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NCT00392990 · BASELINE

Baseline characteristics

Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma · Source last updated 2019-10-15

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
      20
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      25
    units
    Participants
groups
  1. description
    Patients are stratified between high risk and low risk disease status. High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated. Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
    id
    BG000
    title
    High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles
  2. description
    Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses) 4 doses)
    id
    BG001
    title
    Low Risk - Treatment With 3 Cycles of R-CODOX-M
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          21
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          22
        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
          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
          0
        3. group Id
          BG002
          value
          0
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          22
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          25
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          21
        title
        Negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Immunodeficiency Virus (HIV) Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Within Normal Range
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          17
        title
        Elevated
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lactate dehydrogenase (LDH) Level
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        title
        2
    description
    Eastern Cooperative Oncology Group Performance Status (ECOG PS) determines the ability of patients being able to tolerate therapies in serious illness. Scale is as follows: 0 = Asymptomatic, normal activity 1. = Symptomatic but completely ambulatory 2. = Symptomatic, less than 50% of time in bed but not bedbound 3. = In bed more than 50% of the time 4. = 100% bedridden 5. = death
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status (ECOG PS)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          17
        title
        No
    description
    Bulky disease is defined as disease in which there is a tumor mass more than 10 cm in its greatest diameter
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bulky disease
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          15
        title
        Stage IV
    description
    Classification for Hodgkin Lymphoma ranging from I-IV with IV being worse disease with liver or bone marrow, lungs or cerebrospinal fluid involvement.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ann Arbor Stage
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      20
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      25
    units
    Participants
groups
  1. description
    Patients are stratified between high risk and low risk disease status. High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated. Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
    id
    BG000
    title
    High Risk - Treated With Alternating R-CODOX-M/R-IVAC Cycles
  2. description
    Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses) 4 doses)
    id
    BG001
    title
    Low Risk - Treatment With 3 Cycles of R-CODOX-M
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          21
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          22
        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
          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
          0
        3. group Id
          BG002
          value
          0
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          22
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          25
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          21
        title
        Negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Immunodeficiency Virus (HIV) Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Within Normal Range
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          17
        title
        Elevated
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Lactate dehydrogenase (LDH) Level
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        title
        2
    description
    Eastern Cooperative Oncology Group Performance Status (ECOG PS) determines the ability of patients being able to tolerate therapies in serious illness. Scale is as follows: 0 = Asymptomatic, normal activity 1. = Symptomatic but completely ambulatory 2. = Symptomatic, less than 50% of time in bed but not bedbound 3. = In bed more than 50% of the time 4. = 100% bedridden 5. = death
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status (ECOG PS)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          17
        title
        No
    description
    Bulky disease is defined as disease in which there is a tumor mass more than 10 cm in its greatest diameter
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bulky disease
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          15
        title
        Stage IV
    description
    Classification for Hodgkin Lymphoma ranging from I-IV with IV being worse disease with liver or bone marrow, lungs or cerebrospinal fluid involvement.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ann Arbor Stage
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice