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NCT01327885 · BASELINE

Baseline characteristics

Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma · Source last updated 2023-06-22

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
      228
    2. group Id
      BG001
      value
      224
    3. group Id
      BG002
      value
      452
    units
    Participants
groups
  1. description
    Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
    id
    BG000
    title
    Arm A: Eribulin Mesylate
  2. description
    Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
    id
    BG001
    title
    Arm B: Dacarbazine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.01
          value
          55.6
        2. group Id
          BG001
          spread
          10.35
          value
          55.7
        3. group Id
          BG002
          spread
          10.68
          value
          55.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    GEOMETRIC_MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          303
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          149
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      228
    2. group Id
      BG001
      value
      224
    3. group Id
      BG002
      value
      452
    units
    Participants
groups
  1. description
    Eribulin mesylate at a dose of 1.4 mg/m\^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
    id
    BG000
    title
    Arm A: Eribulin Mesylate
  2. description
    Dacarbazine at a dose of 850 mg/m\^2, 1000 mg/m\^2, or 1200 mg/m\^2 (as selected by the Principal Investigator \[PI\] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
    id
    BG001
    title
    Arm B: Dacarbazine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.01
          value
          55.6
        2. group Id
          BG001
          spread
          10.35
          value
          55.7
        3. group Id
          BG002
          spread
          10.68
          value
          55.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    GEOMETRIC_MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          303
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          67
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          149
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.

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

Preserved source evidence · Not medical advice