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NCT01432600 · BASELINE

Baseline characteristics

Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide · Source last updated 2017-05-23

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
      10
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      34
    4. group Id
      BG003
      value
      80
    units
    Participants
groups
  1. description
    Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
    id
    BG000
    title
    A: Dose Escalation of Cyclophosphamide
  2. description
    Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.
    id
    BG001
    title
    B: Pomalidomide and Dexamethasone
  3. description
    Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
    id
    BG002
    title
    C: Pomalidomide, Dexamethasone, Cyclophosphamide
  4. description
    Total of all reporting groups
    id
    BG003
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          39
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          41
        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
          lower Limit
          44
          upper Limit
          73
          value
          69
        2. group Id
          BG001
          lower Limit
          50
          upper Limit
          78
          value
          64
        3. group Id
          BG002
          lower Limit
          47
          upper Limit
          80
          value
          62
        4. group Id
          BG003
          lower Limit
          44
          upper Limit
          80
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          32
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          48
        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
          10
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          80
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All participants. Arm D (a part of Arm B) started in July 2012 when, per protocol guidelines, 17 participants from Arm B elected to crossover to Arm D. Some measures may include arm D, making the total of participants evaluated higher.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      34
    4. group Id
      BG003
      value
      80
    units
    Participants
groups
  1. description
    Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
    id
    BG000
    title
    A: Dose Escalation of Cyclophosphamide
  2. description
    Phase II: Pomalidomide and high dose dexamethasone. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician. Arm D participants may be referenced separately in some Outcome Measures.
    id
    BG001
    title
    B: Pomalidomide and Dexamethasone
  3. description
    Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
    id
    BG002
    title
    C: Pomalidomide, Dexamethasone, Cyclophosphamide
  4. description
    Total of all reporting groups
    id
    BG003
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          39
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          41
        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
          lower Limit
          44
          upper Limit
          73
          value
          69
        2. group Id
          BG001
          lower Limit
          50
          upper Limit
          78
          value
          64
        3. group Id
          BG002
          lower Limit
          47
          upper Limit
          80
          value
          62
        4. group Id
          BG003
          lower Limit
          44
          upper Limit
          80
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          32
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          48
        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
          10
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          80
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
All participants. Arm D (a part of Arm B) started in July 2012 when, per protocol guidelines, 17 participants from Arm B elected to crossover to Arm D. Some measures may include arm D, making the total of participants evaluated higher.

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

Preserved source evidence · Not medical advice