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NCT01042522 · BASELINE

Baseline characteristics

Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors · Source last updated 2022-01-25

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
      31
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      63
    units
    Participants
groups
  1. description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
    id
    BG000
    title
    Arm I (Paclitaxel, Carboplatin)
  2. description
    Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    BG001
    title
    Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.51
          value
          50.71
        2. group Id
          BG001
          spread
          13.86
          value
          44.05
        3. group Id
          BG002
          spread
          13.53
          value
          47.33
    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
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        title
        20 - 29 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        30 - 39 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        title
        40 - 49 years
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        title
        50 - 59 years
      5. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        >= 60 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          63
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          50
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. 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
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          48
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          49
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        2
    description
    For Performance Status, the GOG- score was used: 0 = normal activity, asymptomatic 1. = symptomatic, fully ambulatory 2. = symptomatic, in bed \< 50% of time 3. = symptomatic, in bed \> 50% of time 4. = 100% bedridden
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        Measurable Disease
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          40
        title
        No Measurable Disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Lipid Cell Tumor
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
        title
        Granulosa Cell Tumor
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Sex Cord Stromal Tumor, Unclassified
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Sertoli-leydig Cell Tumor
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cell Type
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    2. group Id
      BG001
      value
      32
    3. group Id
      BG002
      value
      63
    units
    Participants
groups
  1. description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
    id
    BG000
    title
    Arm I (Paclitaxel, Carboplatin)
  2. description
    Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    BG001
    title
    Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.51
          value
          50.71
        2. group Id
          BG001
          spread
          13.86
          value
          44.05
        3. group Id
          BG002
          spread
          13.53
          value
          47.33
    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
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        title
        20 - 29 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        title
        30 - 39 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        title
        40 - 49 years
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        title
        50 - 59 years
      5. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        >= 60 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          63
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          50
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. 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
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          48
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          49
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        2
    description
    For Performance Status, the GOG- score was used: 0 = normal activity, asymptomatic 1. = symptomatic, fully ambulatory 2. = symptomatic, in bed \< 50% of time 3. = symptomatic, in bed \> 50% of time 4. = 100% bedridden
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        Measurable Disease
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          40
        title
        No Measurable Disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Lipid Cell Tumor
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          55
        title
        Granulosa Cell Tumor
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Sex Cord Stromal Tumor, Unclassified
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Sertoli-leydig Cell Tumor
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cell Type
    unit Of Measure
    Participants

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