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NCT04697628 · BASELINE

Baseline characteristics

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer · Source last updated 2026-02-24

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
      253
    2. group Id
      BG001
      value
      249
    3. group Id
      BG002
      value
      502
    units
    Participants
groups
  1. description
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    id
    BG000
    title
    Tisotumab Vedotin
  2. description
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          51.9
        2. group Id
          BG001
          spread
          11.6
          value
          51.0
        3. group Id
          BG002
          spread
          11.7
          value
          51.4
    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
          253
        2. group Id
          BG001
          value
          249
        3. group Id
          BG002
          value
          502
        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
          122
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          244
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          180
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        title
        American Indian or Alaska Native
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      7. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        title
        Not Reported
      8. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Unknown
      title
      Race
    description
    Race is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          353
        title
        Not of Hispanic or Latino/a, or Spanish Origin
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          102
        title
        Hispanic or Latino/a, or of Spanish Origin
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Unknown
      title
      Ethinicity
    description
    Ethnicity is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      253
    2. group Id
      BG001
      value
      249
    3. group Id
      BG002
      value
      502
    units
    Participants
groups
  1. description
    Participants with rCC/mCC were administered tisotumab vedotin 2.0 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once every 3 weeks (Q3W).
    id
    BG000
    title
    Tisotumab Vedotin
  2. description
    Participants with rCC/mCC were treated with investigator's choice of chemotherapy which included either topotecan 1 or 1.25 milligram per meter square \[mg/m\^2\] IV on Days 1 to 5, every 21 days or vinorelbine 30 mg/m\^2 IV on Days 1 and 8, every 21 days or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8, every 21 days or irinotecan 100 or 125 mg/m\^2 IV weekly for 28 days, every 42 days or pemetrexed 500 mg/m\^2 on Day 1, every 21 days.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.8
          value
          51.9
        2. group Id
          BG001
          spread
          11.6
          value
          51.0
        3. group Id
          BG002
          spread
          11.7
          value
          51.4
    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
          253
        2. group Id
          BG001
          value
          249
        3. group Id
          BG002
          value
          502
        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
          122
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          244
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          180
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        title
        American Indian or Alaska Native
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Other
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      7. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        title
        Not Reported
      8. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Unknown
      title
      Race
    description
    Race is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          177
        3. group Id
          BG002
          value
          353
        title
        Not of Hispanic or Latino/a, or Spanish Origin
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          102
        title
        Hispanic or Latino/a, or of Spanish Origin
      3. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Unknown
      title
      Ethinicity
    description
    Ethnicity is reported.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) analysis set included all randomized participants. Participants were included in the treatment group assigned at randomization regardless of any actual treatment received.

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Preserved source evidence · Not medical advice