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NCT02000427 · BASELINE

Baseline characteristics

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia · Source last updated 2024-05-28

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
      45
    units
    Participants
groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
    id
    BG000
    title
    Blinatumomab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.0
          value
          52.8
    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
          5
      title
      18 to < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      35 to < 55 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      55 to < 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          39
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Black (or African American)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Hispanic/Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      Not Hispanic/Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      1 TKI
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      2 TKIs
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      3 TKIs
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      4 TKIs
    param Type
    NUMBER
    title
    Prior Tyrosine Kinase Inhibitor (TKI) Treatment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No relapses
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      1 relapse
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      2 relapses
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      ≥ 3 relapses
    param Type
    NUMBER
    title
    Number of Prior Relapses
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      0 regimens
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      1 regimen
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      2 regimens
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      ≥ 3 regimens
    param Type
    NUMBER
    title
    Number of Prior Salvage Regimens
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      No
    param Type
    NUMBER
    title
    Prior Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          26.1
          value
          27.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time From Initial Diagnosis
    unit Of Measure
    months
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      45
    units
    Participants
groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
    id
    BG000
    title
    Blinatumomab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.0
          value
          52.8
    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
          5
      title
      18 to < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      35 to < 55 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      55 to < 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        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
          39
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Black (or African American)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Hispanic/Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      Not Hispanic/Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      1 TKI
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
      title
      2 TKIs
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      3 TKIs
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      4 TKIs
    param Type
    NUMBER
    title
    Prior Tyrosine Kinase Inhibitor (TKI) Treatment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No relapses
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      1 relapse
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      2 relapses
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      ≥ 3 relapses
    param Type
    NUMBER
    title
    Number of Prior Relapses
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      0 regimens
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      1 regimen
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      2 regimens
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      ≥ 3 regimens
    param Type
    NUMBER
    title
    Number of Prior Salvage Regimens
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      No
    param Type
    NUMBER
    title
    Prior Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          26.1
          value
          27.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time From Initial Diagnosis
    unit Of Measure
    months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice