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ID

31068

Description

Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00384150

Link

https://clinicaltrials.gov/show/NCT00384150

Keywords

Versions (1)
  1. 7/17/18 7/17/18 -
Copyright Holder

See clinicaltrials.gov

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July 17, 2018

DOI

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License

Creative Commons BY 4.0
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    Eligibility Non-Hodgkin Lymphoma NCT00384150

    English

    Eligibility Non-Hodgkin Lymphoma NCT00384150

    1 forms  
    Criteria
    Description

    Criteria

    demonstrated a response (cr, cru, or pr) on study 114-nh-301 (galiximab in combination with rituximab compared with rituximab in combination with placebo) and then relapsed or progressed with a ttp >=6 months. relapsed disease is defined as documented disease progression using the international workshop response criteria (iwrc).
    Description

    Disease Response | In complete remission | Complete remission Uncertain | Partial response | galiximab/rituximab | Rituximab Placebo Combined | Recurrent disease | Disease Progression | Time to Progression

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1704632
    UMLS CUI [2]
    C0677874
    UMLS CUI [3,1]
    C0677874
    UMLS CUI [3,2]
    C0087130
    UMLS CUI [4]
    C1521726
    UMLS CUI [5]
    C1327912
    UMLS CUI [6,1]
    C0393022
    UMLS CUI [6,2]
    C1696465
    UMLS CUI [6,3]
    C0205195
    UMLS CUI [7]
    C0277556
    UMLS CUI [8]
    C0242656
    UMLS CUI [9]
    C2985467
    bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension.
    Description

    Measurable Disease 2-Dimensional | Lesion Size Linear Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1705052
    UMLS CUI [2,1]
    C0221198
    UMLS CUI [2,2]
    C0456389
    UMLS CUI [2,3]
    C0205132
    UMLS CUI [2,4]
    C1265611
    acceptable hematologic, hepatic, and renal function.
    Description

    Hematologic function | Liver function | Renal function

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C0232804
    key exclusion criteria:
    Description

    Exclusion Criteria Main

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0680251
    UMLS CUI [1,2]
    C1542147
    any lymphoma therapy between final visit on study 114-nh-301 and study day 1 of this retreatment study.
    Description

    Therapeutic procedure Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0024299
    chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to study day 1.
    Description

    Adrenal Cortex Hormones chronic Inflammatory disorder | Adrenal Cortex Hormones chronic Autoimmune Diseases | Adrenal Cortex Hormones Intermittent Inflammatory disorder | Adrenal Cortex Hormones Intermittent Autoimmune Diseases

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0001617
    UMLS CUI [1,2]
    C0205191
    UMLS CUI [1,3]
    C1290884
    UMLS CUI [2,1]
    C0001617
    UMLS CUI [2,2]
    C0205191
    UMLS CUI [2,3]
    C0004364
    UMLS CUI [3,1]
    C0001617
    UMLS CUI [3,2]
    C0205267
    UMLS CUI [3,3]
    C1290884
    UMLS CUI [4,1]
    C0001617
    UMLS CUI [4,2]
    C0205267
    UMLS CUI [4,3]
    C0004364
    transfusion-dependent subjects.
    Description

    Study Subject Transfusion dependent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0681850
    UMLS CUI [1,2]
    C1698624
    presence of central nervous system (cns) lymphoma.
    Description

    Central nervous system lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0742472
    histologic transformation.
    Description

    Transformation Histologic

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0040682
    UMLS CUI [1,2]
    C0205462
    presence of pleural or peritoneal effusion with positive cytology for lymphoma.
    Description

    Pleural effusion | Peritoneal effusion | Positive Cytology Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032227
    UMLS CUI [2]
    C0003964
    UMLS CUI [3,1]
    C3846509
    UMLS CUI [3,2]
    C0024299
    another primary malignancy requiring active treatment.
    Description

    Primary tumor Treatment required for

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677930
    UMLS CUI [1,2]
    C0332121
    serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
    Description

    Disease Serious Non-Malignant | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Study Protocol

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [1,3]
    C1518371
    UMLS CUI [2]
    C0018802
    UMLS CUI [3]
    C0020295
    UMLS CUI [4,1]
    C0004623
    UMLS CUI [4,2]
    C0205318
    UMLS CUI [5,1]
    C0042769
    UMLS CUI [5,2]
    C0205318
    UMLS CUI [6,1]
    C0026946
    UMLS CUI [6,2]
    C0205318
    UMLS CUI [7,1]
    C0348080
    UMLS CUI [7,2]
    C2945640
    UMLS CUI [7,3]
    C2348563
    new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to study day 1.
    Description

    Heart Disease New York Heart Association Classification | Myocardial Infarction

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C1275491
    UMLS CUI [2]
    C0027051
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    Similar models

    Eligibility Non-Hodgkin Lymphoma NCT00384150

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Disease Response | In complete remission | Complete remission Uncertain | Partial response | galiximab/rituximab | Rituximab Placebo Combined | Recurrent disease | Disease Progression | Time to Progression
    Item
    demonstrated a response (cr, cru, or pr) on study 114-nh-301 (galiximab in combination with rituximab compared with rituximab in combination with placebo) and then relapsed or progressed with a ttp >=6 months. relapsed disease is defined as documented disease progression using the international workshop response criteria (iwrc).
    boolean
    C1704632 (UMLS CUI [1])
    C0677874 (UMLS CUI [2])
    C0677874 (UMLS CUI [3,1])
    C0087130 (UMLS CUI [3,2])
    C1521726 (UMLS CUI [4])
    C1327912 (UMLS CUI [5])
    C0393022 (UMLS CUI [6,1])
    C1696465 (UMLS CUI [6,2])
    C0205195 (UMLS CUI [6,3])
    C0277556 (UMLS CUI [7])
    C0242656 (UMLS CUI [8])
    C2985467 (UMLS CUI [9])
    Measurable Disease 2-Dimensional | Lesion Size Linear Quantity
    Item
    bidimensionally measurable disease with at least 1 lesion >=2.0 cm in a single dimension.
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    C0221198 (UMLS CUI [2,1])
    C0456389 (UMLS CUI [2,2])
    C0205132 (UMLS CUI [2,3])
    C1265611 (UMLS CUI [2,4])
    Hematologic function | Liver function | Renal function
    Item
    acceptable hematologic, hepatic, and renal function.
    boolean
    C0221130 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C0232804 (UMLS CUI [3])
    Exclusion Criteria Main
    Item
    key exclusion criteria:
    boolean
    C0680251 (UMLS CUI [1,1])
    C1542147 (UMLS CUI [1,2])
    Therapeutic procedure Lymphoma
    Item
    any lymphoma therapy between final visit on study 114-nh-301 and study day 1 of this retreatment study.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    Adrenal Cortex Hormones chronic Inflammatory disorder | Adrenal Cortex Hormones chronic Autoimmune Diseases | Adrenal Cortex Hormones Intermittent Inflammatory disorder | Adrenal Cortex Hormones Intermittent Autoimmune Diseases
    Item
    chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to study day 1.
    boolean
    C0001617 (UMLS CUI [1,1])
    C0205191 (UMLS CUI [1,2])
    C1290884 (UMLS CUI [1,3])
    C0001617 (UMLS CUI [2,1])
    C0205191 (UMLS CUI [2,2])
    C0004364 (UMLS CUI [2,3])
    C0001617 (UMLS CUI [3,1])
    C0205267 (UMLS CUI [3,2])
    C1290884 (UMLS CUI [3,3])
    C0001617 (UMLS CUI [4,1])
    C0205267 (UMLS CUI [4,2])
    C0004364 (UMLS CUI [4,3])
    Study Subject Transfusion dependent
    Item
    transfusion-dependent subjects.
    boolean
    C0681850 (UMLS CUI [1,1])
    C1698624 (UMLS CUI [1,2])
    Central nervous system lymphoma
    Item
    presence of central nervous system (cns) lymphoma.
    boolean
    C0742472 (UMLS CUI [1])
    Transformation Histologic
    Item
    histologic transformation.
    boolean
    C0040682 (UMLS CUI [1,1])
    C0205462 (UMLS CUI [1,2])
    Pleural effusion | Peritoneal effusion | Positive Cytology Lymphoma
    Item
    presence of pleural or peritoneal effusion with positive cytology for lymphoma.
    boolean
    C0032227 (UMLS CUI [1])
    C0003964 (UMLS CUI [2])
    C3846509 (UMLS CUI [3,1])
    C0024299 (UMLS CUI [3,2])
    Primary tumor Treatment required for
    Item
    another primary malignancy requiring active treatment.
    boolean
    C0677930 (UMLS CUI [1,1])
    C0332121 (UMLS CUI [1,2])
    Disease Serious Non-Malignant | Congestive heart failure | Hydronephrosis | Bacterial Infections Uncontrolled | Virus Diseases Uncontrolled | Mycoses Uncontrolled | Condition compromises Study Protocol
    Item
    serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
    boolean
    C0012634 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C1518371 (UMLS CUI [1,3])
    C0018802 (UMLS CUI [2])
    C0020295 (UMLS CUI [3])
    C0004623 (UMLS CUI [4,1])
    C0205318 (UMLS CUI [4,2])
    C0042769 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    C0026946 (UMLS CUI [6,1])
    C0205318 (UMLS CUI [6,2])
    C0348080 (UMLS CUI [7,1])
    C2945640 (UMLS CUI [7,2])
    C2348563 (UMLS CUI [7,3])
    Heart Disease New York Heart Association Classification | Myocardial Infarction
    Item
    new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to study day 1.
    boolean
    C0018799 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
    C0027051 (UMLS CUI [2])
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