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NCT01773395 · BASELINE

Baseline characteristics

GVAX vs. Placebo for MDS/AML After Allo HSCT · Source last updated 2022-07-18

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
      30
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      57
    units
    Participants
groups
  1. description
    GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
    id
    BG000
    title
    GVAX
  2. description
    Placebo Participants in the Placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          75
          value
          64
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          74
          value
          63
        3. group Id
          BG002
          lower Limit
          27
          upper Limit
          75
          value
          63
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          53
        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
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19
          upper Limit
          67
          value
          28
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          68
          value
          30
        3. group Id
          BG002
          lower Limit
          19
          upper Limit
          68
          value
          28
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Donor Age
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        ECOG 0-Fully active; no performance restrictions.
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
        title
        ECOG 1-Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        ECOG 2-Capable of all self-care but unable to carry out any work activity Up and about >50% of time
      denoms
      1. counts
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ECOG Score at baseline was not available for one participant
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
      title
      Female Donor
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          40
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
      title
      Male Donor
    param Type
    NUMBER
    title
    Donor Sex
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    NUMBER
    title
    Male Recipient With female Donor
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        title
        Acute Myeloid Leukemia
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        title
        Myelodysplastic Syndrome
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Transplanted
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        2nd Complete Remission-Leukemia returned after a remission and there are now no signs of disease
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Induction Failure-Leukemia has not gone away and not responded to 2 cycles of chemotherapy
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Relapsed- Leukemia has returned after a period of remission
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Untreated- Leukemia has never been treated
      denoms
      1. counts
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients with AML analyzed.
    title
    Acute Myeloid Leukemia Disease Status At Transplantation
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Favorable (Best Risk)
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Intermediate (Middle Risk)
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        title
        Adverse (Worst Risk)
      denoms
      1. counts
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        units
        Participants
    description
    System used to provide prognostic information in AML based on identified genetic abnormalities. Scale is from favorable to intermediate to adverse.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients with AML analyzed
    title
    AML European Leukemia Net (ELN) Risk Stratification
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Treatment Related MDS- MDS arising from cytotoxic therapy given for a prior condition
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
        title
        Non-Treatment Related MDS- Disease which has arisen with no apparent cause
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients with MDS analyzed
    title
    Myelodysplastic Syndrome Type at Transplant
    unit Of Measure
    Participants
population Description
Baseline Analysis Population only includes participants who received at least 1 GVAX or placebo vaccine
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      30
    2. group Id
      BG001
      value
      27
    3. group Id
      BG002
      value
      57
    units
    Participants
groups
  1. description
    GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
    id
    BG000
    title
    GVAX
  2. description
    Placebo Participants in the Placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          27
          upper Limit
          75
          value
          64
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          74
          value
          63
        3. group Id
          BG002
          lower Limit
          27
          upper Limit
          75
          value
          63
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. 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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          53
        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
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          19
          upper Limit
          67
          value
          28
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          68
          value
          30
        3. group Id
          BG002
          lower Limit
          19
          upper Limit
          68
          value
          28
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Donor Age
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        ECOG 0-Fully active; no performance restrictions.
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          33
        title
        ECOG 1-Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        title
        ECOG 2-Capable of all self-care but unable to carry out any work activity Up and about >50% of time
      denoms
      1. counts
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ECOG Score at baseline was not available for one participant
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
      title
      Female Donor
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          40
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
      title
      Male Donor
    param Type
    NUMBER
    title
    Donor Sex
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    NUMBER
    title
    Male Recipient With female Donor
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        title
        Acute Myeloid Leukemia
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        title
        Myelodysplastic Syndrome
      denoms
      1. counts
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          57
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Transplanted
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        2nd Complete Remission-Leukemia returned after a remission and there are now no signs of disease
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Induction Failure-Leukemia has not gone away and not responded to 2 cycles of chemotherapy
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Relapsed- Leukemia has returned after a period of remission
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Untreated- Leukemia has never been treated
      denoms
      1. counts
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients with AML analyzed.
    title
    Acute Myeloid Leukemia Disease Status At Transplantation
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Favorable (Best Risk)
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          9
        title
        Intermediate (Middle Risk)
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        title
        Adverse (Worst Risk)
      denoms
      1. counts
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        units
        Participants
    description
    System used to provide prognostic information in AML based on identified genetic abnormalities. Scale is from favorable to intermediate to adverse.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients with AML analyzed
    title
    AML European Leukemia Net (ELN) Risk Stratification
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Treatment Related MDS- MDS arising from cytotoxic therapy given for a prior condition
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
        title
        Non-Treatment Related MDS- Disease which has arisen with no apparent cause
      denoms
      1. counts
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Only patients with MDS analyzed
    title
    Myelodysplastic Syndrome Type at Transplant
    unit Of Measure
    Participants
population Description
Baseline Analysis Population only includes participants who received at least 1 GVAX or placebo vaccine

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