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NCT00074152 · BASELINE

Baseline characteristics

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer · Source last updated 2017-06-16

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
      77
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      162
    units
    Participants
groups
  1. description
    Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
    id
    BG000
    title
    Arm I
  2. description
    Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
    id
    BG001
    title
    Arm II
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          131
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          31
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          162
        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
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          42
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          33
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
      title
      Canada
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Peru
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Australia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      South Africa
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Netherlands
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
      title
      Switzerland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          101
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          61
      title
      No
    param Type
    NUMBER
    title
    Prior chemotherapy
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          64
      title
      Mastectomy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          98
      title
      Breast conserving
    param Type
    NUMBER
    title
    Surgery for primary tumor
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          104
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          58
      title
      Negative
    param Type
    NUMBER
    title
    Estrogen receptor (ER) status of the isolated local or regional recurrence
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          79
      title
      positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          79
      title
      negative
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      not available
    param Type
    NUMBER
    title
    Progesterone receptor (PgR) status of the isolated local or regional recurrence
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          88
      title
      Breast
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          53
      title
      Mx scar/chest wall
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
      title
      Regional lymph nodes
    param Type
    NUMBER
    title
    Location of isolated loco-regional recurrence (ILRR)
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          34
      title
      pre
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          128
      title
      post
    param Type
    NUMBER
    title
    Menopausal Status at isolated loco-regional recurrence (ILRR)
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.9
          upper Limit
          11.3
          value
          6.2
        2. group Id
          BG001
          lower Limit
          2.9
          upper Limit
          9.5
          value
          5.0
        3. group Id
          BG002
          lower Limit
          2.9
          upper Limit
          11.3
          value
          5.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from primary surgery to isolated loco-regional recurrence (ILRR) surgery
    unit Of Measure
    years
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          47
      title
      negative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          96
      title
      positive
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      unknown
    param Type
    NUMBER
    title
    Estrogen receptor (ER) status of primary tumor
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      77
    2. group Id
      BG001
      value
      85
    3. group Id
      BG002
      value
      162
    units
    Participants
groups
  1. description
    Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
    id
    BG000
    title
    Arm I
  2. description
    Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
    id
    BG001
    title
    Arm II
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          131
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          31
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          85
        3. group Id
          BG002
          value
          162
        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
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          42
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          33
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
      title
      Canada
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          20
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Peru
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Australia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      South Africa
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
      title
      Netherlands
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
      title
      Switzerland
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          101
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          61
      title
      No
    param Type
    NUMBER
    title
    Prior chemotherapy
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          64
      title
      Mastectomy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          98
      title
      Breast conserving
    param Type
    NUMBER
    title
    Surgery for primary tumor
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          104
      title
      Positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          58
      title
      Negative
    param Type
    NUMBER
    title
    Estrogen receptor (ER) status of the isolated local or regional recurrence
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          79
      title
      positive
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          79
      title
      negative
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      not available
    param Type
    NUMBER
    title
    Progesterone receptor (PgR) status of the isolated local or regional recurrence
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          88
      title
      Breast
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          53
      title
      Mx scar/chest wall
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          21
      title
      Regional lymph nodes
    param Type
    NUMBER
    title
    Location of isolated loco-regional recurrence (ILRR)
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          34
      title
      pre
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          128
      title
      post
    param Type
    NUMBER
    title
    Menopausal Status at isolated loco-regional recurrence (ILRR)
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2.9
          upper Limit
          11.3
          value
          6.2
        2. group Id
          BG001
          lower Limit
          2.9
          upper Limit
          9.5
          value
          5.0
        3. group Id
          BG002
          lower Limit
          2.9
          upper Limit
          11.3
          value
          5.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from primary surgery to isolated loco-regional recurrence (ILRR) surgery
    unit Of Measure
    years
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          47
      title
      negative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          96
      title
      positive
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      unknown
    param Type
    NUMBER
    title
    Estrogen receptor (ER) status of primary tumor
    unit Of Measure
    participants

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