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NCT01564784 · BASELINE

Baseline characteristics

A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia · Source last updated 2019-01-09

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
      164
    2. group Id
      BG001
      value
      143
    3. group Id
      BG002
      value
      307
    units
    Participants
groups
  1. description
    Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
    id
    BG000
    title
    Inotuzumab Ozogamicin
  2. description
    Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
    id
    BG001
    title
    Defined Investigator's Choice of Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.07
          value
          45.9
        2. group Id
          BG001
          spread
          16.32
          value
          45.6
        3. group Id
          BG002
          spread
          16.70
          value
          45.7
    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
          73
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          124
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          183
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      164
    2. group Id
      BG001
      value
      143
    3. group Id
      BG002
      value
      307
    units
    Participants
groups
  1. description
    Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).
    id
    BG000
    title
    Inotuzumab Ozogamicin
  2. description
    Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.
    id
    BG001
    title
    Defined Investigator's Choice of Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.07
          value
          45.9
        2. group Id
          BG001
          spread
          16.32
          value
          45.6
        3. group Id
          BG002
          spread
          16.70
          value
          45.7
    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
          73
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          124
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          183
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice