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NCT01866319 · BASELINE

Baseline characteristics

Study to Evaluate the Safety and Efficacy of Two Different Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Participants With Advanced Melanoma (MK-3475-006/KEYNOTE-006) · Source last updated 2020-06-02

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
      278
    2. group Id
      BG001
      value
      279
    3. group Id
      BG002
      value
      277
    4. group Id
      BG003
      value
      834
    units
    Participants
groups
  1. description
    Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
    id
    BG000
    title
    Ipilimumab
  2. description
    Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
    id
    BG001
    title
    Pembrolizumab Q2W
  3. description
    Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
    id
    BG002
    title
    Pembrolizumab Q3W
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.2
          value
          59.9
        2. group Id
          BG001
          spread
          14.6
          value
          59.9
        3. group Id
          BG002
          spread
          13.6
          value
          61.2
        4. group Id
          BG003
          spread
          14.1
          value
          60.3
    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
          116
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          337
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          497
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) population consisted of all randomized participants. Participants were included in the group to which they were randomized for Baseline Characteristics.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      278
    2. group Id
      BG001
      value
      279
    3. group Id
      BG002
      value
      277
    4. group Id
      BG003
      value
      834
    units
    Participants
groups
  1. description
    Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).
    id
    BG000
    title
    Ipilimumab
  2. description
    Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.
    id
    BG001
    title
    Pembrolizumab Q2W
  3. description
    Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.
    id
    BG002
    title
    Pembrolizumab Q3W
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.2
          value
          59.9
        2. group Id
          BG001
          spread
          14.6
          value
          59.9
        3. group Id
          BG002
          spread
          13.6
          value
          61.2
        4. group Id
          BG003
          spread
          14.1
          value
          60.3
    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
          116
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          337
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          162
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          174
        4. group Id
          BG003
          value
          497
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) population consisted of all randomized participants. Participants were included in the group to which they were randomized for Baseline Characteristics.

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Preserved source evidence · Not medical advice