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ID

21066

Description

An Efficacy and Tolerability Study of Bortezomib in Combination With Rituximab Standard Therapy in Participants With Relapsed or Refractory Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01902862

Link

https://clinicaltrials.gov/show/NCT01902862

Keywords

Versions (1)
  1. 4/7/17 4/7/17 -
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April 7, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma, Follicular NCT01902862

    English

    Eligibility Lymphoma, Follicular NCT01902862

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
    Description

    Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024301
    UMLS CUI [1,2]
    C0679557
    UMLS CUI [1,3]
    C0277556
    UMLS CUI [1,4]
    C1514815
    UMLS CUI [2]
    C1272836
    UMLS CUI [3]
    C0882818
    participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
    Description

    rituximab planned, prior chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0393022
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [2]
    C1514457
    women must be either postmenopausal or sterilized; negative pregnancy test at screening
    Description

    postmenopausal state, sterilized, pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232970
    UMLS CUI [2]
    C0015787
    UMLS CUI [3]
    C0032961
    participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
    Description

    total bilirubin, creatinine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201913
    UMLS CUI [2]
    C0201976
    participants with karnofsky status greater than or equal to 60 percent
    Description

    karnofsky

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
    Description

    Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C1176309
    UMLS CUI [2,1]
    C1514463
    UMLS CUI [2,2]
    C1541445
    participants with previous known allergic reaction to bortezomib, boron or mannitol
    Description

    previous known allergic reaction to bortezomib, boron or mannitol

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1176309
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0024730
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0006030
    participants with life-expectancy of less than 3 months
    Description

    life-expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
    Description

    history of cancer, basalioma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2735088
    UMLS CUI [2]
    C0007117
    participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
    Description

    peripheral neuropathy, common terminology criteria for adverse events (ctcae)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031117
    UMLS CUI [1,2]
    C3888020
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    Similar models

    Eligibility Lymphoma, Follicular NCT01902862

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Lymphoma, Follicular; histological diagnosis; Recurrent disease; Refractory Disease | Lymphoma stage | Cell positive for CD20 antigen
    Item
    participants with histologically confirmed relapsed or refractory follicular stage iii or iv, grade 1 and 2, cluster of differentiation 20 plus (cd20+) lymphoma (who-world health organization) that requires therapy
    boolean
    C0024301 (UMLS CUI [1,1])
    C0679557 (UMLS CUI [1,2])
    C0277556 (UMLS CUI [1,3])
    C1514815 (UMLS CUI [1,4])
    C1272836 (UMLS CUI [2])
    C0882818 (UMLS CUI [3])
    rituximab planned, prior chemotherapy
    Item
    participants in whom treatment with rituximab is planned after greater than or equal to 2 cytostatic (inhibition of cell growth) previous therapies
    boolean
    C0393022 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C1514457 (UMLS CUI [2])
    postmenopausal state, sterilized, pregnancy
    Item
    women must be either postmenopausal or sterilized; negative pregnancy test at screening
    boolean
    C0232970 (UMLS CUI [1])
    C0015787 (UMLS CUI [2])
    C0032961 (UMLS CUI [3])
    total bilirubin, creatinine
    Item
    participants with total bilirubin below 1.5-fold upper limit of normal (uln) and creatinine below 2-fold uln
    boolean
    C0201913 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    karnofsky
    Item
    participants with karnofsky status greater than or equal to 60 percent
    boolean
    C0206065 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Prior Therapy; bortezomib | Prior Therapy; bortezomib/rituximab
    Item
    participants with previous treatment with bortezomib within 6 months before enrollment or previous treatment with a combination of rituximab and bortezomib
    boolean
    C1514463 (UMLS CUI [1,1])
    C1176309 (UMLS CUI [1,2])
    C1514463 (UMLS CUI [2,1])
    C1541445 (UMLS CUI [2,2])
    previous known allergic reaction to bortezomib, boron or mannitol
    Item
    participants with previous known allergic reaction to bortezomib, boron or mannitol
    boolean
    C0020517 (UMLS CUI [1,1])
    C1176309 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0024730 (UMLS CUI [2,2])
    C0020517 (UMLS CUI [3,1])
    C0006030 (UMLS CUI [3,2])
    life-expectancy
    Item
    participants with life-expectancy of less than 3 months
    boolean
    C0023671 (UMLS CUI [1])
    history of cancer, basalioma
    Item
    participants with malignant neoplasm (cancerous - new growth that is not normal; tumor) (except basalioma) within previous 5 years
    boolean
    C2735088 (UMLS CUI [1])
    C0007117 (UMLS CUI [2])
    peripheral neuropathy, common terminology criteria for adverse events (ctcae)
    Item
    participants with peripheral (not central) neuropathy (a disturbance in the function of the brain or spinal cord that may affect the nerves and muscles of the body) common terminology criteria for adverse events (ctcae) grade greater than or equal to 2
    boolean
    C0031117 (UMLS CUI [1,1])
    C3888020 (UMLS CUI [1,2])
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