events circumstances transfusion?
    CL Item
    no (0)
    CL Item
    yes (1)
    if yes, please specify
    Item
    if yes, please specify
    text
    C0877248 (UMLS CUI [1,1])
    C1879316 (UMLS CUI [1,2])
    Signature date
    Item
    Signature date
    date
    C0807937 (UMLS CUI [1])
    Item
    Investigator's signature
    integer
    C2346576 (UMLS CUI [1])
    Are all inclusion criteria fulfilled?
    Code List
    Investigator's signature
    CL Item
    no (0)
    CL Item
    yes (1)
    Item Group
    Conclusion of the Study and Termination
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Item
    Early Ending of the Study or Termination
    integer
    C2718058 (UMLS CUI [1])
    Early Ending of the Study or Termination
    Code List
    Early Ending of the Study or Termination
    CL Item
    no (0)
    CL Item
    yes (1)
    Item
    If yes, study termination by?
    integer
    C2348570 (UMLS CUI [1])
    If yes, study termination by?
    Code List
    If yes, study termination by?
    CL Item
    the physician (1)
    CL Item
    the patient (2)
    If yes, date of the Termination:
    Item
    If yes, date of the Termination:
    date
    C2983670 (UMLS CUI [1])
    If yes, reason for the study termination
    Item
    text
    specify
    Item
    specify
    text
    C0566251 (UMLS CUI [1,1])
    C2348570 (UMLS CUI [1,2])
    Comments on the patient
    Item
    Comments on the patient
    text
    C0947611 (UMLS CUI [1,1])
    C0030705 (UMLS CUI [1,2])
    Investigators name
    Item
    Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Stamp
    Item
    Stamp
    text
    C0032755 (UMLS CUI [1])
    Signature date
    Item
    Signature date
    date
    C0807937 (UMLS CUI [1])
    Item
    Investigator's signature
    integer
    C2346576 (UMLS CUI [1])
    Are all inclusion criteria fulfilled?
    Code List
    Investigator's signature
    CL Item
    no (0)
    CL Item
    yes (1)
    Back to the top of the page 

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