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NCT00113763 · BASELINE

Baseline characteristics

Evaluating Panitumumab (ABX-EGF) Plus Best Supportive Care Versus Best Supportive Care in Patients With Metastatic Colorectal Cancer · 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
      231
    2. group Id
      BG001
      value
      232
    3. group Id
      BG002
      value
      463
    units
    Participants
groups
  1. description
    Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
    id
    BG000
    title
    Panitumumab Plus BSC
  2. description
    Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
    id
    BG001
    title
    BSC Alone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.3
          value
          61.2
        2. group Id
          BG001
          spread
          10.8
          value
          61.4
        3. group Id
          BG002
          spread
          10.5
          value
          61.3
    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
          85
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          169
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          146
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          294
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Japanese
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Aborigine
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Other
    4. 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
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Asian
    6. categories
      1. 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
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Black or African American
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          228
        3. group Id
          BG002
          value
          457
      title
      White or Caucasian
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Hispanic or Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          39
      title
      Central and Eastern Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          358
      title
      Western Europe
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          66
      title
      Rest of World
    description
    Central and Eastern Europe includes the Czech Republic, Greece, Hungary, and the Slovak Republic. Rest of World includes Australia, Canada and New Zealand. Western Europe includes Austria, Belgium, France, Germany, Italy, Portugal, Spain, Switzerland, and the Netherlands.
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          202
        3. group Id
          BG002
          value
          402
      title
      0 or 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          61
      title
      2
    description
    Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 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
      231
    2. group Id
      BG001
      value
      232
    3. group Id
      BG002
      value
      463
    units
    Participants
groups
  1. description
    Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
    id
    BG000
    title
    Panitumumab Plus BSC
  2. description
    Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
    id
    BG001
    title
    BSC Alone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.3
          value
          61.2
        2. group Id
          BG001
          spread
          10.8
          value
          61.4
        3. group Id
          BG002
          spread
          10.5
          value
          61.3
    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
          85
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          169
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          146
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          294
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Japanese
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Aborigine
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Other
    4. 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
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Asian
    6. categories
      1. 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
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Black or African American
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          228
        3. group Id
          BG002
          value
          457
      title
      White or Caucasian
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Hispanic or Latino
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          39
      title
      Central and Eastern Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          178
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          358
      title
      Western Europe
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          66
      title
      Rest of World
    description
    Central and Eastern Europe includes the Czech Republic, Greece, Hungary, and the Slovak Republic. Rest of World includes Australia, Canada and New Zealand. Western Europe includes Austria, Belgium, France, Germany, Italy, Portugal, Spain, Switzerland, and the Netherlands.
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          202
        3. group Id
          BG002
          value
          402
      title
      0 or 1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          61
      title
      2
    description
    Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) performance status
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice