Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01905657 · BASELINE

Baseline characteristics

Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010) · Source last updated 2021-10-06

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
      345
    2. group Id
      BG001
      value
      346
    3. group Id
      BG002
      value
      343
    4. group Id
      BG003
      value
      1034
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
    id
    BG000
    title
    Pembrolizumab 2 mg/kg
  2. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
    id
    BG001
    title
    Pembrolizumab 10 mg/kg
  3. description
    Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
    id
    BG002
    title
    Docetaxel 75 mg/m^2
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.6
          value
          62.1
        2. group Id
          BG001
          spread
          9.7
          value
          62.3
        3. group Id
          BG002
          spread
          9.8
          value
          61.6
        4. group Id
          BG003
          spread
          9.7
          value
          62.0
    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
          132
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          134
        4. group Id
          BG003
          value
          399
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          209
        4. group Id
          BG003
          value
          635
        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
          206
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          191
        4. group Id
          BG003
          value
          592
        title
        Weakly PD-L1 Positive
      2. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          152
        4. group Id
          BG003
          value
          442
        title
        Strongly PD-L1 Positive
    description
    PD-L1 expression was evaluated by immunohistochemistry (IHC) assay with a newly obtained tumor tissue with biopsy. If PD-L1 expression was observed in ≥1%, but ≤49% of tumor cells, a participant was categorized as weakly PD-L1 positive. If PD-L1 expression was observed in ≥50% of tumor cells, a participant was categorized as strongly PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Tumor Expression Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      345
    2. group Id
      BG001
      value
      346
    3. group Id
      BG002
      value
      343
    4. group Id
      BG003
      value
      1034
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
    id
    BG000
    title
    Pembrolizumab 2 mg/kg
  2. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
    id
    BG001
    title
    Pembrolizumab 10 mg/kg
  3. description
    Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
    id
    BG002
    title
    Docetaxel 75 mg/m^2
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.6
          value
          62.1
        2. group Id
          BG001
          spread
          9.7
          value
          62.3
        3. group Id
          BG002
          spread
          9.8
          value
          61.6
        4. group Id
          BG003
          spread
          9.7
          value
          62.0
    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
          132
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          134
        4. group Id
          BG003
          value
          399
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          209
        4. group Id
          BG003
          value
          635
        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
          206
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          191
        4. group Id
          BG003
          value
          592
        title
        Weakly PD-L1 Positive
      2. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          152
        4. group Id
          BG003
          value
          442
        title
        Strongly PD-L1 Positive
    description
    PD-L1 expression was evaluated by immunohistochemistry (IHC) assay with a newly obtained tumor tissue with biopsy. If PD-L1 expression was observed in ≥1%, but ≤49% of tumor cells, a participant was categorized as weakly PD-L1 positive. If PD-L1 expression was observed in ≥50% of tumor cells, a participant was categorized as strongly PD-L1 positive.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Tumor Expression Status
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice