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NCT00335738 · BASELINE

Baseline characteristics

Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma · Source last updated 2021-02-18

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
      108
    2. group Id
      BG001
      value
      223
    3. group Id
      BG002
      value
      331
    units
    Participants
groups
  1. description
    Patients receive liposomal vincristine sulfate IV aged based dosage (Pts \< 36 mos: 0.05 mg/kg, Pts \> 36 mos: 1.5 mg/m2, max dose 2 MG) given IV or infusion on day 1, carboplatin aged based dosage (Pts \< 36 mos: 18.6 mg/kg Pts \> 36 mos: 560 mg/m2) IV on day 1, and Etoposide aged based dosage (Pts \< 36 mos: 5 mg/kg, Pts \> 36 mos: 150 mg/m2) IV on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. liposomal vincristine sulfate: Given IV carboplatin: Given IV etoposide: Given IV
    id
    BG000
    title
    Group 1 (High Risk)
  2. description
    Patients undergo observation periodically for at least 5 years.
    id
    BG001
    title
    Group 2 (Not High Risk)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          6
          value
          2
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6
          value
          1
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          6
          value
          2
    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
          52
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          172
        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
          24
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          56
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          263
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          12
        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
          37
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          100
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          25
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          151
        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
          18
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          52
        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
          65
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          209
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
      title
      New Zealand
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          87
      title
      India
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Mexico
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
      title
      Australia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Bangladesh
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      108
    2. group Id
      BG001
      value
      223
    3. group Id
      BG002
      value
      331
    units
    Participants
groups
  1. description
    Patients receive liposomal vincristine sulfate IV aged based dosage (Pts \< 36 mos: 0.05 mg/kg, Pts \> 36 mos: 1.5 mg/m2, max dose 2 MG) given IV or infusion on day 1, carboplatin aged based dosage (Pts \< 36 mos: 18.6 mg/kg Pts \> 36 mos: 560 mg/m2) IV on day 1, and Etoposide aged based dosage (Pts \< 36 mos: 5 mg/kg, Pts \> 36 mos: 150 mg/m2) IV on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. liposomal vincristine sulfate: Given IV carboplatin: Given IV etoposide: Given IV
    id
    BG000
    title
    Group 1 (High Risk)
  2. description
    Patients undergo observation periodically for at least 5 years.
    id
    BG001
    title
    Group 2 (Not High Risk)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          6
          value
          2
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6
          value
          1
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          6
          value
          2
    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
          52
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          172
        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
          24
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          56
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          181
        3. group Id
          BG002
          value
          263
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          12
        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
          37
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          100
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          25
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          151
        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
          18
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          52
        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
          65
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          209
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
      title
      New Zealand
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          87
      title
      India
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Mexico
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
      title
      Canada
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
      title
      Australia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      Bangladesh
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice