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NCT00364013 · BASELINE

Baseline characteristics

PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy · Source last updated 2022-11-07

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
      593
    2. group Id
      BG001
      value
      590
    3. group Id
      BG002
      value
      1183
    units
    Participants
groups
  1. description
    Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
    id
    BG000
    title
    FOLFOX + Panitumumab
  2. description
    Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
    id
    BG001
    title
    FOLFOX Alone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.1
          value
          61.5
        2. group Id
          BG001
          spread
          11.0
          value
          60.3
        3. group Id
          BG002
          spread
          10.6
          value
          60.9
    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
          207
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          439
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          386
        2. group Id
          BG001
          value
          358
        3. group Id
          BG002
          value
          744
        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
          530
        2. group Id
          BG001
          value
          540
        3. group Id
          BG002
          value
          1070
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          23
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          68
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          661
      title
      Western Europe, Canada and Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          522
      title
      Rest of world
    description
    Stratification factor. Rest of world includes South America, eastern Europe, South Africa and Mexico
    param Type
    NUMBER
    title
    Geographic Region
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          325
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          656
      title
      Wild-type KRAS
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          221
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          440
      title
      Mutant KRAS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          87
      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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          652
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          468
      title
      Grade 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          60
      title
      Grade 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Grade 3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Grade 4
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Mising/Unknown
    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
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          394
        2. group Id
          BG001
          value
          398
        3. group Id
          BG002
          value
          792
      title
      Colon cancer
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          391
      title
      Rectal cancer
    param Type
    NUMBER
    title
    Primary tumor type
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      593
    2. group Id
      BG001
      value
      590
    3. group Id
      BG002
      value
      1183
    units
    Participants
groups
  1. description
    Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
    id
    BG000
    title
    FOLFOX + Panitumumab
  2. description
    Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
    id
    BG001
    title
    FOLFOX Alone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.1
          value
          61.5
        2. group Id
          BG001
          spread
          11.0
          value
          60.3
        3. group Id
          BG002
          spread
          10.6
          value
          60.9
    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
          207
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          439
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          386
        2. group Id
          BG001
          value
          358
        3. group Id
          BG002
          value
          744
        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
          530
        2. group Id
          BG001
          value
          540
        3. group Id
          BG002
          value
          1070
      title
      White or Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          23
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          68
      title
      Hispanic or Latino
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          10
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          661
      title
      Western Europe, Canada and Australia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          261
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          522
      title
      Rest of world
    description
    Stratification factor. Rest of world includes South America, eastern Europe, South Africa and Mexico
    param Type
    NUMBER
    title
    Geographic Region
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          325
        2. group Id
          BG001
          value
          331
        3. group Id
          BG002
          value
          656
      title
      Wild-type KRAS
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          221
        2. group Id
          BG001
          value
          219
        3. group Id
          BG002
          value
          440
      title
      Mutant KRAS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          87
      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
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          332
        2. group Id
          BG001
          value
          320
        3. group Id
          BG002
          value
          652
      title
      Grade 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          468
      title
      Grade 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          60
      title
      Grade 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Grade 3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Grade 4
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Mising/Unknown
    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
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          394
        2. group Id
          BG001
          value
          398
        3. group Id
          BG002
          value
          792
      title
      Colon cancer
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          391
      title
      Rectal cancer
    param Type
    NUMBER
    title
    Primary tumor type
    unit Of Measure
    participants

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

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