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NCT02793544 · BASELINE

Baseline characteristics

HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide · Source last updated 2025-08-06

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
      40
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      80
    units
    Participants
groups
  1. description
    Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
    id
    BG000
    title
    Myeloablative Conditioning (MAC)
  2. description
    Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
    id
    BG001
    title
    Reduced Intensity Conditioning (RIC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          66
          value
          48.5
        2. group Id
          BG001
          lower Limit
          23
          upper Limit
          70
          value
          59.5
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          70
          value
          51.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          42
        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
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        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
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          60
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          80
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        70
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        80
      3. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          38
        title
        90
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        100
    description
    Performance score (Karnofsky if ≥ 16 years, Lansky score if \< 16 years) of participants at baseline. The range is 0 to 100 with 100 being the best.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky/Lansky performance score
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          43
        title
        3+
    description
    Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) is a tool to assess the risk of non-relapse (NRM) mortality and survival. Scores are divided into 3 groups according to risk: low risk (0), intermediate risk (1-2), and high risk (≥ 3). A higher score indicates higher risk of NRM and overall mortality.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HCT Comorbidity Index score
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          60
        title
        Acute leukemia
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        MDS
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        CLL
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          15
        title
        Lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Disease
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          55
        title
        CR1
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        title
        CR2+
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        CR
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Progression/Relapse
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        title
        PIF
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        HI
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status pre-HCT
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          50
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        High
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Very high
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        N/A
    description
    Disease risk index is categorized based on disease, stage, cytogenetics for AML, ALL, CML, CLL, MDS, MPN, HL, NHL and PCD.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Refined disease risk index
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          34
        title
        Negative
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
        title
        Positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    CMV serostatus
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        title
        TBI and Cy
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          40
        title
        TBI, CY, and Flu
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Bu and Cy
      4. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          31
        title
        Bu and Flu
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Conditioning Regimen
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      80
    units
    Participants
groups
  1. description
    Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
    id
    BG000
    title
    Myeloablative Conditioning (MAC)
  2. description
    Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
    id
    BG001
    title
    Reduced Intensity Conditioning (RIC)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          18
          upper Limit
          66
          value
          48.5
        2. group Id
          BG001
          lower Limit
          23
          upper Limit
          70
          value
          59.5
        3. group Id
          BG002
          lower Limit
          18
          upper Limit
          70
          value
          51.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          42
        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
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        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
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          60
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          80
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        70
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        title
        80
      3. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          38
        title
        90
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        100
    description
    Performance score (Karnofsky if ≥ 16 years, Lansky score if \< 16 years) of participants at baseline. The range is 0 to 100 with 100 being the best.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Karnofsky/Lansky performance score
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        title
        2
      4. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          43
        title
        3+
    description
    Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) is a tool to assess the risk of non-relapse (NRM) mortality and survival. Scores are divided into 3 groups according to risk: low risk (0), intermediate risk (1-2), and high risk (≥ 3). A higher score indicates higher risk of NRM and overall mortality.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HCT Comorbidity Index score
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          60
        title
        Acute leukemia
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        MDS
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        CLL
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          15
        title
        Lymphoma
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Disease
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          55
        title
        CR1
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        title
        CR2+
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        CR
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Progression/Relapse
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
        title
        PIF
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        HI
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status pre-HCT
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          50
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        High
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Very high
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        N/A
    description
    Disease risk index is categorized based on disease, stage, cytogenetics for AML, ALL, CML, CLL, MDS, MPN, HL, NHL and PCD.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Refined disease risk index
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          34
        title
        Negative
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          46
        title
        Positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    CMV serostatus
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        title
        TBI and Cy
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          40
        title
        TBI, CY, and Flu
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Bu and Cy
      4. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          31
        title
        Bu and Flu
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Conditioning Regimen
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice