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NCT04209855 · BASELINE

Baseline characteristics

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression · Source last updated 2025-08-27

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
      227
    2. group Id
      BG001
      value
      226
    3. group Id
      BG002
      value
      453
    units
    Participants
groups
  1. description
    Participants received single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
    id
    BG000
    title
    Mirvetuximab Soravtansine
  2. description
    Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
    id
    BG001
    title
    Investigator's Choice (IC) Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.85
          value
          63.3
        2. group Id
          BG001
          spread
          9.30
          value
          62.3
        3. group Id
          BG002
          spread
          9.58
          value
          62.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          453
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          27
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          340
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          86
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          53
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          301
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          86
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      227
    2. group Id
      BG001
      value
      226
    3. group Id
      BG002
      value
      453
    units
    Participants
groups
  1. description
    Participants received single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
    id
    BG000
    title
    Mirvetuximab Soravtansine
  2. description
    Participants received a dose of IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
    id
    BG001
    title
    Investigator's Choice (IC) Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.85
          value
          63.3
        2. group Id
          BG001
          spread
          9.30
          value
          62.3
        3. group Id
          BG002
          spread
          9.58
          value
          62.8
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          227
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          453
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          27
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          177
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          340
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          86
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          53
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          301
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          86
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).

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Preserved source evidence · Not medical advice