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NCT00339183 · BASELINE

Baseline characteristics

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone · Source last updated 2022-09-23

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
      591
    2. group Id
      BG001
      value
      595
    3. group Id
      BG002
      value
      1186
    units
    Participants
groups
  1. description
    Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
    id
    BG000
    title
    Panitumumab Plus FOLFIRI
  2. description
    Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
    id
    BG001
    title
    FOLFIRI Alone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.5
          value
          60.2
        2. group Id
          BG001
          spread
          10.6
          value
          60.9
        3. group Id
          BG002
          spread
          10.5
          value
          60.6
    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
          245
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          464
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          346
        2. group Id
          BG001
          value
          376
        3. group Id
          BG002
          value
          722
        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
          568
        2. group Id
          BG001
          value
          569
        3. group Id
          BG002
          value
          1137
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Japanese
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Aborigine
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          303
        2. group Id
          BG001
          value
          294
        3. group Id
          BG002
          value
          597
      title
      Wild-type KRAS
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          248
        3. group Id
          BG002
          value
          486
      title
      Mutant KRAS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          103
      title
      Unevaluable KRAS
    description
    KRAS, the human homolog of the Kirsten rat sarcoma-2 virus oncogene
    param Type
    NUMBER
    title
    KRAS Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          361
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          412
        2. group Id
          BG001
          value
          413
        3. group Id
          BG002
          value
          825
      title
      Yes
    description
    mCRC: metastatic colorectal cancer
    param Type
    NUMBER
    title
    Prior Oxaliplatin Exposure for mCRC
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          480
        2. group Id
          BG001
          value
          483
        3. group Id
          BG002
          value
          963
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          112
        3. group Id
          BG002
          value
          223
      title
      Yes
    param Type
    NUMBER
    title
    Prior Bevacizumab Exposure for mCRC
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          564
        2. group Id
          BG001
          value
          565
        3. group Id
          BG002
          value
          1129
      title
      Grade 0 or 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          57
      title
      Grade 2
    description
    Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; Grade 3: Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5: Dead
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      591
    2. group Id
      BG001
      value
      595
    3. group Id
      BG002
      value
      1186
    units
    Participants
groups
  1. description
    Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
    id
    BG000
    title
    Panitumumab Plus FOLFIRI
  2. description
    Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
    id
    BG001
    title
    FOLFIRI Alone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.5
          value
          60.2
        2. group Id
          BG001
          spread
          10.6
          value
          60.9
        3. group Id
          BG002
          spread
          10.5
          value
          60.6
    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
          245
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          464
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          346
        2. group Id
          BG001
          value
          376
        3. group Id
          BG002
          value
          722
        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
          568
        2. group Id
          BG001
          value
          569
        3. group Id
          BG002
          value
          1137
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Japanese
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Aborigine
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          303
        2. group Id
          BG001
          value
          294
        3. group Id
          BG002
          value
          597
      title
      Wild-type KRAS
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          248
        3. group Id
          BG002
          value
          486
      title
      Mutant KRAS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          103
      title
      Unevaluable KRAS
    description
    KRAS, the human homolog of the Kirsten rat sarcoma-2 virus oncogene
    param Type
    NUMBER
    title
    KRAS Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          182
        3. group Id
          BG002
          value
          361
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          412
        2. group Id
          BG001
          value
          413
        3. group Id
          BG002
          value
          825
      title
      Yes
    description
    mCRC: metastatic colorectal cancer
    param Type
    NUMBER
    title
    Prior Oxaliplatin Exposure for mCRC
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          480
        2. group Id
          BG001
          value
          483
        3. group Id
          BG002
          value
          963
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          112
        3. group Id
          BG002
          value
          223
      title
      Yes
    param Type
    NUMBER
    title
    Prior Bevacizumab Exposure for mCRC
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          564
        2. group Id
          BG001
          value
          565
        3. group Id
          BG002
          value
          1129
      title
      Grade 0 or 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          57
      title
      Grade 2
    description
    Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; Grade 3: Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; Grade 5: Dead
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice