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NCT00747123 · BASELINE

Baseline characteristics

A Safety, Tolerability and Efficacy Study of ACE-011 in Patients With Osteolytic Lesions of Multiple Myeloma · Source last updated 2024-10-03

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
      6
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      30
    units
    Participants
groups
  1. description
    Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.
    id
    BG000
    title
    Placebo
  2. description
    0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    BG001
    title
    0.1 mg/kg ACE 011
  3. description
    0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)
    id
    BG002
    title
    0.3 mg/kg ACE 011
  4. description
    0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    BG003
    title
    0.5 mg/kg ACE 011
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.92
          value
          62.0
        2. group Id
          BG001
          spread
          13.28
          value
          60.5
        3. group Id
          BG002
          spread
          7.50
          value
          63.6
        4. group Id
          BG003
          spread
          12.30
          value
          57.8
        5. group Id
          BG004
          spread
          10.42
          value
          60.9
    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
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          15
        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
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        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
          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
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          29
        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
        5. group Id
          BG004
          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
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      8
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      30
    units
    Participants
groups
  1. description
    Placebo was administered within 28 days of screening. Subsequent doses were administered every 28 days for a total of four doses.
    id
    BG000
    title
    Placebo
  2. description
    0.1 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    BG001
    title
    0.1 mg/kg ACE 011
  3. description
    0.3 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169)
    id
    BG002
    title
    0.3 mg/kg ACE 011
  4. description
    0.5 mg/kg administered via subcutaneous injection every 28 days for a total of four doses (i.e., Days 1, 29, 57, and 85), with safety follow-up visits 1 week after each dose (i.e., Days 8, 36, 64, and 92). After completion of the treatment period, participants returned to the study site monthly for follow-up assessments for an additional 3 months (i.e., Days 113, 141, and 169).
    id
    BG003
    title
    0.5 mg/kg ACE 011
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.92
          value
          62.0
        2. group Id
          BG001
          spread
          13.28
          value
          60.5
        3. group Id
          BG002
          spread
          7.50
          value
          63.6
        4. group Id
          BG003
          spread
          12.30
          value
          57.8
        5. group Id
          BG004
          spread
          10.42
          value
          60.9
    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
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          15
        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
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        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
          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
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          29
        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
        5. group Id
          BG004
          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
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice