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NCT01259856 · BASELINE

Baseline characteristics

Randomized Trial of Pegylated Interferon Alfa-2a Versus Hydroxyurea in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) · Source last updated 2019-04-30

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
      82
    2. group Id
      BG001
      value
      86
    3. group Id
      BG002
      value
      168
    units
    Participants
groups
  1. description
    The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    BG000
    title
    PEGASYS
  2. description
    Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    BG001
    title
    Hydroxyurea
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.8
          value
          56.8
        2. group Id
          BG001
          spread
          12.8
          value
          61.8
        3. group Id
          BG002
          spread
          14.0
          value
          59.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          98
        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
          3
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          146
        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
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        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
          42
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          98
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age > 60 years
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          137
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      3+
    description
    The ECOG measures level of functioning in terms of daily living abilities: 0-Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg.light house work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about \>50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair \>50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    The Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          81
      title
      Essential thrombocythemia (ET)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          87
      title
      Polycythemia Vera (PV)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Type
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          46
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Thrombosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Hemorrhage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Splenomegaly
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          41.7
          value
          2.6
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          84.2
          value
          3.0
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          84.2
          value
          2.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Disease Duration
    unit Of Measure
    months
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      82
    2. group Id
      BG001
      value
      86
    3. group Id
      BG002
      value
      168
    units
    Participants
groups
  1. description
    The subject received the PEGASYS at a dose level of 45 micrograms weekly and gradually increased to the maximum dose of 180 micrograms per week. The dose was administered by prefilled syringes and injected subcutaneously. Subjects received therapy for up to 12 months. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    BG000
    title
    PEGASYS
  2. description
    Subjects received a 500mg tablet to be taken twice daily for up to 12 months of treatment. Aspirin: Subject asked to take 81 to 100mg per day for the 12 months of the study treatment.
    id
    BG001
    title
    Hydroxyurea
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.8
          value
          56.8
        2. group Id
          BG001
          spread
          12.8
          value
          61.8
        3. group Id
          BG002
          spread
          14.0
          value
          59.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          98
        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
          3
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          146
        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
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        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
          42
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          98
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age > 60 years
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          137
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      3+
    description
    The ECOG measures level of functioning in terms of daily living abilities: 0-Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg.light house work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about \>50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair \>50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    The Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          81
      title
      Essential thrombocythemia (ET)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          87
      title
      Polycythemia Vera (PV)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Type
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          46
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Thrombosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Hemorrhage
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Splenomegaly
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          41.7
          value
          2.6
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          84.2
          value
          3.0
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          84.2
          value
          2.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Disease Duration
    unit Of Measure
    months

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Preserved source evidence · Not medical advice