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NCT01466179 · BASELINE

Baseline characteristics

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2017-08-18

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
      189
    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 up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
    id
    BG000
    title
    Blinatumomab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          79
          value
          39.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
      title
      18 to < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      title
      35 to < 55 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      55 to < 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          119
        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
          145
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      American Indian or Alaska native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Native Hawaiian or other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Not recorded
    description
    Race was not permitted to be collected in France
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Primary refractory
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      title
      Relapse ≤ 12 months of allogeneic HSCT
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Entering first salvage; first remission ≤ 12 mo
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          108
      title
      Entering second or greater salvage therapies
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No criteria met
    description
    HSCT = hematopoietic stem cell transplantation
    param Type
    NUMBER
    title
    Disease stage entry criteria met
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          107
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      >2
    param Type
    NUMBER
    title
    Number of prior relapses
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      Prior allogeneic HSCT
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      No prior alloHSCT, no prior relapse
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          84
      title
      No prior alloHSCT, 1 prior relapse
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      No prior alloHSCT, 2 prior relapses
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No prior alloHSCT, > 2 prior relapses
    description
    alloHSCT = allogeneic hematopoietic stem cell transplantation
    param Type
    NUMBER
    title
    Prior allogeneic HSCT and prior relapses
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
      title
      No prior salvage therapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          77
      title
      1 prior salvage therapy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
      title
      2 prior salvage therapies
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      > 2 prior salvage therapies
    param Type
    NUMBER
    title
    Number of prior salvage therapies
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.9
          upper Limit
          249.0
          value
          16.59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since initial diagnosis
    unit Of Measure
    months
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          56.8
          value
          1.38
    description
    Reported for 173 participants with a prior relapse (the other16 participants were primary refractory with no prior relapses).
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since last relapse
    unit Of Measure
    months
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      < 10%
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      10% - < 50%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          145
      title
      ≥ 50%
    description
    Bone marrow blasts were assessed by local and central laboratories; reported data are based on maximum central and local laboratory assessments.
    param Type
    NUMBER
    title
    Baseline bone marrow blast category
    unit Of Measure
    participants
population Description
Primary Analysis Set
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      189
    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 up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
    id
    BG000
    title
    Blinatumomab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          79
          value
          39.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
      title
      18 to < 35 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      title
      35 to < 55 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          28
      title
      55 to < 65 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      ≥ 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          119
        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
          145
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      American Indian or Alaska native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Native Hawaiian or other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Not recorded
    description
    Race was not permitted to be collected in France
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Primary refractory
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
      title
      Relapse ≤ 12 months of allogeneic HSCT
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
      title
      Entering first salvage; first remission ≤ 12 mo
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          108
      title
      Entering second or greater salvage therapies
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No criteria met
    description
    HSCT = hematopoietic stem cell transplantation
    param Type
    NUMBER
    title
    Disease stage entry criteria met
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          107
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          46
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      >2
    param Type
    NUMBER
    title
    Number of prior relapses
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
      title
      Prior allogeneic HSCT
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      No prior alloHSCT, no prior relapse
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          84
      title
      No prior alloHSCT, 1 prior relapse
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
      title
      No prior alloHSCT, 2 prior relapses
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      No prior alloHSCT, > 2 prior relapses
    description
    alloHSCT = allogeneic hematopoietic stem cell transplantation
    param Type
    NUMBER
    title
    Prior allogeneic HSCT and prior relapses
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
      title
      No prior salvage therapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          77
      title
      1 prior salvage therapy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
      title
      2 prior salvage therapies
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      > 2 prior salvage therapies
    param Type
    NUMBER
    title
    Number of prior salvage therapies
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.9
          upper Limit
          249.0
          value
          16.59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since initial diagnosis
    unit Of Measure
    months
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          56.8
          value
          1.38
    description
    Reported for 173 participants with a prior relapse (the other16 participants were primary refractory with no prior relapses).
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time since last relapse
    unit Of Measure
    months
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      < 10%
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
      title
      10% - < 50%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          145
      title
      ≥ 50%
    description
    Bone marrow blasts were assessed by local and central laboratories; reported data are based on maximum central and local laboratory assessments.
    param Type
    NUMBER
    title
    Baseline bone marrow blast category
    unit Of Measure
    participants
population Description
Primary Analysis Set

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Preserved source evidence · Not medical advice