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NCT00873093 · BASELINE

Baseline characteristics

Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma · Source last updated 2017-01-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      62
    3. group Id
      BG002
      value
      49
    4. group Id
      BG003
      value
      23
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      148
    units
    Participants
groups
  1. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG000
    title
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
  2. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG001
    title
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
  3. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG002
    title
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
  4. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG003
    title
    T-cell ALL (Chemotherapy)
  5. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG004
    title
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          126
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          22
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.57
          value
          23.14
        2. group Id
          BG001
          spread
          5.77
          value
          10.16
        3. group Id
          BG002
          spread
          6.06
          value
          9.27
        4. group Id
          BG003
          spread
          5.28
          value
          13.00
        5. group Id
          BG004
          spread
          6.27
          value
          13.79
        6. group Id
          BG005
          spread
          6.23
          value
          10.91
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          85
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          38
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          107
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          104
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      62
    3. group Id
      BG002
      value
      49
    4. group Id
      BG003
      value
      23
    5. group Id
      BG004
      value
      10
    6. group Id
      BG005
      value
      148
    units
    Participants
groups
  1. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG000
    title
    Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs
  2. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG001
    title
    Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs
  3. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG002
    title
    Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs
  4. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG003
    title
    T-cell ALL (Chemotherapy)
  5. description
    Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \& 11 of Block 1 and days 1, 4, \& 8 of Block 2.
    id
    BG004
    title
    T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          126
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          22
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.57
          value
          23.14
        2. group Id
          BG001
          spread
          5.77
          value
          10.16
        3. group Id
          BG002
          spread
          6.06
          value
          9.27
        4. group Id
          BG003
          spread
          5.28
          value
          13.00
        5. group Id
          BG004
          spread
          6.27
          value
          13.79
        6. group Id
          BG005
          spread
          6.23
          value
          10.91
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          63
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          85
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          38
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          107
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          22
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          104
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice