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NCT02757326 · BASELINE

Baseline characteristics

ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma · Source last updated 2021-06-18

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
      3
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      13
    units
    Participants
groups
  1. description
    For Phase 1b, ABC294640 was dosed at 250 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
    id
    BG000
    title
    Phase 1b - 250 mg BID
  2. description
    For Phase 1b, ABC294640 was dosed at 500 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment
    id
    BG001
    title
    Phase 1b - 500 mg BID
  3. description
    For Phase 1b, ABC294640 was dosed at 750 mg BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment
    id
    BG002
    title
    Phase 1b - 750 mg BID
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.58
          value
          70.0
        2. group Id
          BG001
          spread
          13.94
          value
          75.8
        3. group Id
          BG002
          spread
          6.94
          value
          63.8
        4. group Id
          BG003
          spread
          10.05
          value
          68.9
    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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        White
      6. 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
        title
        More than one race
      7. 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
        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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          13
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        ECOG 2
    description
    Lower ECOG grades correlate with a better clinical status: Grade 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 2. -Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \>50% of waking hours 3. -Capable of only limited self-care, confined to a bed or chair \>50% of waking hours 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. \- Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline ECOG (Eastern Cooperative Oncology Group)Status
    unit Of Measure
    Participants
population Description
Patients with Refractory or Relapsed Multiple Myeloma Who have Previously Been Treated with Proteasome Inhibitors and Immunomodulatory Agents were treated with three doses of ABC294640.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      13
    units
    Participants
groups
  1. description
    For Phase 1b, ABC294640 was dosed at 250 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment.
    id
    BG000
    title
    Phase 1b - 250 mg BID
  2. description
    For Phase 1b, ABC294640 was dosed at 500 BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment
    id
    BG001
    title
    Phase 1b - 500 mg BID
  3. description
    For Phase 1b, ABC294640 was dosed at 750 mg BID given continuously. The dose was given under fasting conditions (at least 1 hour before or 2 hours after eating). One cycle is 28 days of treatment
    id
    BG002
    title
    Phase 1b - 750 mg BID
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.58
          value
          70.0
        2. group Id
          BG001
          spread
          13.94
          value
          75.8
        3. group Id
          BG002
          spread
          6.94
          value
          63.8
        4. group Id
          BG003
          spread
          10.05
          value
          68.9
    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
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        title
        White
      6. 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
        title
        More than one race
      7. 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
        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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          13
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        ECOG 2
    description
    Lower ECOG grades correlate with a better clinical status: Grade 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 2. -Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \>50% of waking hours 3. -Capable of only limited self-care, confined to a bed or chair \>50% of waking hours 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. \- Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline ECOG (Eastern Cooperative Oncology Group)Status
    unit Of Measure
    Participants
population Description
Patients with Refractory or Relapsed Multiple Myeloma Who have Previously Been Treated with Proteasome Inhibitors and Immunomodulatory Agents were treated with three doses of ABC294640.

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Preserved source evidence · Not medical advice