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NCT01139775 · BASELINE

Baseline characteristics

A Study in Non Small Cell Lung Cancer · Source last updated 2018-05-18

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
      14
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      23
    4. group Id
      BG003
      value
      76
    units
    Participants
groups
  1. description
    Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    BG000
    title
    Phase 1: Pemetrexed + Cisplatin + LY2603618
  2. description
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    BG001
    title
    Phase 2: Pemetrexed + Cisplatin + LY2603618
  3. description
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    id
    BG002
    title
    Phase 2: Pemetrexed + Cisplatin
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          57.9
        2. group Id
          BG001
          spread
          10.1
          value
          57.9
        3. group Id
          BG002
          spread
          9.8
          value
          56.4
        4. group Id
          BG003
          spread
          10.1
          value
          57.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          46
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          76
      title
      White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          43
      title
      Spain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          33
      title
      Germany
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Adenocarcinoma, Bronchiolalveolar
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Adenocarcinoma, Colon
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          65
      title
      Adenocarcinoma, Lung
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Adenocarcinoma, Moderately Diff., Lung
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Ampulla of Vater
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Breast
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Large Cell, Lung
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Lung
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Non-small Cell, Poorly Diff, Lung
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Pancreas
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Mesothelioma, Malignum
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Pleuritis Carcinomatosa
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Initial Pathological Diagnosis
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          27
      title
      ECOG Status 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          48
      title
      ECOG Status 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Missing
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death) as follows: 0 - Fully Active; 1 - Ambulatory, Restricted Strenuous Activity; 2 - Ambulatory, No Work Activities; 3 - Partially Confined to Bed, Limited Self Care; 4 - Completely Disabled; and 5 - Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
All participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      14
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      23
    4. group Id
      BG003
      value
      76
    units
    Participants
groups
  1. description
    Cycles 1-2 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 130 to 275 mg After 2 cycles, participants may have continued on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    BG000
    title
    Phase 1: Pemetrexed + Cisplatin + LY2603618
  2. description
    Cycles 1-4 (21-day cycle): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Before 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 Day 2: LY2603618 dose determined from phase 1 (275 mg) After 25 Oct 2012: Day 1: pemetrexed 500 mg/m\^2 If, as of 25 Oct 2012, the participant was in maintenance therapy and randomized to the experimental arm, the participant was eligible to continue with pemetrexed/LY2603618 therapy if the investigator deemed it was in the participant's best interest and the participant consented. Pemetrexed, cisplatin, and LY2603618 were administered IV over 10 minutes, 1 hour, and 1 hour, respectively.
    id
    BG001
    title
    Phase 2: Pemetrexed + Cisplatin + LY2603618
  3. description
    Cycles 1-4 (21-day cycle): Day 1: pemetrexed 500 mg/m\^2 + cisplatin 75 mg/m\^2 After 4 cycles, participants may have continued on maintenance therapy until disease progression, unacceptable toxicity, or other withdrawal criterion was met. Maintenance therapy (every 21 days): Day 1: pemetrexed 500 mg/m\^2 Pemetrexed was administered IV over 10 minutes, and cisplatin was administered IV over 1 hour.
    id
    BG002
    title
    Phase 2: Pemetrexed + Cisplatin
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          57.9
        2. group Id
          BG001
          spread
          10.1
          value
          57.9
        3. group Id
          BG002
          spread
          9.8
          value
          56.4
        4. group Id
          BG003
          spread
          10.1
          value
          57.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          46
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          76
      title
      White
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          43
      title
      Spain
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          33
      title
      Germany
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Adenocarcinoma, Bronchiolalveolar
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Adenocarcinoma, Colon
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          65
      title
      Adenocarcinoma, Lung
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Adenocarcinoma, Moderately Diff., Lung
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Ampulla of Vater
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Breast
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Large Cell, Lung
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Lung
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Non-small Cell, Poorly Diff, Lung
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Carcinoma, Pancreas
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Mesothelioma, Malignum
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Pleuritis Carcinomatosa
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Initial Pathological Diagnosis
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          27
      title
      ECOG Status 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          48
      title
      ECOG Status 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Missing
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death) as follows: 0 - Fully Active; 1 - Ambulatory, Restricted Strenuous Activity; 2 - Ambulatory, No Work Activities; 3 - Partially Confined to Bed, Limited Self Care; 4 - Completely Disabled; and 5 - Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
All participants.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice