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NCT01849874 · BASELINE

Baseline characteristics

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer · Source last updated 2023-10-30

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
      106
    3. group Id
      BG002
      value
      333
    units
    Participants
groups
  1. description
    Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
    id
    BG000
    title
    MEK162
  2. description
    Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
    id
    BG001
    title
    Physician's Choice
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.64
          value
          52.26
        2. group Id
          BG001
          spread
          13.35
          value
          50.12
        3. group Id
          BG002
          spread
          14.26
          value
          51.58
    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
          106
        3. group Id
          BG002
          value
          333
        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
          18
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          27
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          295
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline analysis population included all participants in the safety population. Safety population consisted of all participants who received at any dose of study intervention (MEK162 or physician's choice chemotherapy).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      227
    2. group Id
      BG001
      value
      106
    3. group Id
      BG002
      value
      333
    units
    Participants
groups
  1. description
    Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
    id
    BG000
    title
    MEK162
  2. description
    Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.
    id
    BG001
    title
    Physician's Choice
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.64
          value
          52.26
        2. group Id
          BG001
          spread
          13.35
          value
          50.12
        3. group Id
          BG002
          spread
          14.26
          value
          51.58
    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
          106
        3. group Id
          BG002
          value
          333
        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
          18
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          27
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          295
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
population Description
Baseline analysis population included all participants in the safety population. Safety population consisted of all participants who received at any dose of study intervention (MEK162 or physician's choice chemotherapy).

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Preserved source evidence · Not medical advice