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NCT00648739 · BASELINE

Baseline characteristics

Safety and Dose Ranging Study of Samalizumab to Treat Relapsing or Refractory CLL or MM · Source last updated 2019-03-05

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
      26
    units
    Participants
groups
  1. description
    All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
    id
    BG000
    title
    Samalizumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.14
          value
          65.8629
    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
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        B-Cell Chronic Lymphocytic Leukemia
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Multiple Myeloma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of Malignancy
    unit Of Measure
    Participants
population Description
All participants who received at least 1 dose of samalizumab.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      26
    units
    Participants
groups
  1. description
    All doses of samalizumab were individualized based on the participant's body surface area in mg/m\^2 based on screening height and weight. Participants were assigned to a dose cohort, ranging from 50 to 600 mg/m\^2, and received a single IV dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
    id
    BG000
    title
    Samalizumab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.14
          value
          65.8629
    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
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        B-Cell Chronic Lymphocytic Leukemia
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Multiple Myeloma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of Malignancy
    unit Of Measure
    Participants
population Description
All participants who received at least 1 dose of samalizumab.

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Preserved source evidence · Not medical advice