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NCT00481871 · BASELINE

Baseline characteristics

Study of Pralatrexate & Gemcitabine With B12 & Folic Acid to Treat Relapsed/Refractory Lymphoproliferative Malignancies · Source last updated 2020-01-07

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
      7
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      38
    5. group Id
      BG004
      value
      34
    6. group Id
      BG005
      value
      107
    units
    Participants
groups
  1. description
    Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
    id
    BG000
    title
    Phase 1 - Group A
  2. description
    Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
    id
    BG001
    title
    Phase 1 - Group B
  3. description
    Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
    id
    BG002
    title
    Phase 1 - Group C
  4. description
    Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
    id
    BG003
    title
    Phase 2 - Group B
  5. description
    Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
    id
    BG004
    title
    Phase 2 - Group C
  6. description
    Total of all reporting groups
    id
    BG005
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          71
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          36
        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
          spread
          15
          value
          67.6
        2. group Id
          BG001
          spread
          18
          value
          52.4
        3. group Id
          BG002
          spread
          17
          value
          57.4
        4. group Id
          BG003
          spread
          16
          value
          57.9
        5. group Id
          BG004
          spread
          15
          value
          53.2
        6. group Id
          BG005
          spread
          16.1
          value
          56.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          42
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          65
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          38
        5. group Id
          BG004
          value
          34
        6. group Id
          BG005
          value
          107
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      38
    5. group Id
      BG004
      value
      34
    6. group Id
      BG005
      value
      107
    units
    Participants
groups
  1. description
    Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
    id
    BG000
    title
    Phase 1 - Group A
  2. description
    Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
    id
    BG001
    title
    Phase 1 - Group B
  3. description
    Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
    id
    BG002
    title
    Phase 1 - Group C
  4. description
    Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
    id
    BG003
    title
    Phase 2 - Group B
  5. description
    Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
    id
    BG004
    title
    Phase 2 - Group C
  6. description
    Total of all reporting groups
    id
    BG005
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          71
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          36
        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
          spread
          15
          value
          67.6
        2. group Id
          BG001
          spread
          18
          value
          52.4
        3. group Id
          BG002
          spread
          17
          value
          57.4
        4. group Id
          BG003
          spread
          16
          value
          57.9
        5. group Id
          BG004
          spread
          15
          value
          53.2
        6. group Id
          BG005
          spread
          16.1
          value
          56.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          42
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          65
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          38
        5. group Id
          BG004
          value
          34
        6. group Id
          BG005
          value
          107
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice