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NCT00982111 · BASELINE

Baseline characteristics

First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer With Necitumumab (IMC-11F8) and Pemetrexed-Cisplatin · Source last updated 2022-01-11

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
      315
    2. group Id
      BG001
      value
      318
    3. group Id
      BG002
      value
      633
    units
    Participants
groups
  1. description
    Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    id
    BG000
    title
    Necitumumab + Pemetrexed + Cisplatin
  2. description
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    id
    BG001
    title
    Pemetrexed + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          84
          value
          61.0
        2. group Id
          BG001
          lower Limit
          34
          upper Limit
          88
          value
          60.0
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          88
          value
          61.00
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          209
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          424
        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
          47
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          93
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          540
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          590
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          24
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          52
      title
      Romania
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          45
      title
      Hungary
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      United States
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
      title
      Portugal
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          67
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
      title
      Greece
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Canada
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          19
      title
      Austria
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      Belgium
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          72
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          247
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          183
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          349
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          36
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active. 1 - Ambulatory, Restricted Strenuous Activity. 2 - Ambulatory, No Work Activities. 3 - Partially Confined to Bed, Limited Self Care. 4 - Completely Disabled. 5 - Death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          53
      title
      Ex-Light Smoker
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          104
      title
      Nonsmoker
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          476
      title
      Smoker
    param Type
    NUMBER
    title
    Smoking
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Stage IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          305
        2. group Id
          BG001
          value
          307
        3. group Id
          BG002
          value
          612
      title
      Stage IV
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
    param Type
    NUMBER
    title
    Disease Stage at Study Entry
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          307
        2. group Id
          BG001
          value
          311
        3. group Id
          BG002
          value
          618
      title
      Adenocarcinoma/Large Cell Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      Other
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Disease Histology
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          212
      title
      Bone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          52
      title
      Brain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          122
      title
      Liver
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          527
      title
      Lung
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          479
      title
      Lymph Nodes
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
      title
      Peritoneal
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          222
      title
      Pleural
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Skin
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          40
      title
      Soft Tissue
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          180
      title
      Other
    description
    Participants may record multiple sites of metastatic disease.
    param Type
    NUMBER
    title
    Sites of Metastatic Disease
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      315
    2. group Id
      BG001
      value
      318
    3. group Id
      BG002
      value
      633
    units
    Participants
groups
  1. description
    Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    id
    BG000
    title
    Necitumumab + Pemetrexed + Cisplatin
  2. description
    Pemetrexed + Cisplatin Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles
    id
    BG001
    title
    Pemetrexed + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          26
          upper Limit
          84
          value
          61.0
        2. group Id
          BG001
          lower Limit
          34
          upper Limit
          88
          value
          60.0
        3. group Id
          BG002
          lower Limit
          26
          upper Limit
          88
          value
          61.00
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          209
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          214
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          424
        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
          47
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          93
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          272
        3. group Id
          BG002
          value
          540
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          590
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          24
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
      title
      Russian Federation
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          52
      title
      Romania
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          45
      title
      Hungary
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      United States
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
      title
      United Kingdom
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
      title
      Portugal
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          67
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
      title
      Greece
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Canada
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          19
      title
      Austria
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      Belgium
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          72
      title
      Brazil
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          247
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          183
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          349
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          36
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active. 1 - Ambulatory, Restricted Strenuous Activity. 2 - Ambulatory, No Work Activities. 3 - Partially Confined to Bed, Limited Self Care. 4 - Completely Disabled. 5 - Death.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) at Baseline
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          53
      title
      Ex-Light Smoker
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          104
      title
      Nonsmoker
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          476
      title
      Smoker
    param Type
    NUMBER
    title
    Smoking
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Stage IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          305
        2. group Id
          BG001
          value
          307
        3. group Id
          BG002
          value
          612
      title
      Stage IV
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
    param Type
    NUMBER
    title
    Disease Stage at Study Entry
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          307
        2. group Id
          BG001
          value
          311
        3. group Id
          BG002
          value
          618
      title
      Adenocarcinoma/Large Cell Carcinoma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      Other
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    NUMBER
    title
    Disease Histology
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          103
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          212
      title
      Bone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          52
      title
      Brain
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          122
      title
      Liver
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          527
      title
      Lung
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          239
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          479
      title
      Lymph Nodes
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          43
      title
      Peritoneal
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          222
      title
      Pleural
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Skin
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          40
      title
      Soft Tissue
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          180
      title
      Other
    description
    Participants may record multiple sites of metastatic disease.
    param Type
    NUMBER
    title
    Sites of Metastatic Disease
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice