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NCT04154189 · BASELINE

Baseline characteristics

A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma · Source last updated 2024-07-22

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
      40
    2. group Id
      BG001
      value
      41
    3. group Id
      BG002
      value
      81
    units
    Participants
groups
  1. description
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    id
    BG000
    title
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
  2. description
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    id
    BG001
    title
    Treatment Arm B: Ifosfamide + Etoposide
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.76
          value
          15.6
        2. group Id
          BG001
          spread
          4.16
          value
          14.3
        3. group Id
          BG002
          spread
          3.99
          value
          14.9
    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
          15
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          35
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          46
        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
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          71
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          50
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaskan Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) included all randomized participants regardless of the treatment actually received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    2. group Id
      BG001
      value
      41
    3. group Id
      BG002
      value
      81
    units
    Participants
groups
  1. description
    Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
    id
    BG000
    title
    Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
  2. description
    Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
    id
    BG001
    title
    Treatment Arm B: Ifosfamide + Etoposide
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.76
          value
          15.6
        2. group Id
          BG001
          spread
          4.16
          value
          14.3
        3. group Id
          BG002
          spread
          3.99
          value
          14.9
    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
          15
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          35
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          46
        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
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          71
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          50
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      American Indian or Alaskan Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) included all randomized participants regardless of the treatment actually received.

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

Preserved source evidence · Not medical advice