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NCT01761266 · BASELINE

Baseline characteristics

A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma · Source last updated 2022-04-05

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
      478
    2. group Id
      BG001
      value
      476
    3. group Id
      BG002
      value
      954
    units
    Participants
groups
  1. description
    Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    BG000
    title
    Lenvatinib
  2. description
    Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    BG001
    title
    Sorafenib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.69
          value
          61.3
        2. group Id
          BG001
          spread
          12.01
          value
          61.2
        3. group Id
          BG002
          spread
          11.84
          value
          61.3
    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
          73
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          148
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          405
        2. group Id
          BG001
          value
          401
        3. group Id
          BG002
          value
          806
        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
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          472
        2. group Id
          BG001
          value
          465
        3. group Id
          BG002
          value
          937
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          334
        2. group Id
          BG001
          value
          326
        3. group Id
          BG002
          value
          660
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          276
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The full analysis set (FAS) included all participants who were randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      478
    2. group Id
      BG001
      value
      476
    3. group Id
      BG002
      value
      954
    units
    Participants
groups
  1. description
    Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    BG000
    title
    Lenvatinib
  2. description
    Participants received sorafenib 400 mg tablets, orally, twice daily (BID) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
    id
    BG001
    title
    Sorafenib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.69
          value
          61.3
        2. group Id
          BG001
          spread
          12.01
          value
          61.2
        3. group Id
          BG002
          spread
          11.84
          value
          61.3
    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
          73
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          148
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          405
        2. group Id
          BG001
          value
          401
        3. group Id
          BG002
          value
          806
        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
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          472
        2. group Id
          BG001
          value
          465
        3. group Id
          BG002
          value
          937
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          334
        2. group Id
          BG001
          value
          326
        3. group Id
          BG002
          value
          660
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          135
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          276
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The full analysis set (FAS) included all participants who were randomized.

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

Preserved source evidence · Not medical advice