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NCT02633059 · BASELINE

Baseline characteristics

Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2024-09-19

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
      4
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      18
    5. group Id
      BG004
      value
      33
    units
    Participants
groups
  1. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
    id
    BG000
    title
    Phase 1: Dose Level 0
  2. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    BG001
    title
    Phase 1: Dose Level 1
  3. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
    id
    BG002
    title
    Phase 1: Dose Level 2
  4. description
    Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    BG003
    title
    Phase 2: Dose Level 1
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.60
          value
          67.3
        2. group Id
          BG001
          spread
          8.69
          value
          60.9
        3. group Id
          BG002
          spread
          12.03
          value
          63.0
        4. group Id
          BG003
          spread
          7.65
          value
          65.0
        5. group Id
          BG004
          spread
          8.19
          value
          64.2
    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
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          25
        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
          2
        5. group Id
          BG004
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          31
        title
        Not Hispanic or Latino
      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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        5. group Id
          BG004
          value
          2
        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
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          27
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          11
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          19
      title
      1
    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
          2
        5. group Id
          BG004
          value
          3
      title
      2
    description
    ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction.\> ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.\> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.\> ECOG = 0 is better. ECOG = 2 is worse.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status (PS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          28
      title
      High Risk
    2. 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
          4
        5. group Id
          BG004
          value
          5
      title
      Standard Risk
    description
    Standard Risk: All others including: Trisomies t(11;14)d t(6;14).\> High Risk: t(4;14) t(14;16) t(14;20) Del 17p 53 mutation Gain 1q RISS Stage 3 High Plasma Cell S-phasec GEP: High risk signature.\> Standard Risk is best, High Risk is worst.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mayo Clinic Stratification for Myeloma and Risk-Adapted Therapy (mSMART)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          15
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
      title
      Stage III
    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
          4
        5. group Id
          BG004
          value
          4
      title
      Unknown
    5. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Missing
    description
    Stage I: Sβ2M \< 3.5 mg/L; serum albumin ≥ 3.5 g/dL\> Stage II: Sβ2M \< 3.5 mg/L; serum albumin \< 3.5 g/dL; or β2M 3.5 to 5.5 mg/L, irrespective of serum albumin\> Stage III: Sβ2M \> 5.5 mg/L\> Stage I is best, Stage III is worst.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    What was the International Staging System myeloma stage?
    unit Of Measure
    Participants
  8. classes
    1. 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
          2
        5. group Id
          BG004
          value
          3
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          25
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
      title
      III
    description
    Stage I: Sβ2M \< 3.5 mg/l, Serum albumin ≥ 3.5 g/dl, Standard-risk chromosomal abnormalities (CA) by iFISH, Normal LDH\> Stage II: Not R-ISS stage I or III\> Stage III: Sβ2M ≥ 5.5 mg/L and either, High-risk CA by FISH\> OR, High LDH\> Stage I is best, Stage III is worst
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Revised International Staging System
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.24
          value
          0.8
        2. group Id
          BG001
          spread
          0.60
          value
          1.1
        3. group Id
          BG002
          spread
          0.19
          value
          0.9
        4. group Id
          BG003
          spread
          0.53
          value
          1.2
        5. group Id
          BG004
          spread
          0.49
          value
          1.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum Creatinine (mg/dL)
    unit Of Measure
    mg/dL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          43.94
          value
          201.3
        2. group Id
          BG001
          spread
          162.89
          value
          198.7
        3. group Id
          BG002
          spread
          239.56
          value
          349.0
        4. group Id
          BG003
          spread
          119.45
          value
          259.6
        5. group Id
          BG004
          spread
          144.49
          value
          249.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum LDH (U/L)
    unit Of Measure
    (U/L)
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
      title
      Serum M-spike >= 1 g/dL and urine M-spike >= 200 mg/24 hours
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          11
      title
      Serum M-spike >= 1 g/dL only
    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
          8
        5. group Id
          BG004
          value
          8
      title
      Urine M-spike >= 200 mg/24 hours only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          9
      title
      Serum immunoglobulin free light chain >= 10 mg/dL
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Parameter for response
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          16
      title
      SPEP measurement
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          17
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    (If serum M-spike), parameter followed for serum M-spike
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      18
    5. group Id
      BG004
      value
      33
    units
    Participants
groups
  1. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 100 mg, and Dexamethasone 40 mg
    id
    BG000
    title
    Phase 1: Dose Level 0
  2. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    BG001
    title
    Phase 1: Dose Level 1
  3. description
    Phase 1: Ixazomib 4.0 mg, Idasanutlin 250 mg, and Dexamethasone 40 mg
    id
    BG002
    title
    Phase 1: Dose Level 2
  4. description
    Phase 2: Ixazomib 4.0 mg, Idasanutlin 200 mg, and Dexamethasone 40 mg
    id
    BG003
    title
    Phase 2: Dose Level 1
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.60
          value
          67.3
        2. group Id
          BG001
          spread
          8.69
          value
          60.9
        3. group Id
          BG002
          spread
          12.03
          value
          63.0
        4. group Id
          BG003
          spread
          7.65
          value
          65.0
        5. group Id
          BG004
          spread
          8.19
          value
          64.2
    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
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          25
        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
          2
        5. group Id
          BG004
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          31
        title
        Not Hispanic or Latino
      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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
          0
        5. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        5. group Id
          BG004
          value
          2
        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
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          27
        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
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          11
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          19
      title
      1
    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
          2
        5. group Id
          BG004
          value
          3
      title
      2
    description
    ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction.\> ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.\> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.\> ECOG = 0 is better. ECOG = 2 is worse.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status (PS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          28
      title
      High Risk
    2. 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
          4
        5. group Id
          BG004
          value
          5
      title
      Standard Risk
    description
    Standard Risk: All others including: Trisomies t(11;14)d t(6;14).\> High Risk: t(4;14) t(14;16) t(14;20) Del 17p 53 mutation Gain 1q RISS Stage 3 High Plasma Cell S-phasec GEP: High risk signature.\> Standard Risk is best, High Risk is worst.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mayo Clinic Stratification for Myeloma and Risk-Adapted Therapy (mSMART)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          15
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          8
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
      title
      Stage III
    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
          4
        5. group Id
          BG004
          value
          4
      title
      Unknown
    5. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Missing
    description
    Stage I: Sβ2M \< 3.5 mg/L; serum albumin ≥ 3.5 g/dL\> Stage II: Sβ2M \< 3.5 mg/L; serum albumin \< 3.5 g/dL; or β2M 3.5 to 5.5 mg/L, irrespective of serum albumin\> Stage III: Sβ2M \> 5.5 mg/L\> Stage I is best, Stage III is worst.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    What was the International Staging System myeloma stage?
    unit Of Measure
    Participants
  8. classes
    1. 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
          2
        5. group Id
          BG004
          value
          3
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          25
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
      title
      III
    description
    Stage I: Sβ2M \< 3.5 mg/l, Serum albumin ≥ 3.5 g/dl, Standard-risk chromosomal abnormalities (CA) by iFISH, Normal LDH\> Stage II: Not R-ISS stage I or III\> Stage III: Sβ2M ≥ 5.5 mg/L and either, High-risk CA by FISH\> OR, High LDH\> Stage I is best, Stage III is worst
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Revised International Staging System
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.24
          value
          0.8
        2. group Id
          BG001
          spread
          0.60
          value
          1.1
        3. group Id
          BG002
          spread
          0.19
          value
          0.9
        4. group Id
          BG003
          spread
          0.53
          value
          1.2
        5. group Id
          BG004
          spread
          0.49
          value
          1.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum Creatinine (mg/dL)
    unit Of Measure
    mg/dL
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          43.94
          value
          201.3
        2. group Id
          BG001
          spread
          162.89
          value
          198.7
        3. group Id
          BG002
          spread
          239.56
          value
          349.0
        4. group Id
          BG003
          spread
          119.45
          value
          259.6
        5. group Id
          BG004
          spread
          144.49
          value
          249.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum LDH (U/L)
    unit Of Measure
    (U/L)
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
      title
      Serum M-spike >= 1 g/dL and urine M-spike >= 200 mg/24 hours
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          11
      title
      Serum M-spike >= 1 g/dL only
    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
          8
        5. group Id
          BG004
          value
          8
      title
      Urine M-spike >= 200 mg/24 hours only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          9
      title
      Serum immunoglobulin free light chain >= 10 mg/dL
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Parameter for response
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          16
      title
      SPEP measurement
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          17
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    (If serum M-spike), parameter followed for serum M-spike
    unit Of Measure
    Participants

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