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NCT00045032 · BASELINE

Baseline characteristics

Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer · Source last updated 2017-04-27

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
      1697
    2. group Id
      BG001
      value
      1702
    3. group Id
      BG002
      value
      1700
    4. group Id
      BG003
      value
      5099
    units
    Participants
groups
  1. description
    Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
    id
    BG000
    title
    Observation Arm
  2. description
    Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
    id
    BG001
    title
    Herceptin 1-Year Arm
  3. description
    Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
    id
    BG002
    title
    Herceptin 2-Year Arm
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.08
          value
          49.2
        2. group Id
          BG001
          spread
          10.06
          value
          49.0
        3. group Id
          BG002
          spread
          10.09
          value
          49.2
        4. group Id
          BG003
          spread
          10.08
          value
          49.1
    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
          1697
        2. group Id
          BG001
          value
          1702
        3. group Id
          BG002
          value
          1700
        4. group Id
          BG003
          value
          5099
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) Population: All enrolled/randomized participants who had an available signed Informed Consent Form.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1697
    2. group Id
      BG001
      value
      1702
    3. group Id
      BG002
      value
      1700
    4. group Id
      BG003
      value
      5099
    units
    Participants
groups
  1. description
    Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.
    id
    BG000
    title
    Observation Arm
  2. description
    Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
    id
    BG001
    title
    Herceptin 1-Year Arm
  3. description
    Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.
    id
    BG002
    title
    Herceptin 2-Year Arm
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.08
          value
          49.2
        2. group Id
          BG001
          spread
          10.06
          value
          49.0
        3. group Id
          BG002
          spread
          10.09
          value
          49.2
        4. group Id
          BG003
          spread
          10.08
          value
          49.1
    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
          1697
        2. group Id
          BG001
          value
          1702
        3. group Id
          BG002
          value
          1700
        4. group Id
          BG003
          value
          5099
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS) Population: All enrolled/randomized participants who had an available signed Informed Consent Form.

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

Preserved source evidence · Not medical advice