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NCT01007942 · BASELINE

Baseline characteristics

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer · Source last updated 2017-04-05

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
      284
    2. group Id
      BG001
      value
      285
    3. group Id
      BG002
      value
      569
    units
    Participants
groups
  1. description
    Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
    id
    BG000
    title
    Everolimus + Vinorelbine + Trastuzumab
  2. description
    Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
    id
    BG001
    title
    Placebo + Vinorelbine + Trastuzumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.98
          value
          54.3
        2. group Id
          BG001
          spread
          11.00
          value
          53.4
        3. group Id
          BG002
          spread
          10.99
          value
          53.8
    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
          284
        2. group Id
          BG001
          value
          285
        3. group Id
          BG002
          value
          569
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) consisted of all randomized patients.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      284
    2. group Id
      BG001
      value
      285
    3. group Id
      BG002
      value
      569
    units
    Participants
groups
  1. description
    Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
    id
    BG000
    title
    Everolimus + Vinorelbine + Trastuzumab
  2. description
    Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
    id
    BG001
    title
    Placebo + Vinorelbine + Trastuzumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.98
          value
          54.3
        2. group Id
          BG001
          spread
          11.00
          value
          53.4
        3. group Id
          BG002
          spread
          10.99
          value
          53.8
    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
          284
        2. group Id
          BG001
          value
          285
        3. group Id
          BG002
          value
          569
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) consisted of all randomized patients.

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

Preserved source evidence · Not medical advice