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NCT00065442 · BASELINE

Baseline characteristics

Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy · Source last updated 2010-09-06

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
      171
    2. group Id
      BG001
      value
      341
    3. group Id
      BG002
      value
      512
    units
    Participants
groups
  1. description
    All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
    id
    BG000
    title
    APC-Placebo
  2. description
    All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
    id
    BG001
    title
    Sipuleucel-T
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.0
          value
          70.1
        2. group Id
          BG001
          spread
          8.9
          value
          71.1
        3. group Id
          BG002
          spread
          8.9
          value
          70.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          89
          value
          70
        2. group Id
          BG001
          lower Limit
          49
          upper Limit
          91
          value
          72
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          91
          value
          71
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          341
        3. group Id
          BG002
          value
          512
        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
      171
    2. group Id
      BG001
      value
      341
    3. group Id
      BG002
      value
      512
    units
    Participants
groups
  1. description
    All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
    id
    BG000
    title
    APC-Placebo
  2. description
    All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
    id
    BG001
    title
    Sipuleucel-T
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.0
          value
          70.1
        2. group Id
          BG001
          spread
          8.9
          value
          71.1
        3. group Id
          BG002
          spread
          8.9
          value
          70.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          89
          value
          70
        2. group Id
          BG001
          lower Limit
          49
          upper Limit
          91
          value
          72
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          91
          value
          71
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          341
        3. group Id
          BG002
          value
          512
        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