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NCT01012297 · BASELINE

Baseline characteristics

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma · Source last updated 2026-06-24

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
      54
    2. group Id
      BG001
      value
      53
    3. group Id
      BG002
      value
      107
    units
    Participants
groups
  1. description
    Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
    id
    BG000
    title
    Arm I Gem+Doce+Placebo
  2. description
    Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
    id
    BG001
    title
    Arm II Gem+Doce+Bev
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.1
          value
          57.5
        2. group Id
          BG001
          spread
          8.7
          value
          54.0
        3. group Id
          BG002
          spread
          8.6
          value
          55.7
    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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        20-29 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        30-39 years
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        40-49 years
      4. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          49
        title
        50-59 years
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          31
        title
        60-69 years
      title
      Age Groups
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          107
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          91
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        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
          1
        3. group Id
          BG002
          value
          1
        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
          12
        3. group Id
          BG002
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          82
        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
          3
        3. group Id
          BG002
          value
          4
        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
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          85
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior whole pelvic radiation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          79
      title
      0: Asymptomatic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          26
      title
      1: Symptomatic, fully ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      2: Symptomatic, in bed < 50% of time
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          31
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          52
      title
      4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      unknown
    description
    FIGO Stage describes disease burden at time of surgery. Stage 1 indicates the cancer has not spread beyond the uterus. Stage 4 indicates cancer metastasis in distant organs.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FIGO Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          104
        title
        Leiomyosarcoma
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Sarcoma, Unsp.
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Carcinsarcoma
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cell Type
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      54
    2. group Id
      BG001
      value
      53
    3. group Id
      BG002
      value
      107
    units
    Participants
groups
  1. description
    Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10. Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC Placebo: Given IV
    id
    BG000
    title
    Arm I Gem+Doce+Placebo
  2. description
    Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10. Bevacizumab: Given IV Docetaxel: Given IV Filgrastim: Given SC Gemcitabine Hydrochloride: Given IV Pegfilgrastim: Given SC
    id
    BG001
    title
    Arm II Gem+Doce+Bev
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.1
          value
          57.5
        2. group Id
          BG001
          spread
          8.7
          value
          54.0
        3. group Id
          BG002
          spread
          8.6
          value
          55.7
    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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        20-29 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        30-39 years
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        40-49 years
      4. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          49
        title
        50-59 years
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          31
        title
        60-69 years
      title
      Age Groups
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          107
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          91
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          9
        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
          1
        3. group Id
          BG002
          value
          1
        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
          12
        3. group Id
          BG002
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          82
        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
          3
        3. group Id
          BG002
          value
          4
        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
          11
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          85
      title
      No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior whole pelvic radiation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          79
      title
      0: Asymptomatic
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          26
      title
      1: Symptomatic, fully ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      2: Symptomatic, in bed < 50% of time
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          31
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          52
      title
      4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      unknown
    description
    FIGO Stage describes disease burden at time of surgery. Stage 1 indicates the cancer has not spread beyond the uterus. Stage 4 indicates cancer metastasis in distant organs.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FIGO Stage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          104
        title
        Leiomyosarcoma
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Sarcoma, Unsp.
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Carcinsarcoma
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cell Type
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice