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ID

13942

Description

A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Keywords

Versions (1)
  1. 3/17/16 3/17/16 -
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March 17, 2016

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Creative Commons BY-NC 3.0
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    First Follow-up LenaMain-Study

    English

    First Follow-Up

    1 forms  
    1. StudyEvent: ODM
      1. First Follow-Up
    Follow-Up
    Description

    Follow-Up

    Date of visit
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Date
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Patient Vital Status
    Description

    Patient Status

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846084 (undefined)
    Myeloma: lines of treatment
    Description

    Myeloma: lines of treatment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0026764 (Multiple Myeloma)
    SNOMED
    55921005
    UMLS CUI [1,2]
    C0040808 (Treatment Protocols)
    Secondary disease occurred?
    Description

    Secondary disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0277555 (Secondary disease, NOS)
    Secondary disease: please specify
    Description

    Secondary disease

    Data type

    text

    Alias
    UMLS CUI [1]
    C0277555 (Secondary disease, NOS)
    Has a progressive disease been diagnosed?
    Description

    Did the patient suffer progress during the study,prior to this visit?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1335499 (Progressive Disease)
    Response
    Description

    Response

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0521982 (Response to treatment)
    SNOMED
    182985004
    Laboratory:pregnancy test
    Description

    Laboratory:pregnancy test

    Is the subject of childbearing potential?
    Description

    Childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3831118 (Childbearing Potential)
    Pregnancy test result
    Description

    Pregnancy test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0032976 (Pregnancy Tests)
    SNOMED
    74036000
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    Description

    Menstruation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0025344 (Menstruation)
    SNOMED
    248957007
    Survival Status
    Description

    Survival Status

    Survival Status
    Description

    Survival Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1148433 (Vital Status)
    Date of death
    Description

    Date of death

    Data type

    date

    Alias
    UMLS CUI [1]
    C1148348 (Date of death)
    SNOMED
    399753006
    LOINC
    MTHU014693
    Death certificate available?
    Description

    Death certificate

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0011066 (Death Certificates)
    SNOMED
    307930005
    Autopsy performed?
    Description

    Autopsy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004398 (Autopsy)
    SNOMED
    29240004
    LOINC
    LA20097-4
    Cause of death
    Description

    Cause of death

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0007465 (Cause of Death)
    SNOMED
    16100001
    LOINC
    LA10595-9
    Other cause of death:please specify
    Description

    Cause of death

    Data type

    text

    Alias
    UMLS CUI [1]
    C0007465 (Cause of Death)
    SNOMED
    16100001
    LOINC
    LA10595-9
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    Similar models

    First Follow-Up

    1 forms
    1. StudyEvent: ODM
      1. First Follow-Up
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Follow-Up
    Date
    Item
    Date of visit
    date
    C0011008 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item
    Patient Vital Status
    text
    C3846084 (UMLS CUI [1])
    Patient Status
    Code List
    Patient Vital Status
    CL Item
    Alive (0)
    CL Item
    Dead (1)
    Myeloma: lines of treatment
    Item
    Myeloma: lines of treatment
    text
    C0026764 (UMLS CUI [1,1])
    C0040808 (UMLS CUI [1,2])
    Secondary disease
    Item
    Secondary disease occurred?
    boolean
    C0277555 (UMLS CUI [1])
    Secondary disease
    Item
    Secondary disease: please specify
    text
    C0277555 (UMLS CUI [1])
    Progressive disease
    Item
    Has a progressive disease been diagnosed?
    boolean
    C1335499 (UMLS CUI [1])
    Item
    Response
    integer
    C0521982 (UMLS CUI [1])
    Response
    Code List
    Response
    CL Item
    sCR (0)
    CL Item
    CR (1)
    CL Item
    vgPR (2)
    CL Item
    PR (3)
    CL Item
    SD (5)
    CL Item
    PD (6)
    Item Group
    Laboratory:pregnancy test
    Childbearing potential
    Item
    Is the subject of childbearing potential?
    boolean
    C3831118 (UMLS CUI [1])
    Item
    Pregnancy test result
    integer
    C0032976 (UMLS CUI [1])
    Pregnancy test
    Code List
    Pregnancy test result
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    integer
    C0025344 (UMLS CUI [1])
    Menstruation
    Code List
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    CL Item
    No menstruation (0)
    CL Item
    Yes (1)
    CL Item
    No (2)
    Item Group
    Survival Status
    Item
    Survival Status
    integer
    C1148433 (UMLS CUI [1])
    Survival Status
    Code List
    Survival Status
    CL Item
    alive (0)
    CL Item
    dead (1)
    Date of death
    Item
    Date of death
    date
    C1148348 (UMLS CUI [1])
    Death certificate
    Item
    Death certificate available?
    boolean
    C0011066 (UMLS CUI [1])
    Autopsy
    Item
    Autopsy performed?
    boolean
    C0004398 (UMLS CUI [1])
    Item
    Cause of death
    integer
    C0007465 (UMLS CUI [1])
    Cause of death
    Code List
    Cause of death
    CL Item
    malignant disease (1)
    CL Item
    side effect (2)
    CL Item
    infection (3)
    CL Item
    second neoplasm (4)
    CL Item
    cardiovascular disease (5)
    CL Item
    other chronic comorbidity (6)
    CL Item
    other comorbidity (7)
    CL Item
    unknown (8)
    CL Item
    progressive disease (9)
    Cause of death
    Item
    Other cause of death:please specify
    text
    C0007465 (UMLS CUI [1])
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