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NCT00833833 · BASELINE

Baseline characteristics

MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-04-27

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
      14
    4. group Id
      BG003
      value
      10
    5. group Id
      BG004
      value
      113
    6. group Id
      BG005
      value
      108
    7. group Id
      BG006
      value
      259
    units
    Participants
groups
  1. description
    Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG000
    title
    Phase 1: 2 mg Pomalidomide
  2. description
    Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG001
    title
    Phase 1: 3 mg Pomalidomide
  3. description
    Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG002
    title
    Phase 1: 4 mg Pomalidomide
  4. description
    Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG003
    title
    Phase 1: 5 mg Pomalidomide
  5. description
    Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    BG004
    title
    Phase 2: Pomalidomide + Dexamethasone
  6. description
    4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
    id
    BG005
    title
    Phase 2: Pomalidomide
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.83
          value
          64.7
        2. group Id
          BG001
          spread
          6.63
          value
          70.4
        3. group Id
          BG002
          spread
          8.98
          value
          67.5
        4. group Id
          BG003
          spread
          14.06
          value
          61.3
        5. group Id
          BG004
          spread
          9.24
          value
          64.4
        6. group Id
          BG005
          spread
          10.35
          value
          62.9
        7. group Id
          BG006
          spread
          9.86
          value
          64.1
    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
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          99
        6. group Id
          BG005
          value
          95
        7. group Id
          BG006
          value
          226
      title
      <=75 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          33
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          51
        6. group Id
          BG005
          value
          51
        7. group Id
          BG006
          value
          122
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          62
        6. group Id
          BG005
          value
          57
        7. group Id
          BG006
          value
          137
        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
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
      title
      Asian
    2. 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
          0
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          34
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          92
        6. group Id
          BG005
          value
          86
        7. group Id
          BG006
          value
          213
      title
      White
    4. 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
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          44
        7. group Id
          BG006
          value
          110
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          56
        6. group Id
          BG005
          value
          59
        7. group Id
          BG006
          value
          140
      title
      Abnormal, not clinically significant
    3. 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
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
      title
      Abnormal, clinically significant
    4. 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
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
      title
      Missing
    param Type
    NUMBER
    title
    Baseline Electrocardiogram Findings
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          32
        6. group Id
          BG005
          value
          24
        7. group Id
          BG006
          value
          62
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          68
        6. group Id
          BG005
          value
          71
        7. group Id
          BG006
          value
          163
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          32
      title
      2
    4. 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
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
      title
      3
    description
    The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          23
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          29
        7. group Id
          BG006
          value
          64
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          76
        6. group Id
          BG005
          value
          71
        7. group Id
          BG006
          value
          172
      title
      Stage III
    description
    Multiple myeloma has three stages, which are known as stage I, stage II and stage III. Staging in myeloma is done on the basis of the value of serum albumin and beta-2 microglobulin level. Stage I has the best prognosis and stage III the worst prognosis.
    param Type
    NUMBER
    title
    Baseline Multiple Myeloma Stage
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          113
        6. group Id
          BG005
          value
          108
        7. group Id
          BG006
          value
          259
      title
      Yes
    2. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
      title
      No
    param Type
    NUMBER
    title
    Prior Anti-Myeloma Therapies
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          76
        6. group Id
          BG005
          value
          72
        7. group Id
          BG006
          value
          178
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          37
        6. group Id
          BG005
          value
          36
        7. group Id
          BG006
          value
          81
      title
      No
    param Type
    NUMBER
    title
    Prior Thalidomide Exposure
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          84
        6. group Id
          BG005
          value
          82
        7. group Id
          BG006
          value
          191
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          68
      title
      No
    param Type
    NUMBER
    title
    Prior Stem Cell Transplant
    unit Of Measure
    participants
population Description
Intent to treat population from both phases
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      10
    5. group Id
      BG004
      value
      113
    6. group Id
      BG005
      value
      108
    7. group Id
      BG006
      value
      259
    units
    Participants
groups
  1. description
    Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG000
    title
    Phase 1: 2 mg Pomalidomide
  2. description
    Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG001
    title
    Phase 1: 3 mg Pomalidomide
  3. description
    Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG002
    title
    Phase 1: 4 mg Pomalidomide
  4. description
    Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
    id
    BG003
    title
    Phase 1: 5 mg Pomalidomide
  5. description
    Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    BG004
    title
    Phase 2: Pomalidomide + Dexamethasone
  6. description
    4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
    id
    BG005
    title
    Phase 2: Pomalidomide
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.83
          value
          64.7
        2. group Id
          BG001
          spread
          6.63
          value
          70.4
        3. group Id
          BG002
          spread
          8.98
          value
          67.5
        4. group Id
          BG003
          spread
          14.06
          value
          61.3
        5. group Id
          BG004
          spread
          9.24
          value
          64.4
        6. group Id
          BG005
          spread
          10.35
          value
          62.9
        7. group Id
          BG006
          spread
          9.86
          value
          64.1
    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
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          99
        6. group Id
          BG005
          value
          95
        7. group Id
          BG006
          value
          226
      title
      <=75 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          13
        7. group Id
          BG006
          value
          33
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          51
        6. group Id
          BG005
          value
          51
        7. group Id
          BG006
          value
          122
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          62
        6. group Id
          BG005
          value
          57
        7. group Id
          BG006
          value
          137
        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
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
      title
      Asian
    2. 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
          0
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          34
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          92
        6. group Id
          BG005
          value
          86
        7. group Id
          BG006
          value
          213
      title
      White
    4. 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
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          44
        7. group Id
          BG006
          value
          110
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          56
        6. group Id
          BG005
          value
          59
        7. group Id
          BG006
          value
          140
      title
      Abnormal, not clinically significant
    3. 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
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
      title
      Abnormal, clinically significant
    4. 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
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
      title
      Missing
    param Type
    NUMBER
    title
    Baseline Electrocardiogram Findings
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          32
        6. group Id
          BG005
          value
          24
        7. group Id
          BG006
          value
          62
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          68
        6. group Id
          BG005
          value
          71
        7. group Id
          BG006
          value
          163
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          32
      title
      2
    4. 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
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
      title
      3
    description
    The ECOG scale is as follows: Grade 0: Fully active, able to carry on all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          23
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          29
        7. group Id
          BG006
          value
          64
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          76
        6. group Id
          BG005
          value
          71
        7. group Id
          BG006
          value
          172
      title
      Stage III
    description
    Multiple myeloma has three stages, which are known as stage I, stage II and stage III. Staging in myeloma is done on the basis of the value of serum albumin and beta-2 microglobulin level. Stage I has the best prognosis and stage III the worst prognosis.
    param Type
    NUMBER
    title
    Baseline Multiple Myeloma Stage
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          113
        6. group Id
          BG005
          value
          108
        7. group Id
          BG006
          value
          259
      title
      Yes
    2. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
      title
      No
    param Type
    NUMBER
    title
    Prior Anti-Myeloma Therapies
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          76
        6. group Id
          BG005
          value
          72
        7. group Id
          BG006
          value
          178
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          37
        6. group Id
          BG005
          value
          36
        7. group Id
          BG006
          value
          81
      title
      No
    param Type
    NUMBER
    title
    Prior Thalidomide Exposure
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          84
        6. group Id
          BG005
          value
          82
        7. group Id
          BG006
          value
          191
      title
      Yes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          29
        6. group Id
          BG005
          value
          26
        7. group Id
          BG006
          value
          68
      title
      No
    param Type
    NUMBER
    title
    Prior Stem Cell Transplant
    unit Of Measure
    participants
population Description
Intent to treat population from both phases

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Preserved source evidence · Not medical advice