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NCT04145531 · BASELINE

Baseline characteristics

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) · Source last updated 2023-11-18

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
      33
    2. group Id
      BG001
      value
      83
    3. group Id
      BG002
      value
      51
    4. group Id
      BG003
      value
      61
    5. group Id
      BG004
      value
      228
    units
    Participants
groups
  1. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
    id
    BG000
    title
    Part A: JZP-458 IM 25 mg/m^2 (MWF)
  2. description
    Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    BG001
    title
    Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
  3. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    BG002
    title
    Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
  4. description
    Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    BG003
    title
    Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          54
        5. group Id
          BG004
          value
          204
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          24
        title
        Between 18 and 65 years
      3. 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
        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
          7.11
          value
          11.5
        2. group Id
          BG001
          spread
          5.08
          value
          9.0
        3. group Id
          BG002
          spread
          5.41
          value
          11.3
        4. group Id
          BG003
          spread
          6.30
          value
          10.4
        5. group Id
          BG004
          spread
          5.86
          value
          10.3
    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
          16
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          89
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          139
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          24
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          158
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          29
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Demographic and baseline characteristics were assessed in the Safety Analysis Set.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      33
    2. group Id
      BG001
      value
      83
    3. group Id
      BG002
      value
      51
    4. group Id
      BG003
      value
      61
    5. group Id
      BG004
      value
      228
    units
    Participants
groups
  1. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
    id
    BG000
    title
    Part A: JZP-458 IM 25 mg/m^2 (MWF)
  2. description
    Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    BG001
    title
    Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
  3. description
    Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    BG002
    title
    Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
  4. description
    Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
    id
    BG003
    title
    Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          46
        4. group Id
          BG003
          value
          54
        5. group Id
          BG004
          value
          204
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          24
        title
        Between 18 and 65 years
      3. 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
        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
          7.11
          value
          11.5
        2. group Id
          BG001
          spread
          5.08
          value
          9.0
        3. group Id
          BG002
          spread
          5.41
          value
          11.3
        4. group Id
          BG003
          spread
          6.30
          value
          10.4
        5. group Id
          BG004
          spread
          5.86
          value
          10.3
    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
          16
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          89
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          139
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          24
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          43
        5. group Id
          BG004
          value
          158
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          29
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Demographic and baseline characteristics were assessed in the Safety Analysis Set.

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Preserved source evidence · Not medical advice