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NCT02013167 · BASELINE

Baseline characteristics

Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) · Source last updated 2024-03-05

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
      134
    2. group Id
      BG001
      value
      271
    3. group Id
      BG002
      value
      405
    units
    Participants
groups
  1. description
    Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months.
    id
    BG000
    title
    Standard of Care Chemotherapy
  2. description
    Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.
    id
    BG001
    title
    Blinatumomab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.3
          value
          41.1
        2. group Id
          BG001
          spread
          17.1
          value
          40.8
        3. group Id
          BG002
          spread
          17.2
          value
          40.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          184
      title
      < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          113
      title
      35 to 54 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          60
      title
      55 to 64 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          48
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          166
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          239
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          365
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          28
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          228
        3. group Id
          BG002
          value
          340
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Multiple
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          183
      title
      < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          222
      title
      ≥ 35 years
    param Type
    NUMBER
    title
    Age Stratification at Randomization
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          244
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          161
      title
      No
    param Type
    NUMBER
    title
    Prior Salvage Therapy Stratification at Randomization
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          140
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          265
      title
      No
    param Type
    NUMBER
    title
    Prior Allogeneic Hematopoietic Stem Cell Transplant (HCST)
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          56
      title
      FLAG ± anthracycline
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          30
      title
      High-dose methotrexate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          26
      title
      Clofarabine
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          22
      title
      HIDAC
    description
    FLAG = fludarabine, cytarabine arabinoside, and granulocyte colony-stimulating factor (filgrastim); HiDAC = high-dose cytarabine arabinoside
    param Type
    NUMBER
    title
    Standard of Care Chemotherapy Regimen Received
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      134
    2. group Id
      BG001
      value
      271
    3. group Id
      BG002
      value
      405
    units
    Participants
groups
  1. description
    Participants received one of four prespecified, investigator-chosen chemotherapy regimens for 2 induction cycles. Participants who achieved a bone marrow response, CR/CRh\*/CRi within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of SOC chemotherapy. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive SOC therapy for an additional 12 months.
    id
    BG000
    title
    Standard of Care Chemotherapy
  2. description
    Participants received blinatumomab by continuous intravenous infusion (CIVI) over 4 weeks followed by a 2 week treatment-free interval for 2 induction cycles. Participants who achieved a bone marrow response, complete remission, or complete remission with partial or incomplete hematologic recovery (CR/CRh\*/CRi) within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. Participants who received 2 induction and up to 3 consolidation cycles of therapy and continued to have a bone marrow response or CR/CRh\*/CRi could continue to receive blinatumomab for an additional 12 months (4 cycles), where 1 cycle consisted of 4 weeks of CIVI followed by an 8-week treatment-free period. The initial dose of blinatumomab was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 through day 29 and for all subsequent cycles.
    id
    BG001
    title
    Blinatumomab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.3
          value
          41.1
        2. group Id
          BG001
          spread
          17.1
          value
          40.8
        3. group Id
          BG002
          spread
          17.2
          value
          40.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          184
      title
      < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          113
      title
      35 to 54 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          60
      title
      55 to 64 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          48
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          166
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          162
        3. group Id
          BG002
          value
          239
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          37
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          365
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          28
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          228
        3. group Id
          BG002
          value
          340
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Multiple
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          20
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          183
      title
      < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          222
      title
      ≥ 35 years
    param Type
    NUMBER
    title
    Age Stratification at Randomization
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          244
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          161
      title
      No
    param Type
    NUMBER
    title
    Prior Salvage Therapy Stratification at Randomization
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          140
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          265
      title
      No
    param Type
    NUMBER
    title
    Prior Allogeneic Hematopoietic Stem Cell Transplant (HCST)
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          56
      title
      FLAG ± anthracycline
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          30
      title
      High-dose methotrexate
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          26
      title
      Clofarabine
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          22
      title
      HIDAC
    description
    FLAG = fludarabine, cytarabine arabinoside, and granulocyte colony-stimulating factor (filgrastim); HiDAC = high-dose cytarabine arabinoside
    param Type
    NUMBER
    title
    Standard of Care Chemotherapy Regimen Received
    unit Of Measure
    participants

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