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NCT00697346 · BASELINE

Baseline characteristics

Study of MLN8237 in Participants With Advanced Hematological Malignancies · Source last updated 2019-05-31

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
      28
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      58
    units
    Participants
groups
  1. description
    Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
    id
    BG000
    title
    Part 1: PIC Dose Escalation
  2. description
    Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
    id
    BG001
    title
    Part 1: ECT Dose Escalation
  3. description
    Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
    id
    BG002
    title
    Part 2: PTCL
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.91
          value
          61.4
        2. group Id
          BG001
          spread
          14.22
          value
          59.5
        3. group Id
          BG002
          spread
          24.04
          value
          63.0
        4. group Id
          BG003
          spread
          12.03
          value
          60.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    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
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          27
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          41
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      Asian
    4. categories
      1. 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
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.25
          value
          165.9
        2. group Id
          BG001
          spread
          10.95
          value
          164.6
        3. group Id
          BG002
          spread
          6.43
          value
          160.6
        4. group Id
          BG003
          spread
          10.89
          value
          165.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          56
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here number analyzed is the number of participants who were evaluated for height at baseline.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.031
          value
          81.40
        2. group Id
          BG001
          spread
          19.747
          value
          77.62
        3. group Id
          BG002
          spread
          43.911
          value
          97.65
        4. group Id
          BG003
          spread
          20.573
          value
          80.13
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.282
          value
          1.93
        2. group Id
          BG001
          spread
          0.289
          value
          1.88
        3. group Id
          BG002
          spread
          0.434
          value
          2.05
        4. group Id
          BG003
          spread
          0.286
          value
          1.91
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          56
        units
        Participants
    description
    Body Surface Area =square root \[height (cm) \* weight (kg) / 3600\].
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here number analyzed is the number of participants who were evaluated for body surface area at baseline.
    title
    Body Surface Area
    unit Of Measure
    m^2
population Description
Safety population is defined as all participants who received any amount of alisertib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      28
    2. group Id
      BG001
      value
      28
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      58
    units
    Participants
groups
  1. description
    Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
    id
    BG000
    title
    Part 1: PIC Dose Escalation
  2. description
    Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
    id
    BG001
    title
    Part 1: ECT Dose Escalation
  3. description
    Participants with peripheral T-cell lymphoma (PTCL) received alisertib 50 mg ECT, orally, BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 2 cycles).
    id
    BG002
    title
    Part 2: PTCL
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.91
          value
          61.4
        2. group Id
          BG001
          spread
          14.22
          value
          59.5
        3. group Id
          BG002
          spread
          24.04
          value
          63.0
        4. group Id
          BG003
          spread
          12.03
          value
          60.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    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
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          27
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          16
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          41
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      Asian
    4. categories
      1. 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
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      Not Reported
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.25
          value
          165.9
        2. group Id
          BG001
          spread
          10.95
          value
          164.6
        3. group Id
          BG002
          spread
          6.43
          value
          160.6
        4. group Id
          BG003
          spread
          10.89
          value
          165.1
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          56
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here number analyzed is the number of participants who were evaluated for height at baseline.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.031
          value
          81.40
        2. group Id
          BG001
          spread
          19.747
          value
          77.62
        3. group Id
          BG002
          spread
          43.911
          value
          97.65
        4. group Id
          BG003
          spread
          20.573
          value
          80.13
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          58
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.282
          value
          1.93
        2. group Id
          BG001
          spread
          0.289
          value
          1.88
        3. group Id
          BG002
          spread
          0.434
          value
          2.05
        4. group Id
          BG003
          spread
          0.286
          value
          1.91
      denoms
      1. counts
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          56
        units
        Participants
    description
    Body Surface Area =square root \[height (cm) \* weight (kg) / 3600\].
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here number analyzed is the number of participants who were evaluated for body surface area at baseline.
    title
    Body Surface Area
    unit Of Measure
    m^2
population Description
Safety population is defined as all participants who received any amount of alisertib.

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