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NCT03052608 · BASELINE

Baseline characteristics

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25

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
      149
    2. group Id
      BG001
      value
      147
    3. group Id
      BG002
      value
      296
    units
    Participants
groups
  1. description
    Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    BG000
    title
    Lorlatinib
  2. description
    Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    BG001
    title
    Crizotinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.12
          value
          59.1
        2. group Id
          BG001
          spread
          13.52
          value
          55.6
        3. group Id
          BG002
          spread
          13.41
          value
          57.4
    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
          84
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          175
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          121
        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
          72
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          144
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          130
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          21
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      149
    2. group Id
      BG001
      value
      147
    3. group Id
      BG002
      value
      296
    units
    Participants
groups
  1. description
    Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    BG000
    title
    Lorlatinib
  2. description
    Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    BG001
    title
    Crizotinib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.12
          value
          59.1
        2. group Id
          BG001
          spread
          13.52
          value
          55.6
        3. group Id
          BG002
          spread
          13.41
          value
          57.4
    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
          84
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          175
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          121
        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
          72
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          144
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          130
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          21
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice