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ID

12232

Description

An open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) versus fludarabine and cyclophosphamide alone (FC) in previously treated patients with CD20 positive B-cell chronic lymphocytic leukemia (CLL). FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients NCT00090051 Roche BO17072

Mots-clés

  1. 30/09/2015 30/09/2015 -
  2. 27/10/2015 27/10/2015 -
Téléchargé le

27 octobre 2015

DOI

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Licence

Creative Commons BY-NC 3.0

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    CLL Lab BO17072 NCT00090051

    Laboratories of Chronic lymphocytic leukemia NCT0090051

    Laboratory analysis
    Description

    Laboratory analysis

    Sample collection date
    Description

    Sample collection date

    Type de données

    date

    Unités de mesure
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0011008
    dd/mm/yy
    Lab ID number
    Description

    Lab ID number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1114691
    Hematology
    Description

    Hematology

    Alias
    UMLS CUI-1
    C0474523
    Hemoglobin
    Description

    Hemoglobin

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0019046
    Hematocrit
    Description

    Hematocrit

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0518014
    Red Blood Cells
    Description

    Red Blood Cells

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0362910
    Leukocytes (total)
    Description

    Leukocytes (total)

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0023508
    Neutrophils
    Description

    Neutrophils

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0948762
    Basophils
    Description

    Basophils

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0200641
    Eosinophils
    Description

    Eosinophils

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0362902
    Lymphocytes
    Description

    Lymphocytes

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0024264
    Monocytes
    Description

    Monocytes

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0026473
    Other cells
    Description

    Other cells

    Type de données

    integer

    Platelets
    Description

    Platelets

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0005821
    Prothrombin time
    Description

    Prothrombin time

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0491338
    Please comment on any abnormal other cells and specify white cell morphology
    Description

    Comment

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0947611
    Coombs tests indirect/direct
    Description

    Coombs tests indirect/direct

    Sample collection date
    Description

    Sample collection date

    Type de données

    date

    Unités de mesure
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C1549498
    dd/mm/yy
    Indirect Coombs tests
    Description

    Indirect Coombs tests

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0430262
    Direct Coombs tests
    Description

    Direct Coombs tests

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0151569
    Blood chemistry
    Description

    Blood chemistry

    Alias
    UMLS CUI-1
    C0005774
    Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
    Description

    Aspartate transaminase (Serum glutamic oxaloacetic transaminase)

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0004002
    Alanine transaminase (Serum glutamate-pyruvate transaminase)
    Description

    Alanine transaminase (Serum glutamate-pyruvate transaminase)

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0001899
    Alk. phosphatase
    Description

    Alk. phosphatase

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0002059
    Bilirubin total
    Description

    Bilirubin total

    Type de données

    text

    Alias
    UMLS CUI-1
    C0201913
    Urea (BUN)
    Description

    Urea (BUN)

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0523961
    Serum creatinine
    Description

    Serum creatinine

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0201976
    Estimated creatinine clearance
    Description

    Estimated creatinine clearance

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0373595
    Lactate dehydrogenase
    Description

    Lactate dehydrogenase

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0202113
    Total protein
    Description

    Total protein

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0555903
    Albumin
    Description

    Albumin

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0201838
    Blood glucose (random)
    Description

    Blood glucose (random)

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0202042
    beta-2-microglobulin
    Description

    beta-2-microglobulin

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0201910
    Electrocytes
    Description

    Electrocytes

    Sodium
    Description

    Sodium

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0337443
    Calcium
    Description

    Calcium

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0201925
    Potassium
    Description

    Potassium

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0202194
    Phosphate
    Description

    Phosphate

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0523826
    Lymphocyte immunophenotyping (local lab)
    Description

    Lymphocyte immunophenotyping (local lab)

    Sample collection date
    Description

    Sample collection date

    Type de données

    date

    Unités de mesure
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0011008
    dd/mm/yy
    Lymphocytes
    Description

    Lymphocytes

    Type de données

    float

    Unités de mesure
    • %
    Alias
    UMLS CUI [1]
    C0200635
    %
    Monocytes
    Description

    Monocytes

    Type de données

    float

    Unités de mesure
    • %
    Alias
    UMLS CUI [1]
    C0026473
    %
    Neutrophils
    Description

    Neutrophils

    Type de données

    float

    Unités de mesure
    • %
    Alias
    UMLS CUI [1]
    C0948762
    %
    Lymphocyte immunophenotyping (local lab)
    Description

    Lymphocyte immunophenotyping (local lab)

    Lymphocyte immunophenotyping Lab value
    Description

    Lymphocyte immunophenotyping Lab value

    Type de données

    integer

    Unités de mesure
    • %
    Alias
    UMLS CUI [1]
    C0079718
    Lymphocyte immunophenotyping Lab parameter
    Description

    Lymphocyte immunophenotyping Lab parameter

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0079718
    Comments
    Description

    Comments

    Type de données

    text

    Alias
    UMLS CUI-1
    C0947611
    Blood sampling for molecular analyses
    Description

    Blood sampling for molecular analyses

    Sample number
    Description

    Sample number 101

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0370003
    Blood sampling for VH mutation status and chromosome abnormalities
    Description

    Blood sampling for VH mutation status and chromosome abnormalities

    Sample number 401
    Description

    Sample number 401

    Type de données

    integer

    Bone marrow examination
    Description

    Bone marrow examination

    Alias
    UMLS CUI-1
    C0005957
    Date of examination
    Description

    Date of examination

    Type de données

    date

    Unités de mesure
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C2826643
    dd/mm/yy
    Result of Bone marrow examination
    Description

    Result of Bone marrow examination

    Result of Bone marrow examination normal result
    Description

    Result of Bone marrow examination normal result

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0427695
    Result of Bone marrow examination abnormal result
    Description

    Result of Bone marrow examination abnormal result

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0427696
    Is bone marrow involved with CLL?
    Description

    Is bone marrow involved with CLL?

    Percentage of bone marrow involvement
    Description

    Percentage of bone marrow involvement

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1517677
    no involvement
    Description

    no involvement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1517677
    Lymphoid nodules in bone marrow?
    Description

    Lymphoid nodules in bone marrow?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3807548

    Similar models

    Laboratories of Chronic lymphocytic leukemia NCT0090051

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Laboratory analysis
    Date
    Item
    Sample collection date
    date
    C0011008 (UMLS CUI [1])
    Lab ID number
    Item
    Lab ID number
    integer
    C1114691 (UMLS CUI [1])
    Item Group
    Hematology
    C0474523 (UMLS CUI-1)
    Hemoglobin
    Item
    Hemoglobin
    integer
    C0019046 (UMLS CUI [1])
    Hematocrit
    Item
    Hematocrit
    integer
    C0518014 (UMLS CUI [1])
    RBC
    Item
    Red Blood Cells
    integer
    C0362910 (UMLS CUI [1])
    Leukocytes
    Item
    Leukocytes (total)
    integer
    C0023508 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    integer
    C0948762 (UMLS CUI [1])
    Basophils
    Item
    Basophils
    integer
    C0200641 (UMLS CUI [1])
    Eosinophils
    Item
    Eosinophils
    integer
    C0362902 (UMLS CUI [1])
    Lymphocytes
    Item
    Lymphocytes
    integer
    C0024264 (UMLS CUI [1])
    Monocytes
    Item
    Monocytes
    integer
    C0026473 (UMLS CUI [1])
    Other cells
    Item
    Other cells
    integer
    Platelets
    Item
    Platelets
    integer
    C0005821 (UMLS CUI [1])
    Prothrombin time
    Item
    Prothrombin time
    integer
    C0491338 (UMLS CUI [1])
    Comment
    Item
    Please comment on any abnormal other cells and specify white cell morphology
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Coombs tests indirect/direct
    Date
    Item
    Sample collection date
    date
    C1549498 (UMLS CUI [1])
    Item
    Indirect Coombs tests
    integer
    C0430262 (UMLS CUI [1])
    Code List
    Indirect Coombs tests
    CL Item
    negative (1)
    C0430263 (UMLS CUI-1)
    CL Item
    positive (2)
    C0151570 (UMLS CUI-1)
    Item
    Direct Coombs tests
    integer
    C0151569 (UMLS CUI [1])
    Code List
    Direct Coombs tests
    CL Item
    negative (1)
    C0430263 (UMLS CUI-1)
    CL Item
    positive (2)
    C0151570 (UMLS CUI-1)
    Item Group
    Blood chemistry
    C0005774 (UMLS CUI-1)
    AST (SGOT)
    Item
    Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
    integer
    C0004002 (UMLS CUI [1])
    ALT (SGPT)
    Item
    Alanine transaminase (Serum glutamate-pyruvate transaminase)
    integer
    C0001899 (UMLS CUI [1])
    Alk. phosphatase
    Item
    Alk. phosphatase
    integer
    C0002059 (UMLS CUI [1])
    Bilirubin total
    Item
    Bilirubin total
    text
    C0201913 (UMLS CUI-1)
    Urea (BUN)
    Item
    Urea (BUN)
    integer
    C0523961 (UMLS CUI [1])
    Serum creatinine
    Item
    Serum creatinine
    integer
    C0201976 (UMLS CUI [1])
    Estimated creatinine clearance
    Item
    Estimated creatinine clearance
    integer
    C0373595 (UMLS CUI [1])
    LDH
    Item
    Lactate dehydrogenase
    integer
    C0202113 (UMLS CUI [1])
    Total protein
    Item
    Total protein
    integer
    C0555903 (UMLS CUI [1])
    Albumin
    Item
    Albumin
    integer
    C0201838 (UMLS CUI [1])
    Blood glucose
    Item
    Blood glucose (random)
    integer
    C0202042 (UMLS CUI [1])
    beta-2-microglobulin
    Item
    beta-2-microglobulin
    integer
    C0201910 (UMLS CUI [1])
    Item Group
    Electrocytes
    Sodium
    Item
    Sodium
    integer
    C0337443 (UMLS CUI [1])
    Calcium
    Item
    Calcium
    integer
    C0201925 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    integer
    C0202194 (UMLS CUI [1])
    Phosphate
    Item
    Phosphate
    integer
    C0523826 (UMLS CUI [1])
    Item Group
    Lymphocyte immunophenotyping (local lab)
    Date
    Item
    Sample collection date
    date
    C0011008 (UMLS CUI [1])
    Lymphocytes
    Item
    Lymphocytes
    float
    C0200635 (UMLS CUI [1])
    Monocytes
    Item
    Monocytes
    float
    C0026473 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    float
    C0948762 (UMLS CUI [1])
    Item Group
    Lymphocyte immunophenotyping (local lab)
    Item
    Lymphocyte immunophenotyping Lab value
    integer
    C0079718 (UMLS CUI [1])
    Code List
    Lymphocyte immunophenotyping Lab value
    CL Item
    CD3+ (1)
    C1267816 (UMLS CUI-1)
    CL Item
    CD5+/CD19 (2)
    C0487156 (UMLS CUI-1)
    CL Item
    CD19+ (3)
    C0108748 (UMLS CUI-1)
    CL Item
    CD5+/CD20 (4)
    C1267847 (UMLS CUI-1)
    CL Item
    CD20+ (5)
    C0054946 (UMLS CUI-1)
    CL Item
    CD79b (6)
    C0104979 (UMLS CUI-1)
    CL Item
    CD23 (7)
    C0123242 (UMLS CUI-1)
    CL Item
    CD38 (8)
    C0075742 (UMLS CUI-1)
    CL Item
    FMC7/lgG1 (SMIG) weak (9)
    C0675491 (UMLS CUI-1)
    CL Item
    kappa (10)
    C0439099 (UMLS CUI-1)
    CL Item
    lambda (11)
    C1706314 (UMLS CUI-1)
    Item
    Lymphocyte immunophenotyping Lab parameter
    integer
    C0079718 (UMLS CUI [1])
    Code List
    Lymphocyte immunophenotyping Lab parameter
    CL Item
    gated (1)
    C0444699 (UMLS CUI-1)
    CL Item
    total (2)
    C0439810 (UMLS CUI-1)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI-1)
    Item Group
    Blood sampling for molecular analyses
    Item
    Sample number
    integer
    C0370003 (UMLS CUI [1])
    Code List
    Sample number
    CL Item
    Sample collection date (1)
    C1317250 (UMLS CUI-1)
    CL Item
    Remarks (2)
    C0947611 (UMLS CUI-1)
    Item Group
    Blood sampling for VH mutation status and chromosome abnormalities
    Item
    Sample number 401
    integer
    Code List
    Sample number 401
    CL Item
    Sample collection date (1)
    C1317250 (UMLS CUI-1)
    CL Item
    Remarks (2)
    C0947611 (UMLS CUI-1)
    Item Group
    Bone marrow examination
    C0005957 (UMLS CUI-1)
    Date
    Item
    Date of examination
    date
    C2826643 (UMLS CUI [1])
    Item Group
    Result of Bone marrow examination
    Result of Bone marrow examination normal result
    Item
    Result of Bone marrow examination normal result
    boolean
    C0427695 (UMLS CUI [1])
    Item
    Result of Bone marrow examination abnormal result
    integer
    C0427696 (UMLS CUI [1])
    Code List
    Result of Bone marrow examination abnormal result
    CL Item
    normocellular (1)
    C2960424 (UMLS CUI-1)
    CL Item
    hypocellular (2)
    C1855710 (UMLS CUI-1)
    CL Item
    hypercellular (3)
    C0542080 (UMLS CUI-1)
    Item Group
    Is bone marrow involved with CLL?
    Item
    Percentage of bone marrow involvement
    integer
    C1517677 (UMLS CUI [1])
    Code List
    Percentage of bone marrow involvement
    CL Item
    Percentage of bone marrow involved with CLL (1)
    C1517677 (UMLS CUI-1)
    CL Item
    diffuse pattern of involvement (2)
    C0205219 (UMLS CUI-1)
    CL Item
    nodular pattern of involvement (3)
    C1334972 (UMLS CUI-1)
    no involvement
    Item
    no involvement
    boolean
    C1517677 (UMLS CUI [1])
    Lymphoid nodules in bone marrow?
    Item
    Lymphoid nodules in bone marrow?
    boolean
    C3807548 (UMLS CUI [1])

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