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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

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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  
    Medikation
    Description

    Medikation

    Alias
    UMLS CUI-1
    C0013227
    Nummer der Medikation
    Description

    Number of medication

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0013227
    Name der Medikation
    Description

    Name of medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Dosis
    Description

    medication dose

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1]
    C3174092
    mg
    Therapiestart
    Description

    Start of therapy

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Therapieende
    Description

    therapy Stop date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    Fortgeführte Medikation
    Description

    Ongoing medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Indikation für Medikation
    Description

    indication for medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Adverse Events
    Description

    Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Nummer des Adverse Event
    Description

    Number of Adverse Event

    Data type

    integer

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

    Description of Adverse Event

    Data type

    text

    Alias
    UMLS CUI [1]
    C0877248
    Therapiestart
    Description

    Start of treatment

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Therapieende
    Description

    End of treatment

    Data type

    date

    Alias
    UMLS CUI [1]
    C1531784
    Schweregrad des Adverse Events
    Description

    adverse event intensity

    Data type

    text

    Alias
    UMLS CUI [1]
    C1710066
    Zusammenhang zur Studienmedikation
    Description

    Adverse event related to study treatment

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1510821
    Änderungen an Studienmedikation vorgenommen
    Description

    Action taken with study medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1704758
    Adverse Event Outcome
    Description

    Adverse event outcome

    Data type

    text

    Alias
    UMLS CUI [1]
    C1705586
    Liegt ein schwerwiegendes Adverse Event vor?
    Description

    is the adverse event serious

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255
    Einjahres Transfusionsgeschichte
    Description

    Einjahres Transfusionsgeschichte

    Alias
    UMLS CUI-1
    C1519604
    Datum der Bluttransfusion
    Description

    Date of blood transfusion

    Data type

    date

    Measurement units
    • YYYY-MM-DD
    Alias
    UMLS CUI [1]
    C1264703
    YYYY-MM-DD
    Anzahl Einheiten
    Description

    Number of units

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0086252
    UMLS CUI [1,2]
    C0449961
    Irgendwelche die Transfusion begleitende Ereignisse?
    Description

    Any special events circumstances transfusion?

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1879316
    wenn ja, bitte spezifizieren
    Description

    if yes, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C1879316
    Datum Unterschrift
    Description

    Signature date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937
    Unterschrift Prüfarzt
    Description

    Investigators signature

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2346576
    Studienergebnis und -abschluss
    Description

    Studienergebnis und -abschluss

    Alias
    UMLS CUI-1
    C1707478
    UMLS CUI-2
    C0008972
    Vorzeitiger Studienabbruch
    Description

    Early Ending of the Study or Termination

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2718058
    Wenn ja, beendet von wem?
    Description

    If yes, study termination by?

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348570
    Wenn ja, Abbruchdatum:
    Description

    If yes, date of the Termination:

    Data type

    date

    Alias
    UMLS CUI [1]
    C2983670
    Wenn ja, Grund für Studienabbruch
    Description

    If yes, reason for the study termination

    Data type

    text

    näher beschreiben
    Description

    specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0566251
    UMLS CUI [1,2]
    C2348570
    Kommentare zum Patienten
    Description

    Comments on the patient

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0947611
    UMLS CUI [1,2]
    C0030705
    Name des Prüfarztes
    Description

    Investigators name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Briefmarke
    Description

    Stamp

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032755
    Datum Unterschrift
    Description

    Signature date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0807937
    Unterschrift Prüfarzt
    Description

    Investigators 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
    Medikation
    C0013227 (UMLS CUI-1)
    Number of medication
    Item
    Nummer der Medikation
    integer
    C0237753 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Name of medication
    Item
    Name der Medikation
    text
    C0013227 (UMLS CUI [1])
    medication dose
    Item
    Dosis
    float
    C3174092 (UMLS CUI [1])
    Start of therapy
    Item
    Therapiestart
    date
    C3173309 (UMLS CUI [1])
    therapy Stop date
    Item
    Therapieende
    date
    C1531784 (UMLS CUI [1])
    Ongoing medication
    Item
    Fortgeführte Medikation
    boolean
    C2826666 (UMLS CUI [1])
    indication for medication
    Item
    Indikation für Medikation
    text
    C2826696 (UMLS CUI [1])
    Item Group
    Adverse Events
    C0877248 (UMLS CUI-1)
    Number of Adverse Event
    Item
    Nummer des Adverse Event
    integer
    C0877248 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Description of Adverse Event
    Item
    Beschreibung des Adverse Event
    text
    C0877248 (UMLS CUI [1])
    Start of treatment
    Item
    Therapiestart
    date
    C3173309 (UMLS CUI [1])
    End of treatment
    Item
    Therapieende
    date
    C1531784 (UMLS CUI [1])
    adverse event intensity
    Item
    Schweregrad des Adverse Events
    text
    C1710066 (UMLS CUI [1])
    Adverse event related to study treatment
    Item
    Zusammenhang zur Studienmedikation
    boolean
    C1510821 (UMLS CUI [1])
    Action taken with study medication
    Item
    Änderungen an Studienmedikation vorgenommen
    boolean
    C1704758 (UMLS CUI [1])
    Adverse event outcome
    Item
    Adverse Event Outcome
    text
    C1705586 (UMLS CUI [1])
    is the adverse event serious
    Item
    Liegt ein schwerwiegendes Adverse Event vor?
    boolean
    C1519255 (UMLS CUI [1])
    Item Group
    Einjahres Transfusionsgeschichte
    C1519604 (UMLS CUI-1)
    Date of blood transfusion
    Item
    Datum der Bluttransfusion
    date
    C1264703 (UMLS CUI [1])
    Number of units
    Item
    Anzahl Einheiten
    integer
    C0086252 (UMLS CUI [1,1])
    C0449961 (UMLS CUI [1,2])
    Item
    Irgendwelche die Transfusion begleitende Ereignisse?
    integer
    C0877248 (UMLS CUI [1,1])
    C1879316 (UMLS CUI [1,2])
    Are all inclusion criteria fulfilled?
    Code List
    Irgendwelche die Transfusion begleitende Ereignisse?
    CL Item
    Nein (0)
    CL Item
    Ja (1)
    if yes, please specify
    Item
    wenn ja, bitte spezifizieren
    text
    C0877248 (UMLS CUI [1,1])
    C1879316 (UMLS CUI [1,2])
    Signature date
    Item
    Datum Unterschrift
    date
    C0807937 (UMLS CUI [1])
    Item
    Unterschrift Prüfarzt
    integer
    C2346576 (UMLS CUI [1])
    Are all inclusion criteria fulfilled?
    Code List
    Unterschrift Prüfarzt
    CL Item
    Nein (0)
    CL Item
    Ja (1)
    Item Group
    Studienergebnis und -abschluss
    C1707478 (UMLS CUI-1)
    C0008972 (UMLS CUI-2)
    Item
    Vorzeitiger Studienabbruch
    integer
    C2718058 (UMLS CUI [1])
    Early Ending of the Study or Termination
    Code List
    Vorzeitiger Studienabbruch
    CL Item
    Nein (0)
    CL Item
    Ja (1)
    Item
    Wenn ja, beendet von wem?
    integer
    C2348570 (UMLS CUI [1])
    If yes, study termination by?
    Code List
    Wenn ja, beendet von wem?
    CL Item
    dem Arzt (1)
    CL Item
    dem Patient (2)
    If yes, date of the Termination:
    Item
    Wenn ja, Abbruchdatum:
    date
    C2983670 (UMLS CUI [1])
    If yes, reason for the study termination
    Item
    Wenn ja, Grund für Studienabbruch
    text
    specify
    Item
    näher beschreiben
    text
    C0566251 (UMLS CUI [1,1])
    C2348570 (UMLS CUI [1,2])
    Comments on the patient
    Item
    Kommentare zum Patienten
    text
    C0947611 (UMLS CUI [1,1])
    C0030705 (UMLS CUI [1,2])
    Investigators name
    Item
    Name des Prüfarztes
    text
    C2826892 (UMLS CUI [1])
    Stamp
    Item
    Briefmarke
    text
    C0032755 (UMLS CUI [1])
    Signature date
    Item
    Datum Unterschrift
    date
    C0807937 (UMLS CUI [1])
    Item
    Unterschrift Prüfarzt
    integer
    C2346576 (UMLS CUI [1])
    Are all inclusion criteria fulfilled?
    Code List
    Unterschrift Prüfarzt
    CL Item
    Nein (0)
    CL Item
    Ja (1)
    Back to the top of the page 

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